TORC BODY

K131291 · Johari Digital Healthcare , Ltd. · NGX · Jun 14, 2013 · Physical Medicine

Device Facts

• Record ID: K131291
• Device Name: TORC BODY
• Applicant: Johari Digital Healthcare , Ltd.
• Product Code: NGX · Physical Medicine
• Decision Date: Jun 14, 2013
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 890.5850
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

TORC BODY is indicated to be used for: - Improvement of abdominal tone, for strengthening of the abdominal muscles, for development of firmer abdomen. - Strengthening, Toning and Firming of buttocks & thighs.

Device Story

TORC BODY is a battery-powered muscle stimulator for home use by healthy adults. It uses electrodes placed on the abdomen, buttocks, or thighs via elastic belts to deliver electrical stimulation. The device generates a symmetrical biphasic square wave current to rhythmically contract muscles, aiming to improve tone and strength. Users operate the device via a touch screen LCD interface to select programs and adjust intensity. The system consists of the main stimulator unit, electrode cables, belts, and a rechargeable Ni-MH battery pack. It functions as a modified version of the Powertone (K062439) device, incorporating a touch screen, updated enclosure, and higher-capacity battery. The output parameters, including current and voltage, remain consistent with the predicate. Healthcare providers do not operate the device; it is intended for patient self-use to achieve muscle conditioning benefits.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on bench testing and technical comparison of electrical output parameters and design specifications against the predicate device.

Technological Characteristics

Powered muscle stimulator; 24 VDC rechargeable Ni-MH battery; symmetrical biphasic square wave output; max output 102mApp @ 500Ω; touch screen LCD interface; ABS plastic enclosure; micro-controller controlled; circuitry treated with insulating liquid for humidity resistance.

Indications for Use

Indicated for healthy adult men and women for home use to improve abdominal tone, strengthen abdominal muscles, develop a firmer abdomen, and strengthen, tone, and firm 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

• POWERTONE, MODEL PT-11 (K062439)

Submission Summary (Full Text)

{0}------------------------------------------------

11/31291

Image /page/0/Picture/1 description: The image shows the logo for Johari Digital. The logo consists of a square divided into four smaller squares on the left, with the top right square containing a circuit board design. To the right of the square is the text "johari digital" in a stylized font, with the word "johari" in a larger font than "digital" and a registered trademark symbol next to the "i" in "johari".

Delivering Creativity & Innovation

# JUN 1 4 2013

# Summary Special 510(K)

## : JOHARI DIGITAL HEALTHCARE LTD.

Submitter's Name Contact Person Email Phone Fax Date of Summary Submission Resubmitting on

: Ms Pooja Johari : [e-mail] : 858-657-9226 : 858-220-7523 : April 26P, 2013 : Not Applicable

pooja

Name of Person and Signature (Ms Pooja Johari – Vice President Marketing)

> G582-584, EPIP, Boranada, Jodhpur - 342008, Tel: [phone] [e-mail]

{1}------------------------------------------------

Special 510(K)

Section 5 - 510(K) Summary

.

:

.

## Modified Device for Which Submitting

| Device Trade Name | : TORC BODY |
|-------------------------------|-----------------------------------------------------------------------------------------------------------------------------|
| Classification Name | : Powered Muscle Stimulator,<br>Stimulator, Muscle, Powered, For Muscle Conditioning |
| Device's Classification Panel | : Physical Medicine |
| Product Code | : NGX |
| Regulation | : 890.5850 |
| Address and Registration | : JOHARI DIGITAL HEALTHCARE LTD.<br>Electronic Hardware Technology Park<br>G-582, 584 E.P.I.P., Boranada,<br>Jodhpur 342008 |
| FDA Registration | : 8040537 |
| 510(K) No | : Not Known |

.

.

.

#### Legally Marketed Predicate Device

| Device Trade Name | : POWERTONE, MODEL PT-11 |
|--------------------------|----------------------------------|
| Classification Name | : Powered Muscle Stimulator |
| 510(K) No | : K062439 |
| Address and Registration | : JOHARI DIGITAL HEALTHCARE LTD. |
| FDA Registration | : 8040537 |

{2}------------------------------------------------

#### Description of the Modified Device:

The device description of the TORC BODY - Powered Muscle Stimulator is as follows.

