The document summarizes a literature review of clinical data for the Zynex Medical NeuroMove 900, an EMG-triggered neuromuscular electrical stimulation device. The review found evidence that equivalent devices were effective in improving function for stroke, spinal cord injury, and traumatic brain injury based on their similar intended use, method of application, patient populations, and critical performance characteristics. The NeuroMove 900 was determined to be clinically and technically equivalent to predicate devices like the AutoMove 800, indicating it is safe and effective for its intended use.

1. •
Zynex Medical NeuroMove 900
EMG‐Triggered Neuromuscular Electrical Stimulation Device
Clinical Data Literature Review
• Purpose of this Review
This report is an analysis and summary of literature reviewed for the Zynex Medical NeuroMove 900
Neuromuscular Electrical Stimulation Device (NMES) family in accordance with MDD 93/42/EEC as
amended by Directive 2007/47/EC Annex X, Literature Review Route requirements; specifically, the
Zynex Medical NeuroMove 900 Neuromuscular Electrical Stimulation Device (NMES) .
As a general rule, confirmation of conformity with the requirements concerning the characteristics and
performances referred to in Sections 1 and 3 of Annex I, under the normal conditions of use of the
device, and the evaluation of the side‐effects and of the acceptability of the benefit/risk ratio referred to
in Section 6 of Annex I, must be based on clinical data. The evaluation of this data hereinafter referred
to as “clinical evaluation”, where appropriate taking account of any relevant harmonized standards must
follow a defined and methodologically sound procedure based on:
Either a critical evaluation of the relevant scientific literature currently available relating to the
safety, performance, design characteristics, and intended purpose of the device where:
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There is demonstration of equivalence of the device to the device to which the data relates,
and
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The data adequately demonstrate compliance with the relevant essential requirements.
•
Or a critical evaluation of the results of all clinical investigations made.
•
Or a critical evaluation of the combined clinical data provided in 1 and 2.
This analysis is based on relevant scientific literature currently available relating to the NeuroMove 900
EMG‐Triggered NMES device in the aspects of safety, performance, design characteristics, and intended
purpose. The literature reviewed was based on a demonstration of equivalence of the device to the
device(s) that we have in place in the market.
Description of the Device:
The NeuroMove 900 (NM) device is designed to be easy to operate and to be utilized in the home as an
adjunct to other therapies. The NM is based on the Pavlov’s Dog theory that repetition and reward for
attaining a goal can retrain the brain.

2. Device Intended functions:
The primary function of the NM is to help people regain function lost as a result of a stroke, spinal cord
or traumatic brain injury.
Device intended purpose:
NeuroMove 900
The NeuroMove 900 emg‐triggered electrical stimulation device is intended to be used to help regain
lost function in the limbs due to stroke, spinal cord injury and traumatic brain injury. It can be used as
an adjunct to other therapies such as physical or occupational. The NeuroMove 900 is indicated in the
treatment of the following conditions:
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Stroke
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Spinal Cord Injury
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Traumatic Brain Injury
Device application of use:
Only the user can evaluate the clinical factors involved with each patient to determine if the use of this
device is indicated. The user must then decide on the specific technique and procedure that will best
accomplish the desired clinical effect.
Two active electrode pads are placed on the active muscle and one ground electrode is placed on the
skin. A stimulation level measured in mA is set to desired feeling and visible contraction of the muscle.
The patient thinks about moving the muscle (ie: opening the hand) with the electromyography (emg)
activity visible at the bottom of the display screen and a threshold automatically set by the device
according to how well the user is concentrating. Once the emg activity strikes through the threshold, the
patient is told good and is rewarded with a muscle stimulation and contraction. There are three steps to
the cycle READY, GOOD and RELAX. The device has audio that prompts the patient through each step of
the cycle to keep them motivated for the duration of the sessions. Two sessions per day for 20 – 30
minutes per treatment are recommended for maximum benefit.
• Manufacturer Statement
The clinical efficacy of the NeuroMove 900 EMG‐Triggered Electrical Stimulation Device has been
established through review of the published literature and clinical experience. The available reports on
the technology, and the specific application and clinical experience of the technology for emg‐triggered
devices demonstrate no new issues of risk and safety of the use of this technology, beyond the known
product experience and engineering evaluations performed in support of this technology by Zynex

