SPORT-ELEC, MODELS DUO CT5 SLIMNESS AND CT5 SLIMNESS

K061914 · Sport-Elec S.A. · NGX · Jul 26, 2007 · Physical Medicine

Device Facts

• Record ID: K061914
• Device Name: SPORT-ELEC, MODELS DUO CT5 SLIMNESS AND CT5 SLIMNESS
• Applicant: Sport-Elec S.A.
• Product Code: NGX · Physical Medicine
• Decision Date: Jul 26, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5850
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The CT5 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

CT5 is a 2-channel, battery-operated powered muscle stimulator designed for abdominal muscle conditioning. The system consists of an electronic stimulator module and a belt with integrated electrodes on the inner surface. The user wears the belt around the waist, secured by hook-and-loop fasteners. The device generates electrical stimulation signals delivered directly to the skin via the integrated electrodes, eliminating the need for external lead wires. It is intended for over-the-counter use by healthy individuals to improve muscle tone and strength. The user operates the device to apply transcutaneous electrical muscle stimulation (EMS). The device does not pass current from side to side and prevents user access to internal wiring. It is supplied with a conductive cream, user guide, and carry case.

Clinical Evidence

Bench testing only. Compliance with electrical safety and electromagnetic compatibility standards (IEC 60601-1, IEC 60601-2-10, IEC 60601-1-2) and software safety standards (IEC 60601-1-4) was verified. Performance was verified against FDA guidance for premarket submissions and software in medical devices.

Technological Characteristics

Battery-operated (4 batteries) 2-channel muscle stimulator. Features a wearable belt with integrated electrodes. Connectivity: None (standalone). Software: Rule-based stimulation control. Standards: IEC 60601-1, IEC 60601-2-10, IEC 60601-1-2, IEC 60601-1-4.

Indications for Use

Indicated for improvement of abdominal muscle tone, strengthening of abdominal muscles, and development of a firmer abdomen. Contraindicated for use on injured or impaired muscles. Not intended for therapy or treatment of medical conditions or 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

• SLENDERTONE FLEX ABDOMINAL Training System, TY (K030708)

Submission Summary (Full Text)

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JOL X 6 2007

## SPORT-ELEC.

## PREMARKET NOTIFICATION 510(K) SUBMISSION

Kova1914

CT5

| 5. 510(K) SUMMARY<br>[As Required by 21 CFR 807.92]<br>Summary of Safety and Effectiveness | | |
|--------------------------------------------------------------------------------------------|-------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1 | Submitter | SPORT-ELEC S.A.<br>Route de Rouen BP 35<br>27520 Bourgtheroulde<br>France |
| | Contact Person | Karine Coral / Christian Lamy |
| | | Phone number : ([phone]<br>Fax number : ([phone] |
| | Preparation date | Jan 30th 2007 |
| 2 | Device name | CT5 |
| | Trade Name | SPORT-ELEC® |
| | Common Name | Muscle stimulator |
| | Code product and classification<br>name | Stimulator, muscle, powered for muscle conditioning (NGX)<br>21 CFR Section 890.5850<br>Powered Muscle Stimulator |
| 3 | Predicate devices | SLENDERTONE FLEX ABDOMINAL Training System, TY, manufactured by<br>BIO-MEDICAL RESEARCH, LTD., K030708, cleared June 25, 2003 |
| 4 | Description | CT5 is a 2 channel battery operated muscle stimulation system specifically<br>designed to exercise the abdominal muscles. It comprises namely an<br>electronic stimulator module which generates the required stimulation<br>signals. |
| | | CT5 comprises belt with integral electrodes, which connects the signals from<br>the stimulator to the skin. The built-in electrodes are located on the inner<br>surface of the belt, which take the place of the lead wires. |
| | | The product is supplied with the cream VC 57B/53 -148, a User's Guide and<br>a carry case. |
| | Explanation of how the device<br>operates | Power is derived from 4 batteries located in a compartment protected by a<br>removable battery cover. |
| | | The electrodes are integrated in the inner surface of the belt. The garment is<br>worn as belt, and waist secured by hooks and loops fastening patches. |
| | | There is no current passed from side to side. The user cannot access the<br>wiring or connectors within the belt. |
| | Intended use | The CT5 is intended for use by healthy persons to apply trans-coetaneous<br>electrical muscle stimulation (EMS) through skin contact electrodes for the<br>following purposes: |
| 5 | <b>Performance data</b> | Testing was carried out to assure compliance with recognized electrical safety standards:<br><br>IEC 60601-1 and -2-10 standards for electrical safety<br>IEC 60601-1-2 standard for electromagnetic compatibility<br>IEC 60601-1-4 standard for the software.<br><br>Performance data were also verified versus the requirements of the FDA<br>Guidances for Pre Market Submissions and for Software contained in Medical Devices. |
| 6 | <b>Substantial equivalence summary</b> | The technological characteristics, features, specifications, materials, mode of operation, and intended use of the CT5 device are substantially equivalent to the predicate devices quoted above.<br><br>The differences that exist between the devices do not raise new issues of safety or effectiveness regarding the CT5 Device.<br><br>The CT5 is the same as the Slendertone FLEX Abdominal training system in it's delivery of the stimulation signal and has similar parameter setting. There are similar restrictions between the two devices in that electrode positioning is governed by and is integrated to the garment. |

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- Improvement of muscle tone of the muscles in the abdomen

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CT5

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with three parallel lines above them.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Lamy Christian Project Leader SPORT-ELEC S.A. Route De Rouen BP 35 27520 Bourgtheroulde Infreville, France 91400

Re: K061914

Trade/Device Name: Sport-Elec CT5 Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulators Regulatory Class: Class II Product Code: NGX Dated: July 10, 2007 Received: July 13, 2007

Dear Mr. Christian:

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

JUL 26 2007

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## Page 2 - Mr. Lamy Christian

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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket 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 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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,

sincerely yours,

Mark M. Mikkelsen

Mark N. Melkerson. M.S 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. The logo is in black and white and features the words "SPORT-ELEC" in large, bold letters. Below the main logo, the words "ELECTRO-MUSCULATION" are written in smaller letters. The logo has a registered trademark symbol on the upper right.

## CATIONS 4. INDICATIONS FOR USE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

510(k) Number (if known):

K061914

CT5

Device Name:

Indications for Use: CT5 is indicated for the improvement of abdominal muscle tone, for strengthening of abdominal muscles and for the development of a firmer abdomen

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 × AND/OR (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)

Mark A. Milliman

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

**510(k) Number** K061914