NEXWAVE COMBO MUSCLE STIMULATOR SYSTEM

K111279 · Zynex Medical, Inc. · IPF · Sep 20, 2011 · Physical Medicine

Device Facts

• Record ID: K111279
• Device Name: NEXWAVE COMBO MUSCLE STIMULATOR SYSTEM
• Applicant: Zynex Medical, Inc.
• Product Code: IPF · Physical Medicine
• Decision Date: Sep 20, 2011
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 890.5850
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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, Post-traumatic and Post-surgical Pain.

Device Story

NexWave is a combination device providing Interferential (IFC), Neuromuscular Electrical Stimulation (NMES), and Transcutaneous Electrical Nerve Stimulation (TENS). Device delivers electrical pulses to patient via electrodes to stimulate nerves or muscles. Used in clinical or home settings under prescription. Healthcare providers use device to manage pain, rehabilitate muscles, and improve circulation. Output affects clinical decision-making by providing non-pharmacological pain management and physical therapy support. Benefits include pain relief, muscle atrophy prevention, and improved range of motion.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and intended use.

Technological Characteristics

Combination electrical stimulator (IFC, NMES, TENS). Powered muscle stimulator (21 CFR 890.5850). Class II device. Product codes: IPF, GZJ, LIH.

Indications for Use

Indicated for patients requiring symptomatic relief of chronic intractable, post-traumatic, or post-surgical pain (IFC/TENS modes) and patients requiring muscle re-education, prevention/retardation of disuse atrophy, increased local blood circulation, maintenance/increase of range of motion, or relaxation of muscle spasms (NMES mode).

Regulatory Classification

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.

Submission Summary (Full Text)

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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 [phone] or [phone] 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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Zvnex Medical 9990 Park Meadows Dr Lone Tree, CO 80124. Main Office: 800-495-6670 Main Fax: [phone] 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)

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

510(k) Number K111279