3. Medical, Inc. This documentation of clinical experience is sufficient to demonstrate conformity to those
essential requirements set in Annex I of MDD 93/42/EEC.
The equivalence of the NeuroMove 900 and the reviewed devices was established through intended
mechanism of action, which is increased function through mental practice and emg‐triggered electrical
stimulation.
• Clinical Data Report
Methodology
•
GENERAL
A systematic review for the relevant literature has been performed to substantiate indications for emg‐
triggered muscle stimulation. We searched the Cochrane Central Register of Controlled Trials, MEDLINE,
PubMed, and Embase databases to identify clinical studies describing outcomes associated with
equivalent devices. The identified studies were screened for relevance. Only studies reporting clinical
outcomes of human studies were retained. Data about the study design, disease, or condition treated
(patient population); sample size, and efficacy and safety outcomes were systematically abstracted from
the publications. Then, the evidence was reviewed by senior clinician in light of the NeuroMove 900
indication claims.
Objective
The objective of the literature review was to evaluate safety and efficacy of devices equivalent to the
NeuroMove 900.
Identification of data
Searches were restricted to studies examining human subjects.
Relevant published clinical studies were identified b the following strategies:
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Computer aided searching of PUBMED;
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Computer aided search of EMBASE;
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Computer aided search of Cochrane Central Register of Controlled Trials;
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The Database of Abstracts of Reviews of Effectiveness (Cochrane Library);
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Manufacturer internal bibliography;
•
Reference lists checking from the papers identified by the above strategies.
The search strategy used to find relevant articles for emg‐triggered electrical stimulation technology are
limited to trials that do not include meta‐analysis or systemic reviews. The studies obtained are also
limited to the upper extremity for post stroke survivors.

4. Search strategy for emg‐triggered electrical muscle stimulation
The following computer aided search strategy was used to identify studies reporting outcomes of
treatments involving emg‐triggered electrical muscle stimulation:
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emg
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emg triggered electrical stimulation
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electromyography
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stimulation
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1 OR 2 OR 3 OR 4
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stroke
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function
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hemiplegia
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increase function
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upper extremity
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stroke assessment
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motor activity
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arm function
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cerebrovascular accident
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5 OR 6 OR 7 OR 8 OR 9 OR 10 OR 11 OR 12 OR 13 OR 14
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Randomized controlled trial [Publication Type]
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Meta‐analysis [Publication Type]
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5 OR 15 OR 16 OR 17
Abstracts of all retrieved studies were reviewed by three independent reviewers for relevance.
Discrepancies were resolved by reaching mutual agreement. Studies not reporting patient outcomes and
cadaver studies were excluded.
For each study, assessment of the methodological quality and data extraction were carried out as
detailed below:
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Three reviewers with strong product knowledge selected to be included in the review.

5. •
Disagreement was resolved by discussion.
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The type of the study design was assessed.
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For each study, the following information was abstracted: study design; condition or diagnosis;
patient population; sample size; spinal levels involved; type of surgical intervention in the
experimental and the control group; follow‐up period; and, the device approval status.
Relevance of the data
Literature clinical data were collected on emg‐triggered electrical stimulation (equivalent devices):
EMG‐Triggered Electrical Nerve Stimulation
•
AutoMove 800 ‐
This predicate device is substantially equivalent to the NM 900 based on comparison of their clinical use,
technical characteristics, and biological characteristics, as described below. The substantial equivalence
rationale described below is based on requirements and guidance per MEDDEV 2.7.1, Guidelines for
medical devices – Evaluation of clinical data: A guide for manufacturers and notified bodies; ISO 14155‐
1:2003, Clinical investigation of medical devices for human subjects – Part 1: General requirements; and
GHTF SG5(PD)N2R7, Clinical evaluation. Combined review of evidence about efficacy and safety of emg‐
triggered stimulation devices provides a comprehensive and clinically relevant evidence base about
emg‐triggered electrical nerve stimulation efficacy and safety.
Clinical equivalence
The NeuroMove 900 device is used for the same clinical indications as the other referenced emg‐
triggered electrical stimulation devices. There is supportive evidence for use of the equivalent devices
for each of the clinical conditions for which emg‐triggered stimulation is indicated. The Table below
illustrates a comparison of the indications for use of the NeuroMove 900 and the predicate devices.
NeuroMove 900 Indications for Use
Stroke
Spinal cord injury
Traumatic brain injury
Increase finger movement
Increase hand/wrist movement
Increase dorsiflexion
Increase elbow movement
Increase shoulder movement
Decrease muscle spasms
AutoMove
800
X
X
X
X
X
X
X
X
X
The critical performance relevant for each indication within the intended use is the same for
NeuroMove 900 and for the equivalent devices.

