POWERTONE, MODEL PT-11

K062439 · Johari Digital Healthcare , Ltd. · NGX · Jan 8, 2007 · Physical Medicine

Device Facts

• Record ID: K062439
• Device Name: POWERTONE, MODEL PT-11
• Applicant: Johari Digital Healthcare , Ltd.
• Product Code: NGX · Physical Medicine
• Decision Date: Jan 8, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5850
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

POWERTONE PT-11 is intended to be used for: - Improvement of abdominal tone, for strengthening of the abdominal muscles, for development of a firmer abdomen. - Strengthening, toning and firming of buttocks & thigh .

Device Story

Powertone PT-11 is a portable, battery-operated muscle stimulator for home or clinical use. It utilizes electrical muscle stimulation (EMS) to rhythmically contract muscles to improve tone and strength. The device features two output channels: one for abdominal (ABS) muscle treatment and two for buttocks/thighs (BTS) treatment. Users operate the device via an MKB panel with an LCD screen to select programs and monitor treatment time. The system includes an elastic belt, an ABS belt, and six self-adhesive electrodes. It is powered by rechargeable Ni-MH AA batteries. The device is intended for healthy adults to combine active and passive exercise. Healthcare providers or patients use the device to facilitate muscle conditioning; the output provides rhythmic electrical pulses that induce muscle contraction, potentially benefiting the user through increased muscle tone and strength.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Portable, battery-powered (4x AA Ni-MH) muscle stimulator. Features two output channels, MKB control panel, and LCD display. Includes elastic belts and six self-adhesive electrodes (50mm round and 40x80mm rectangular). Operates via electrical stimulation to induce rhythmic muscle contraction. Rechargeable via external AC/DC charger.

Indications for Use

Indicated for healthy adults seeking improvement of abdominal tone, strengthening of abdominal muscles, and strengthening, toning, and firming of buttocks and thighs.

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 BT
• Slendertone Flex Max

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo for "johari digital". The word "johari" is written in a cursive font, with a line underneath it. The word "digital" is written in a smaller, sans-serif font. To the right of the word "digital" is a graphic that looks like a digital signal.

# Johari Digital Healthca

ISO 13485 : 2003; 9001 : 2000, FDA USA Regd.

# Electronic Hardware Technology Park (100% E.O.U. Unit)

G-582, G-583, EPIP PARK, BORANADA, JODHPUR - 342 001 (Raj.) INDIA Phone : [phone] Fax E - mail : [e-mail] :: [e-mail]

Website : joharidigital.com

### Traditional 510(k) - K062439

### ANNEXURE 'VIII'

# SUMMARY

JAN - 8 2007

Johari Digital Health care Ltd. Electronic Hardware Technology Park G-582, 583 E.P.I.P.,Boranada, Jodhpur 342008 Phone: [phone],35,36 Fax[phone] E-Mail:[e-mail]

### "Traditional 510(k) summary"

| Submitter's Name | : | Nisha Johari |
|---------------------------------|---|-----------------------------------------------------------------------------------------------------------------------------------------------|
| Title | : | Director Marketing<br>JOHARI HEALTH CARE LTD<br>Electronic Hardware Technology<br>Park<br>G-582, 583<br>E.P.I.P., Boranada,<br>Jodhpur 342008 |
| Phone | : | +91-2931-281531,35,36 |
| Fax | : | [phone] |
| E-mail | : | [e-mail] |
| Contact person | : | Pooja Johari |
| Date of summary<br>is submitted | : | August 16,2006 |
| Resubmitting on | : | November 23,2006 |

8.1

Nisha Jhaw

Better life for better Today Monufacturer and Exporter of Electro-Medical Devices