TORC BODY is a powered muscle stimulator with two outputs. This battery powered unit is designed for men & women to provide exercise technology. The stimulation is the most comfortable & this technology makes it easier to combine active & passive exercise.

The TORC BODY stimulator provides selections of different programs for Bottom Thighs muscles (BTS), Abdominal muscles (ABS) & yet customization of stimulation parameters. Four body areas can be treated simultaneously.

The electrical muscle stimulator contracts muscles rhythmically to achieve muscle tone and strength. The belts provided with the device are used to place the electrodes in place on the body area to be treated. The lead wires connect the electrodes with the main stimulator unit. The Torc Body muscle stimulator provides comforting and soothing muscle stimulation to achieve the intended use of strengthening, toning and firming of the muscles of abdomen, thighs and buttocks. The user can increase the intensity to get a stronger stimulation and achieve better results.

A touch screen LCD user interface simplifies the selection of the programs and displays the selected program, treatment time and other stimulation parameters.

Rechargeable batteries power it. The unit can perform anytime & anywhere. Torc Body is suitable for use by all healthy adults. However as with other form of exercise some care is needed when using them.

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

| Item | Quantity |
|--------------------------------------|----------|
| 1. Torc Body unit | 01 |
| 2. Electrode cables (3 pole) | 02 |
| 3. Elastic belt short style | 01 |
| 4. ABS Belt | 01 |
| 4. Battery Charger | 01 |
| 5. Rechargeable Battery pack (Ni-MH) | 01 |

5.3

{3}------------------------------------------------

Section 5 - 510(K) Summary

#### Special 510(K)

- 6. Instruction Manual 01 7. Carry bag 01 8. Electrodes – Large (50 mm) 02 Small (40 mm X 80 mm) 04
#### Technical Specifications Comparison:

| Feature | Modified Device:<br>TORC PLUS | Predicate Device:<br>POWERTONE, MODEL PT-11<br>(K062439) |
|--------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Outputs | Two | Two |
| Waveform | Symmetrical Biphasic Square<br>Wave | Symmetrical Biphasic Square<br>Wave |
| Maximum<br>Output Current | 102mApp (18.97 mA rms)<br>@500Ω | 102mApp (18.97 mA rms)<br>@500Ω |
| Max output<br>voltage | 51 Vpp (9.48 Vrms) @ 500 Ω | 51 Vpp (9.48 Vrms) @ 500 Ω |
| Power Density<br>on Electrodes | 0.0089 W/cm2 @500Ω | 0.0089 W/cm2 @500Ω |
| Maximum<br>Phase Charge | 35.7μC@500Ω | 35.7μC@500Ω |
| Maximum<br>Current<br>Density | 0.176 mA/ cm2 | 0.176 mA/ cm2 |
| Maximum<br>Power Density | 0.0089 W/cm2 | 0.0089 W/cm2 |
| Feature | Modified Device:<br>TORC BODY | Predicate Device:<br>POWERTONE, MODEL PT-11<br>(K062439) |
| Indication for<br>Use | TORC BODY is indicated to be<br>used for: -<br>- Improvement of abdominal tone,<br>for strengthening of the abdominal<br>muscles, for development of firmer<br>abdomen.<br>- Strengthening, Toning and Firming<br>of buttocks & thighs. | POWERTONE is indicated to be<br>used for: -<br>- Improvement of abdominal tone,<br>for strengthening of the abdominal<br>muscles, for development of<br>firmer abdomen.<br>- Strengthening, Toning and<br>Firming of buttocks & thighs. |
| Identification | A powered muscle stimulator with<br>two different outputs, which<br>contracts the muscles of specific<br>body areas. | A powered muscle stimulator with<br>two different outputs, which<br>contracts the muscles of specific<br>body areas. |
| Target of<br>populaces | Healthy adult men & women for<br>home use. | Healthy adult men & women for<br>home use. |
| Design | 1. Torc Body is a micro -computer<br>controlled unit which works on fully<br>charged battery at 24 VDC. The unit<br>generates output (as per features) by<br>digitally controlled micro controller.<br><br>2. Microcontrollers activate signal<br>as per selected value and generates<br>the output.<br><br>3. The printed circuit board is<br>designed as per the connection of<br>component in electronic schematic<br>diagram | 1. Powertone is a micro -<br>computer controlled unit which<br>works on fully charged battery at<br>4.8 VDC. The unit generates<br>output (as per features) by digitally<br>controlled micro controller.<br><br>2. Microcontrollers activate signal<br>as per selected value and generates<br>the output.<br><br>3. The printed circuit board is<br>designed as per the connection of<br>component in electronic schematic<br>diagram |
| Mechanical Size | 8.0"(L) x 6.0"(W) x 4.0"(H)<br><br>It is ABS body enclosure --<br>ergonomically designed, so the unit<br>can be held in hand comfortably or<br>placed on a table while selecting the<br>parameter. | 3.9"(L) x 1.6"(H) x 4.0(W)<br><br>It is ABS body enclosure --<br>ergonomically designed, so the<br>unit can be held in hand<br>comfortably or placed on a table<br>while selecting the parameter |
| | | |
| Waveform | The unit Produces different current<br>waveforms, which gives the Muscles<br>stimulation of selectable program<br><br>Waveform is symmetrical biphasic<br>square wave. | The unit Produces different current<br>waveforms, which gives the<br>Muscles stimulation of selectable<br>program<br><br>Waveform is symmetrical biphasic<br>square wave. |
| User Interface &<br>Display | Touch Screen LCD User Interface.<br><br>LCD displays program mode,<br>percentage power intensity. The<br>remaining time is displayed<br>continuously. | MKB Panel and LCD Display<br>User Interface.<br><br>LCD displays program mode,<br>percentage power intensity. The<br>remaining time is displayed<br>continuously. |
| Power | Torc Body is powered by battery<br>pack 24 VDC (consisting of 20 cells<br>of NiMH 1.2 VDC, connected in<br>series). This can be charged by a<br>charger, when device is not in use<br>there by making the use SAFE for<br>the patient | Power tone is powered by four<br>rechargeable NiMH 1.2 VDC size<br>batteries. This can be charged by a<br>charger, when device is not in use<br>there by making the use SAFE for<br>the patient |
| Humidity | In order to with stand humid<br>atmosphere, insulated liquid are<br>sprayed on circuitry<br>and transformer | In order to with stand humid<br>atmosphere, insulated liquid are<br>sprayed on circuitry<br>and transformer |
| Storage | 32 F to112F | 32 F to 112F |

