H-WAVE SPORT

K081998 · Electronic Waveform Laboratory, Inc. · NGX · Jul 9, 2009 · Physical Medicine

Device Facts

• Record ID: K081998
• Device Name: H-WAVE SPORT
• Applicant: Electronic Waveform Laboratory, Inc.
• Product Code: NGX · Physical Medicine
• Decision Date: Jul 9, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5850
• Device Class: Class 2

Intended Use

The H-Wave Sport is intended for muscle conditioning by stimulating muscle in order to improve or facilitate muscle performance. The H-Wave Sport is not intended to be used for therapy or treatment of medical diseases or medical conditions ..

Device Story

H-Wave Sport is a portable, battery-operated neuromuscular stimulator; used for muscle conditioning to improve performance. Device features two channels, lead wires, and self-adhesive electrodes. User operates device via two intensity dials; battery level indicator provided. Device delivers low-frequency electrical stimulation to muscles. Intended for non-medical, general fitness use; not for treatment of disease. Benefits include endurance and active recovery support.

Clinical Evidence

Bench testing only. Laboratory testing confirmed the device functioned as intended and supported the use of low-frequency stimulation for endurance and active recovery.

Technological Characteristics

Portable, battery-operated neuromuscular stimulator. Two-channel output. Includes lead wires, self-adhesive electrodes, and battery charger. Features manual intensity dials and battery level indicator. Operates via low-frequency electrical stimulation.

Indications for Use

Indicated for muscle conditioning to improve or facilitate muscle performance in healthy individuals. Not indicated for therapy or treatment of medical diseases or conditions.

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.

Predicate Devices

• H-Wave®, Electronic Waveform Lab, Inc. (K915230)
• Compex® Sport, Compex S.A. (K011880)

Submission Summary (Full Text)

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K08/998

JUL - 9 2009

### 510(k) Summary

Electronic Waveform Lab Inc.'s H-Wave® Sport

Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared

> Electronic Waveform Lab, Inc. 16168 Beach Boulevard Suite 232 Huntington Beach, CA 92647

Phone: [phone] Facsimile: [phone]

Contact Person: Ryan P. Heaney, President

Date Prepared: February 3, 2009

## Name of Device

H-Wave® Sport

## Common or Usual Name/Classification Name

Powered muscle stimulator

### Predicate Devices

H-Wave®, Electronic Waveform Lab, Inc. (K915230) Compex® Sport, Compex S.A. (K011880)

### Intended Use / Indications for Use

The H-Wave Sport is intended for muscle conditioning by stimulating muscle in order to improve or facilitate muscle performance. The H-Wave Sport is not intended to be used for therapy or treatment of medical diseases or medical conditions ..

## Technological Characteristics

The H-Wave® Sport consists of: a portable, battery operated neuromuscular stimulator with two channels, two sets of lead wires, two packages of self-adhesive electrodes and a battery charger. The H-Wave Sport stimulator is equipped with two simple dials that increase the intensity for each channel, output jacks for each channel, and a battery level indicator.

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## Performance Data

The company performed laboratory bench testing to evaluate the H-Wave Sport device. In all instances, the H-Wave® Sport functioned as intended and the results observed were as expected. Performance data supports the use of low-frequency stimulation for endurance and active recovery.

# Substantial Equivalence

The H-Wave® Sport is as safe and effective as the cleared H-Wave® and the cleared Compex® Sport. The H-Wave® Sport has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate devices. The minor technological differences between the H-Wave® Sport and its predicate devices raise no new issues of safety or effectiveness. Performance data demonstrate that the H-Wave Sport is as safe and effective as the predicate devices. Thus, the H-Wave® Sport is substantially equivalent.

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/2/Picture/2 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three overlapping figures. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the emblem.

Electronic Waveform Lab, Inc. % Mr. Ryan P. Heaney, President 16168 Beach Boulevard Suite 232 Huntington Beach, California 92647

JUL - 9 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Re: K081998

Trade/Device Name: H-Wave® Sport Regulation Number: 21 CFR 890.5850 Regulation Name: Powered muscle stimulator Regulatory Class: II Product Code: NGX Dated: June 17, 2009 Received: June 17, 2009

Dear Mr. Heaney:

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 Amendmounts, 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, isting of devices, good manufacturing practice, labeling, and prohibitions against misburanding and adulteration.

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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (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.

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# Page 2 - Mr. Ryan P. Heaney

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.htm 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.fda.gov/cdrl/mdr/ 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/cdrh/industry/support/index.html.

Sincerely yours,

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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## Indications for Use Statement

510(k) Number (if known): K081998

Device Name: H-Wave® Sport

Indications for Use:

The H-Wave Sport is intended for muscle conditioning by stimulating muscle in order to improve or facilitate muscle performance. The H-Wave Sport is not intended to be used for therapy or treatment of medical diseases or medical conditions.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

# Concurrence of CDRH, Office of Device Evaluation (ODE)

KO81948

(Division Sign-Off) (Division Signical, Orthopedic, and Restorative Devices

510(k) Number

Page 1 of 1

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