BODY CONTROL SYSTEM FAMILY, BODY CONTROL DUO AND CT5

K081026 · Sport-Elec S.A. · NGX · Nov 5, 2008 · Physical Medicine

Device Facts

• Record ID: K081026
• Device Name: BODY CONTROL SYSTEM FAMILY, BODY CONTROL DUO AND CT5
• Applicant: Sport-Elec S.A.
• Product Code: NGX · Physical Medicine
• Decision Date: Nov 5, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5850
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Body Control device is intended for use by healthy persons to apply trans-coetaneous electrical muscle stimulation (EMS) through skin contact electrodes for the following purposes; - Improvement of muscle tone of the muscles in the abdomen.

Device Story

Body Control is a 2-channel, battery-operated powered muscle stimulator for abdominal muscle conditioning. System consists of an electronic stimulator module and a belt with integrated electrodes. User wears belt secured by hook-and-loop fasteners; stimulator generates electrical signals delivered to skin via electrodes. Device is intended for OTC use by healthy individuals. Output consists of electrical stimulation signals designed to induce muscle contraction. Benefits include improved muscle tone and firmness. No user access to internal wiring or connectors; power provided by 3 batteries.

Clinical Evidence

Bench testing only. Compliance verified against IEC 60601-1 (electrical safety), IEC 60601-2-10 (particular requirements for nerve and muscle stimulators), IEC 60601-1-2 (electromagnetic compatibility), and IEC 60601-1-4 (software).

Technological Characteristics

2-channel battery-operated powered muscle stimulator. Materials include belt with integrated electrodes and conductive cream (VC 57B/53-148). Operates via trans-cutaneous electrical muscle stimulation (EMS). Standards: IEC 60601-1, IEC 60601-2-10, IEC 60601-1-2, IEC 60601-1-4. Form factor: wearable belt with electronic module. Connectivity: None.

Indications for Use

Indicated for healthy persons for improvement of muscle tone, strengthening, and development of firmer abdominal muscles. Contraindicated for injured or impaired muscles. Not for therapy or treatment of medical conditions/diseases.

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

• SPORT-ELEC ABDOMINAL Training System (Sport-Elec REF CT 5 K061914)

Submission Summary (Full Text)

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K081026

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Image /page/0/Picture/1 description: The image shows the logo for SPORT-ELEC. The logo is in black and white, with the words "SPORT-ELEC" in large, bold letters. Below the main logo, the words "ELECTRO-MUSCULATION" are written in a smaller font. The logo appears to be for a company that specializes in electro-muscle stimulation products.

## PREMARKET NOTIFICATION 510(K) TRADITIONAL SUBMISSION

Body Control

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| | | 5. 510(K) SUMMARY |
|---|-----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | [As Required by 21 CFR 807.92]<br>Summary of Safety and Effectiveness |
| 1 | Submitter | SPORT-ELEC<br>Route de Rouen<br>27520 Bourgtheroulde<br><br>S.A.<br>BP 35<br>France<br>NOV - 5 2008 |
| | Contact Person | Karine Coral / Jean Philippe Broucke |
| | | Phone number: ([phone]<br>Fax number : ([phone] |
| | Preparation date | Jan 10, 2008 |
| 2 | Device name | Body Control |
| | Trade Name | SPORT-ELEC® |
| | Common Name | Powered Muscle stimulator |
| | Product code and<br>classification name | Stimulator, muscle, powered for muscle conditioning<br>(NGX)<br>21 CFR Section 890.5850 |
| 3 | Predicate devices | SPORT-ELEC ABDOMINAL Training System,<br>manufactured by |
| | | Sport-Elec REF CT 5 K061914 Cleared July 26th<br>2007 |
| 4 | Description | Body Control is a 2 channel battery operated muscle<br>stimulation system specifically designed to exercise the<br>abdominal muscles. It is comprised of an electronic<br>stimulator module which generates the required<br>stimulation signals. |
| | | Body Control is comprised of a belt with integral<br>electrodes, which connects the signals from the<br>stimulator to the skin. The built-in electrodes are located<br>on the inner surface of the belts. The product is supplied<br>with the cream VC 57B/53 -148, a User's Guide and a<br>carry case. |
| | Explanation of how | Power is derived from 3 batteries located in a |
| | the device operates | compartment protected by a removable battery cover for<br>the Body Control. |
| | | The electrodes are integrated in the inner surface of the<br>belt. The garment is worn secured by hooks and loops<br>fastening patches. |
| | | There is no current passed from side to side. The user<br>cannot access the wiring or connectors within the belt. |

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**SPORT-ELEC**®

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## PREMARKET NOTIFICATION 510(K) TRADITIONAL SUBMISSION

The Body Control device is intended for use by healthy Intended use persons to apply trans-coetaneous electrical muscle stimulation (EMS) through skin contact electrodes for the following purposes;

> - Improvement of muscle tone of the muscles in the abdomen.

5 Performance data Testing was carried out to assure compliance with recognized electrical safety standards:

IEC 60601-1 and -2-10 standards for electrical safety

IEC 60601-1-2 standard for electromagnetic compatibility

IEC 60601-1-4 standard for the software.

Performance data was also verified versus the requirements of the FDA Guidance for Pre Market Submissions and for Software contained in Medical Devices.

## Substantial equivalence The technological summary

characteristics, features, specifications, materials, mode of operation, and intended use of the Body Control device is substantially equivalent to the predicate device quoted above.

The differences that exist between the devices do not raise new issues of safety or effectiveness regarding the Body Control Device.

The Body Control is the same as the CT5 Abdominal training system in its delivery of the stimulation signal and has similar parameter settings. There are similar restrictions between the two devices in that electrode positioning is governed by and is integrated into the garment.

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Image /page/2/Picture/1 description: The image shows the seal for the Department of Health & Human Services (USA). The seal features a stylized eagle with its wings spread, symbolizing protection and service. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Sport-Elect S.A. % FDA Registrar Corp Ms. Sharon Scannell Senior Compliance Specialist 144 Research Drive Hampton, Virginia 23666

NOV - 5 2008

K081026 Re:

> Trade Name: Body Control Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: NGX Dated: October 15, 2008 Received: October 27, 2008

Dear Ms. Scannell:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set

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Page 2 - Ms. Sharon Scannell

forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) promarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number [phone] or [phone] or the Internet address http://www.fda.gov/cdrh/industry/support/index.html

Sincerely yours,

Mark N. Mullin

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Image /page/4/Picture/0 description: The image shows the logo for SPORT-ELEC, a company specializing in electro-musculation. The words "SPORT-ELEC" are written in large, bold, sans-serif font. Below the company name, the words "ELECTRO-MUSCULATION" are written in a smaller, sans-serif font.

## PREMARKET NOTIFICATION 510(K) TRADITIONAL SUBMISSION

Body Control

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4. INDICATIONS FOR USE AND ASSOCIATIONS FOR MODE

510(k) Number (if known):

Device Name:

Body Control

Indications for Use: Body Control is indicated for the improvement of muscle tone, for strengthening of muscles and for the development of firmer muscles. It is indicated for use on the abdominal muscles.

Contraindicated use on injured or otherwise impaired muscles

Not intended for use in any therapy or for the treatment of any medical conditions or diseases

Prescription Use Over-The-Counter Use ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------(Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

CARD THE COURT FOR COURT COLLECT CAR CAR CAR SELL CONSULT AND SCHENCY U T COLL

Nithan Kumar

Vision of General, Restorative, nd Neurological Devices

:(k) **Number** k081026