6. Based on (i) equivalence of the intended use, (ii) method of application in the body, (iii) similar patient
population, and (iv) critical performance necessary to achieve the expected clinical effect, the clinical
characteristic of the NeuroMove 900 device is equivalent to the predicate AutoMove 800 device.
Technical equivalence
The NeuroMove 900 has the same or similar technical characteristic as other referenced emg‐triggered
muscle stimulation devices.
The key aspects of the NeuroMove 900 design are also found in the equivalent devices. All of the emg‐
triggered stimulation devices work by attaching non‐invasive electrode pads over the muscle and setting
a stimulation level (mA) to see visible movement of the muscle and feel the stimulation. The specific
geometry of the NM 900 device is comparable to all of the predicate devices.
Based on similarities in the basic design features, geometry, size, shape, materials and strength, and the
conditions of use, the technical characteristics of the NM 900device are substantially similar to the
predicate devices.
Also, mechanical testing demonstrates comparable mechanical properties to predicate devices. Thus,
the NeuroMove 900 device is substantially equivalent to predicate devices.
Assessment of clinical data
Based on the critical evaluation of the literature, there is a substantial body of evidence to support
efficacy of equivalent devices for the indications and type of applications claimed for emg‐triggered
electrical stimulation, evidence supports efficacy of emg‐triggered electrical stimulation for stroke,
spinal cord injury, traumatic brain injury, increased movement, increased hand/wrist movement,
increased dorsiflexion, increased elbow movement, increased shoulder movement and to decrease
muscle spasms.
Overall, there is a support for favorable benefit for the NeuroMove 900 device based on the review
overview of clinical outcomes for equivalent devices.
Critical evaluation of the literature
Critical evaluation of the literature has been performed by Tara Miller, Clinical Development; Jim Arnold,
Manager Quality and Regulatory Affairs; and Bob Cozart, Vice President, Technical Operations.
•
CHRONIC MOTOR DYSFUNCTION
Stroke is the number one cause of functional disability in this country with approximately 795,000
strokes occurring annually. Voluntary movement control is typically impaired after a stroke. The specific
neurological mechanisms that mediate neuromuscular recovery are still not understood. Evidence
suggests that some motor recovery occurs because the auxiliary cortex areas may take over some
functions.
Efficacy
The purpose to determine the effect of emg‐triggered electrical stimulation on wrist and extensor
muscles in individuals post stroke ≥ 1 year. (Cauraugh J, 2000)

7.
Investigators suggest that the benefit in these studies stems from proprioceptive afferent feedback that
accompanies motor stimulation as it is well known that afferent input affects motor centers at the spinal
and supraspinal levels. (Kimberley TJ, 2002 )
In a controlled, double blind study design, Kimberly et al studied the effect of intensive in home NMES
treatments in 16 post stroke survivors for 60h/3 weeks compared to sham treatment. The findings show
that NMES may play an important role in stimulating cortical sensory areas to allow for improved motor
function. (Kimberely TJ, 2004)
Results
Eleven individuals voluntarily participated and were randomly assigned to emg‐triggered stimulation
group (7 subjects) or the control group (4 subjects). The block and box test and force‐generation task
(sustained muscular contraction) revealed significant findings (P<0.05). The experimental group moved
more blocks and displayed higher isometric force impulse after rehab treatments. (Cauraugh J, 2000)
In a pilot, randomized, single blinded trial, nine subjects were assessed for upper extremity Fugl‐Meyer
motor assessment and the feeding, grooming and upper body dressing items of the FIM at entry and at
discharge. The subjects treated with emg‐triggered stimulation demonstrated greater gains in Fugl‐
Meyer (27.0 vs 10.4; p = .05) and FIM (6.0 vs 3.4; p = .02). Data suggests that the emg‐triggered
electrical stimulation increases arm function for stroke survivors. (Francisco G, 1998)
COUPLED MOTOR RECOVERY
Efficacy
Studies investigating the use of both emg‐triggered electrical stimulation and bilateral coordination
together provide evidence that coupled protocols might assist patients to expand their motor skills
further. In a randomized study including 25 stroke survivors assigned to 0ne of three groups: 1) coupled
protocol and bilateral movement (n=10), emg‐triggered electrical stimulation and unilateral movement
(n=10) and 3) control (n=5), motor capabilities were evaluated on the basis of three categories of motor
tasks in a pre and post test design. Significant findings for the three groups favored coupled emg‐
triggered electrical stimulation and coupled bilateral movement training. (Cauraugh JH K. S., 2002)
Results
Evidence demonstrates a significant decrease in hemiparegic wrist and fingers for post CVA patients.
The coupled protocol group was able to achieve increase in voluntary controls across the three
categories of tasks. (Cauraugh JH K. S., 2002)
Combination of coupled protocols with emg‐triggered electrical stimulation and bilateral coordination
movement produce intralimb transfer evidence for distal practice and proximal joint combination
benefits. (Cauraugh JH K. S., 2005)