{4}------------------------------------------------

#### Special 510(K)

## SUBSTANTIAL EQUIVALENCE:

{5}------------------------------------------------

The modifications made to the device include:

- Name of the device from Powertone to Torc Body .
- . User Interface to incorporate a touch screen LCD
- High capacity battery from the original device to support the LCD & back light. .
- . Modified enclosure / plastic case to support touch screen and battery.

{6}------------------------------------------------

#### Special 510(K)

The intended use and indications of the modified device are the same as the intended uses and indications for the unmodified predicate device.

The modifications have not altered the fundamental technology of the sponsor's predicate device.

#### Indications for use:

TORC BODY is indicated to be used for: -

- . Improvement of abdominal tone, for strengthening of the abdominal muscles, for development of firmer abdomen.
- Strengthening, Toning and Firming of buttocks & thighs. .

{7}------------------------------------------------

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/7/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes representing the three branches of government. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

June 14, 2013

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

Johari Digital HealthCare Ltd. c/o Ms. Pooja Johari Vice President. Marketing 5703 Oberlin Dr. Suite 306 San Diego, CA 92121

Re: K131291

> Trade/Device Name: Torc Body Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: NGX Dated: April 26, 2013 Received: May 15, 2013

Dear Ms. 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 (Act) that do not require approval "approval" 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. Ilisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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

{8}------------------------------------------------

Page 2 - Ms. Pooja Johari

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,

Joyce M. Whang -S

for Victor Krauthamer, Ph.D. Acting Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation · Center for Devices and ___ Radiological.Health

{9}------------------------------------------------

# Indications for Use

510(k) Number (if known): K131291

Device Name: TORC BODY

Indications For Use:

TORC BODY is indicated to be used for:

- Improvement of abdominal tone, for strengthening of the abdominal muscles, for . development of firmer abdomen.
- Strengthening, Toning and Firming of buttocks & thighs. .

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

Over-The-Counter Use >>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>> (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)

Division Sign Off) Division of Neurological and Physical Medicine Devices (DNPMD)

510(k) Number K131291

Page 1 of 1