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K062439
Page 2 of 3

# Traditional 510(k) - K062439

1

### ANNEXURE 'VIII'

# NEW DEVICE FOR WHICH SUBMITTING

| Trade Name | : | Powertone |
|--------------------------|---|---------------------------------------------------------------|
| Model No. | : | PT-11 |
| Common Name | : | Muscle Stimulator |
| Classification Name | : | Physical Medicine (Per 21 CFR section 890.5850) |
| LEGALLY MARKETING DEVICE | | |
| Slendertone Flex BT | : | Toning and Firming – bottoms/thighs |
| Manufacturer | : | BIO-MEDICAL RESEARCH Ltd. |
| Address | : | BMA HOUSE,<br>PARKMORE BUSINESS PARK WEST,<br>GALWAY, IRELAND |
| Slendertone Flex Max | : | Abdominal Training System |
| Manufacturer | : | BIO-MEDICAL RESEARCH Ltd. |
| Address | : | BMA HOUSE,<br>PARKMORE BUSINESS PARK WEST,<br>GALWAY, IRELAND |
| Phone | : | [phone] |
| Fax | : | [phone] |

8.2

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### Traditional 510(k) - K062439

### ANNEXURE 'VII'

### DESCRIPTION OF NEW DEVICE POWERTONE

Powertone is a Muscle stimulator with two different outputs. This battery powered unit is designed for men & women to provide exercise technology anytime-whether relaxing at home or to use as a part of exercise routine . The stimulation is the most comfortable & this technology makes it easier to combine active & passive exercise.

PT-11 stimulator provides selections of different programs through one output to treat Abdominal muscles (ABS) & through two outputs Bottom /Thighs muscles (BTS). Four body areas can be treated. LCD shows the selected program & balance treatment time.

The MKB panel with the LCD simplifies the selections. This unit is ergonomically designed, being portable it is easy and simple to use, yet works as a Clinical model (two output channels) rechargeable batteries power it. The unit can perform anytime & anywhere. Powertone is suitable for use by all healthy adults. However as with other form of exercise, some care is needed when using them. The electrical muscle stimulator (Powertone) contracts muscles rhythmically to achieve muscle tone and strength. This unit contains six self-adhesive electrodes, which can be fixed to the belt with buttons.

Powertone comes complete with all the necessary component to perform Muscle stimulation Below is a list of items that are included:

| | | Quantity |
|----|----------------------------------|----------|
| 1. | POWERTONE unit | 01 |
| 2. | Electrode cables (3 pole) | 02 |
| 3. | a) Elastic belt short style | 01 |
| | b) ABS Belt | 01 |
| 4. | Charger | 01 |
| 5. | Rechargeable Battery (AA, Ni-MH) | 04 |
| 6. | Instruction Manual | 01 |
| 7. | Carry bag | 01 |
| 8. | Electrodes- | |
| | Large(50 mm) | 02 |
| | Small (40 X 80mm) | 04 |

### INFORMATION ABOUT CHARGER

- > The Main unit is designed to work only on Battery and the charger is provided to charge the batteries.
- > Plug the DC jack of the charger into DC power socket of the main unit.
- > Plug the charger into an AC mains socket.

8.3

### Traditional 510(k) - K062439

ANNEXURE 'VII'

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Image /page/3/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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Nisha Johari Johari Digital Healthcare, Ltd. C/O Better Life Device Corporation 26540 W. Agoura Road, Suite 230 Calabases, California 91302

JAN -8 2007

Re: K062439

Trade/Device Name: Powertone PT-11 Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: NGX Dated: November 23, 2006 Received: November 30, 2006

Dear Mrs. Johari:

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 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 - Mrs. Nisha Johari

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 prematicate 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 Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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,

Marl N. Mall

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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### Indications for Use

510(k) Number (if known): K062439

Device Name: Powertone-PT-11

Indications For Use:

POWERTONE PT-11 is intended to be used for:

- Improvement of abdominal tone, for strengthening of the abdominal muscles, for development of a � firmer abdomen.
- Strengthening, toning and firming of buttocks & thigh .

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use X (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Selo Shaz

sion Sign-Off Division of General, Restorative, and Neurological Devices

**510(k) Number** LOC 2435