NEXWAVE COMBO MUSCLE STIMULATOR SYSTEM by ZYNEX MEDICAL, INC.

. Symptomatic relief of chronic intractable pain, post-traumatic and postsurgical pain.
Neuromuscular Electrical Stimulation Mode (NMES)
. Muscle Re-education
. Prevention or Retardation of Disuse Atrophy
. Increasing Local Blood Circulation
. Maintaining or Increasing Range of Motion
. Relaxation of Muscle Spasms
Transcutaneous Electrical Nerve Stimulation Mode (TENS)
. Management and Symptomatic Relief of Chronic Intractable Pain, Posttraumatic and Post-surgical Pain.

Device Description

Combination Neuromuscular Electrical Stimulator, Interferential Stimulator, and Transcutaneous Electrical Nerve Stimulator, Model NexWave.

AI/ML Overview

I am sorry, but the provided text from the FDA 510(k) letter for the Zynex Medical Combination Neuromuscular Electrical Stimulator, Interferential Stimulator, and Transcutaneous Electrical Nerve Stimulator, Model NexWave (K111279) does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria.

The document is a letter from the FDA to Zynex Medical, informing them that their device has been found substantially equivalent to legally marketed predicate devices. It outlines the regulatory classification, general controls provisions, and refers to the indications for use.

Crucially, it does not describe any specific performance study, clinical trial data, or detailed technical specifications related to the device's accuracy, efficacy metrics, or statistical results that would allow me to populate the requested table and answer the study-related questions. The letter focuses on the regulatory determination of substantial equivalence, not on a detailed performance evaluation report.

Therefore, I cannot provide the requested information based on the text provided.

Summary

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Food and Drug Administration 10903 New Flampshire Avenue Document Control Room -WO66-G609 Silver Spring, MID 20903-0002

Zynex Medical Incorporated % Mr. Jim Arnold 9990 Park Meadows Drive Lone Tree, Colorado 80124

SEP 2 0 2011

Re: K111279

Trade/Device Name: Combination Neuromuscular Electrical Stimulator, Interferential Stimulator, and Transcutaneous Electrical Nerve Stimulator, Model Nex Wave Regulation Number: 21 CFR 890.5850 Regulation Name: Powered musele stimulator Regulatory Class: Class II Product Code: IPF. GZJ. LIH Dated: August 11. 2011 Received: August 12, 2011

Dear Mr. Arnold:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA), You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical

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Page 2 - Mr. Jim Arnold

device-related adverse events) (21 CFR 803): good manufacturing practice requirements as set forth in the quality svstems (QS) regulation (21 CFR Part 820): and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.html for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.lda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/Medical.Devices/Resourcesfor You/Industry/default.htm.

Sincerely vours.

cerely yours,

for Peter Thomson

Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Image /page/2/Picture/0 description: The image shows the logo for Zynex Medical. The logo features the word "ZYNEX" in large, bold, sans-serif font, with the word "MEDICAL" in a smaller font size below it. A curved line arches over the word "ZYNEX", adding a dynamic element to the design.

Zvnex Medical 9990 Park Meadows Dr Lone Tree, CO 80124. Main Office: 800-495-6670 Main Fax: 800-495-6695 www.zynexmed.com

INDICATIONS FOR USE

510(k) Number:

Device Name: Combination Neuromuscular Electrical Stimulator, Interferential Stimulator, and Transcutaneous Electrical Nerve Stimulator, Model NexWave.

Indications for Use:

Interferential Mode (IFC)

. Symptomatic relief of chronic intractable pain, post-traumatic and postsurgical pain.

Neuromuscular Electrical Stimulation Mode (NMES)

. Muscle Re-education
. Prevention or Retardation of Disuse Atrophy
. Increasing Local Blood Circulation
. Maintaining or Increasing Range of Motion
. Relaxation of Muscle Spasms

Transcutaneous Electrical Nerve Stimulation Mode (TENS)

. Management and Symptomatic Relief of Chronic Intractable Pain, Posttraumatic and Post-surgical Pain.
Prescription Use M (Part 21 CFR 801 Subpart D)

ﺮ

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

Page 4-1

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K111279

Regulation Number and Section

§ 890.5850 Powered muscle stimulator.

(a)
Identification. A powered muscle stimulator is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area.(b)
Classification. Class II (performance standards).