BUTTERFLY TONER MODEL GYM070

K093368 · Global Marketing Partners Dba Gymmax USA · NGX · Jan 27, 2010 · Physical Medicine

Device Facts

• Record ID: K093368
• Device Name: BUTTERFLY TONER MODEL GYM070
• Applicant: Global Marketing Partners Dba Gymmax USA
• Product Code: NGX · Physical Medicine
• Decision Date: Jan 27, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5850
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Butterfly Toner is indicated for the improvement of abdominal muscle tone, strengthening of the abdominal muscles, and development of a firmer abdomen.

Device Story

Butterfly Toner is a single-channel, battery-operated powered muscle stimulator designed for abdominal muscle exercise. The device features two electrodes fixed at a 28 mm distance. It utilizes an electronic stimulation controller that connects to electrodes via press-studs, eliminating the need for external cables. The device offers selectable programs and voltages to suit individual user needs. It is intended for over-the-counter use. Users cannot access internal wiring or modify the factory-set programming. By delivering electrical stimulation to the abdominal muscles, the device aims to improve muscle tone and strength, potentially benefiting the user through the development of a firmer abdomen.

Clinical Evidence

No clinical data.

Technological Characteristics

Powered muscle stimulator (21 CFR 890.5850); single-channel; battery-operated; two electrodes fixed at 28 mm; press-stud electrode connection; electronic stimulation controller with selectable programs and voltages; non-user-accessible wiring/programming.

Indications for Use

Indicated for individuals seeking improvement of abdominal muscle tone, strengthening of abdominal muscles, and development of a firmer abdomen.

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 512 (K010335)

Submission Summary (Full Text)

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K093368

# 'JAN_2' 7 2010
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## 510(k) Summary

| Date prepared: | | | |
|-------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------|-----|
| Applicant: | Global Marketing Partners dba Gymmax USA<br>3488 Rockhaven Circle<br>Atlanta, GA 30324 | | |
| Contact person: | Nicolaas C. Besseling, Consultant<br>BesTech Consulting Services<br>28711 Jaeger Drive<br>Laguna Niguel, CA 92677<br>949.466.7472<br>[e-mail] | | |
| Trade name: | Butterfly Toner | | |
| Common name: | Muscle stimulator | Class: | 2 |
| Classification name: | Powered muscle stimulator | Product code: | NGX |
| Predicate device: | Slendertone 512, K010335 | | |
| Device description: | The Butterfly Toner is a single channel, battery operated<br>muscle stimulation system for exercising the abdominal<br>muscles. The Butterfly Toner has two electrodes fixed at a<br>distance of 28 mm. | | |
| Intended use: | The Butterfly Toner is indicated for the improvement of ab-<br>dominal muscle tone, strengthening of the abdominal mus-<br>cles, and development of a firmer abdomen. | | |
| Technological characteristics: | The device has an electronic stimulation controller that<br>connects directly with "press-studs" to the electrodes, thus<br>avoiding the need for an electrode cable. The device offers<br>a selection of programs and voltages to suit individual<br>needs. The user has no access to the wiring or the connec-<br>tors, and cannot change the programming of the units. | | |
| Non-clinical tests submitted or<br>relied upon: | Waveforms as provided | | |
| Clinical tests submitted or re-<br>lied upon: | None. | | |
| Substantial equivalence con-<br>clusion: | The Butterfly Toner is substantially equivalent to the<br>Slendertone 512 because they use equivalent technology<br>and have the same intended use. | | |

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with flowing lines, representing movement or progress. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the bird symbol.

#### Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

Globus Marketing Partners dbs Gymmax USA % BesTech Consulting Services Mr. Nicolaas C. Besseling 28711 Jaeger Drive Laguna Niguel, California 92677

JAN 2 7 2010

Re: K093368

Trade/Device Name: Butterfly Toner Regulation Number: 21 CFR 890.5850 Regulation Name: Powered muscle stimulator Regulatory Class: II Product Code: NGX Dated: October 23, 2009 Received: October 29, 2009

Dear Mr. Besseling:

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, Orug, 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 A c + 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 contractly and warranties.

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 - Dr. Kelly J. Baker

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/MedicalDevices/Safety/ReportaProblem/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/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Mark N. Mallery

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

510(k) number (if known:

Device name:

...

Butterfly Toner

Indications for use:

The Butterfly Toner is indicated for the improvement of abdominal muscle tone, strengthening of the abdominal muscles, and development of a firmer abdomen.

Prescription use( Over-The-Counter use and/or V (Part 21 CFR 801 Subpart D) (Part 21 CFR 801 Subpart D)

(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation

FOR M. MELKERSON

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

510(k) Number K093368