8. Clinical Update
Zynex Medical is currently waiting for preliminary results for a multi‐center randomized study
(ClinicalTrials.gov identifier: NCT00142792) to evaluate functional electrical stimulation (FES) for upper
extremity in stroke. This is a multi‐center, randomized clinical study to evaluate the clinical outcome of
subjects post stroke with FES to emg‐triggered electrical stimulation.
There are currently a total of 189 subjects enrolled
The following list is the Sites:
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MetroHealth Medical Center; Cleveland, OH United States
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University of Cincinnati College of Medicine; Cincinnati, OH United States
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Edwin Shaw Rehab; Akron, OH United States
Eligibility
Ages Eligible for Study:
Genders Eligible for Study:
Accepts Healthy Volunteers:
21 Years to 75 Years
Both
No
Criteria
Inclusion Criteria:
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Age between 21 and 75 years
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Evidence of clinical symptoms from a hemorrhagic or non hemorrhagic stroke with all symptoms
from previous stroke(s) completely resolved
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Medically stable
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Less than 6 months post stroke
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Intact skin on hemiparetic side
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Able to follow 3‐stage commands
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Able to recall 2/3 objects after 30 minutes
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Full passive ROM at the wrist and thumb, index and long finger MCP jints on the affected side
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Presence of detectable, volitionally‐activated EMG signal from the paretic wrist or finger
extensors (ECR or EDC)

9. •
Affected wrist extensors ≤ 4 on the MRC scale
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Score of ≤ 11/14 on Section C (hand) of UE portion of Fugel‐Meyer Assessment (FMA)
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Ability to tolerate NMES to the ECR and EDC for full wrist finger extension
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Caregiver available to assist with the device every day (unless subject is capable of using it
independently)
Exclusion Criteria:
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History of ventricular arrythmias or any other arrythmias (i.e. fast atrial fibrillation, ventricular
tachycardia or supraventricular tachycardia) with hemodynamic instability
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History of other upper motor neuron lesion
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Absent sensation of affected limb
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Pregnancy
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History of more than one seizure per month during last year (or, since the stroke if no seizures
prior to stroke)
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Discharge to skilled nursing facility or long term care facility (EXCEPTION: Subjects may be d/c’d
to the 6A SNF unit at MetroHealth Medical Center)
Conclusion
A number of the literature references are cited from textbooks, since the design, principles of operation,
and the use of emg‐triggered electrical muscle stimulation is so well established.
The information presented in this summary indicates that efficacy associated with use of emg‐triggered
electrical stimulation devices is well‐known and well‐described in the medical literature. To the best of
the Company’s knowledge, the potential complications that may be associated with the use of the
NeuroMove 900 do not differ from those described in the literature summary above for similar emg‐
triggered stimulation devices.
The data that is now available adequately demonstrates compliance with the relevant essential
requirements. As indicated in this Clinical Evaluation section, the current feedback for the NeuroMove
900 s is very positive and further formal feedback data is envisaged. There are no contra‐indications
such that NeuroMove devices cannot be on the market as a Class IIb medical device.

10. Signature Page
I confirm that I have conducted and supervised the process of the Clinical Evaluation for the NeuroMove
900 emg‐triggered electrical muscle stimulation device.
Based on (i) equivalence of the intended use, (ii) method of application in the body, (iii) similar patient
population, and (iv) critical performance necessary to achieve the expected clinical effect, the clinical
characteristics of the NeuroMove 900 devices are equivalent to the other emg‐triggered stimulation
devices.
In considering the risks of the use of emg‐triggered electrical muscle stimulation devices identified,
NeuroMove 900, as well as in this clinical literature based evaluation, versus the benefits of its use, the
benefits of its use clearly outweigh the risks when applied according to established indications and
instructions for use.
Tara Miller
Clinical Development
Jim Arnold
Manager, Quality Assurance
Bob Cozart
Vice President, Technical
Operations
Reference List
Cauraugh J, L. K. (2000). Chronic Motor Dysfunction After Stroke Recovering Wrist and Finger Extension
by Electromyography‐Triggered Neuromuscular Stimulation. Stroke , 1360‐1364.
Cauraugh JH, K. S. (2005). Coupled Bilateral Movements and Active Neuromuscualr Stimulation:
Intralimb Transfer evidence During Bimanual Aiming. Neuroscience Letters , 39‐44.
Cauraugh JH, K. S. (2002). Two Coupled motor Recovery Protocols Are Better Than One Electromyogram‐
Triggered Neuromuscular Stimulation and Bilateral Movements. Stroke , 1589‐1594.
Francisco G, C. J. (1998). Electromyogram‐Triggered Neuromuscular Stimulation for Improving the Arm
Function of Acute Stroke Survivors: A Randomized Pilot Study. Arch Phys Med Rehabil , 570‐575.
Kimberely TJ, L. S. (2004). Electrical Stimulation Driving Functional Improvements and Cortical Changes
in Subjects with Stroke. Exp Brain Res , 450‐460.
Kimberley TJ, C. J. (2002 ). Neuromuscular Electrical Stimulation in Stroke Rehabilitation. Minnesota
Medical Association , 45‐48.