Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description focuses on electrical muscle stimulation and user-selectable programs, with no mention of AI or ML technologies.

Therapeutic

Yes
This device is a powered muscle stimulator intended for strengthening, toning, and firming muscles, which are therapeutic claims.

Diagnostic

No

The device is described as a powered muscle stimulator intended for strengthening, toning, and firming muscles, not for diagnosing medical conditions.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a "powered muscle stimulator with two outputs" and mentions physical components like "belts," "electrodes," "lead wires," and a "main stimulator unit." This indicates it is a hardware device, not software-only.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is for improving muscle tone, strengthening, toning, and firming of abdominal, buttocks, and thigh muscles. This is a physical effect on the body, not a diagnostic test performed on samples taken from the body.
Device Description: The device is a powered muscle stimulator that applies electrical stimulation to the body. It does not analyze biological samples (like blood, urine, tissue, etc.) to provide diagnostic information.
Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions

The device falls under the category of a physical therapy or exercise device that uses electrical stimulation for muscle conditioning.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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. .

Product codes (comma separated list FDA assigned to the subject device)

NGX

Device Description

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:

Torc Body unit
Electrode cables (3 pole)
Elastic belt short style
ABS Belt
Battery Charger
Rechargeable Battery pack (Ni-MH)
Instruction Manual
Carry bag
Electrodes – Large (50 mm)
Small (40 mm X 80 mm)

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Abdomen, buttocks & thighs.

Indicated Patient Age Range

Healthy adult men & women

Intended User / Care Setting

home use.

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Not Found

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K062439

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 890.5850 Powered muscle stimulator.

(a)
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.(b)
Classification. Class II (performance standards).

Summary

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 : pooja.johari@7ellc.com : 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: +91-02931-281531/36 info@joharidigita.com

1

Special 510(K)

Section 5 - 510(K) Summary

.

:

.

Modified Device for Which Submitting

Device Trade Name	: TORC BODY
Classification Name	: Powered Muscle Stimulator,
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.
Electronic Hardware Technology Park
G-582, 584 E.P.I.P., Boranada,
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)

1. 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:
TORC PLUS | Predicate Device:
POWERTONE, MODEL PT-11
(K062439) |
|--------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Outputs | Two | Two |
| Waveform | Symmetrical Biphasic Square
Wave | Symmetrical Biphasic Square
Wave |
| Maximum
Output Current | 102mApp (18.97 mA rms)
@500Ω | 102mApp (18.97 mA rms)
@500Ω |
| Max output
voltage | 51 Vpp (9.48 Vrms) @ 500 Ω | 51 Vpp (9.48 Vrms) @ 500 Ω |
| Power Density
on Electrodes | 0.0089 W/cm2 @500Ω | 0.0089 W/cm2 @500Ω |
| Maximum
Phase Charge | 35.7μC@500Ω | 35.7μC@500Ω |
| Maximum
Current
Density | 0.176 mA/ cm2 | 0.176 mA/ cm2 |
| Maximum
Power Density | 0.0089 W/cm2 | 0.0089 W/cm2 |
| Feature | Modified Device:
TORC BODY | Predicate Device:
POWERTONE, MODEL PT-11
(K062439) |
| Indication 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. | POWERTONE 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. |
| Identification | A powered muscle stimulator with
two different outputs, which
contracts the muscles of specific
body areas. | A powered muscle stimulator with
two different outputs, which
contracts the muscles of specific
body areas. |
| Target of
populaces | Healthy adult men & women for
home use. | Healthy adult men & women for
home use. |
| Design | 1. Torc Body is a micro -computer
controlled unit which works on fully
charged battery at 24 VDC. The unit
generates output (as per features) by
digitally controlled micro controller.

Microcontrollers activate signal
as per selected value and generates
the output.
The printed circuit board is
designed as per the connection of
component in electronic schematic
diagram | 1. Powertone is a micro -
computer controlled unit which
works on fully charged battery at
4.8 VDC. The unit generates
output (as per features) by digitally
controlled micro controller.
Microcontrollers activate signal
as per selected value and generates
the output.
The printed circuit board is
designed as per the connection of
component in electronic schematic
diagram |
| Mechanical Size | 8.0"(L) x 6.0"(W) x 4.0"(H)

It is ABS body enclosure --
ergonomically designed, so the unit
can be held in hand comfortably or
placed on a table while selecting the
parameter. | 3.9"(L) x 1.6"(H) x 4.0(W)

It is ABS body enclosure --
ergonomically designed, so the
unit can be held in hand
comfortably or placed on a table
while selecting the parameter |
| | | |
| Waveform | The unit Produces different current
waveforms, which gives the Muscles
stimulation of selectable program

Waveform is symmetrical biphasic
square wave. | The unit Produces different current
waveforms, which gives the
Muscles stimulation of selectable
program

Waveform is symmetrical biphasic
square wave. |
| User Interface &
Display | Touch Screen LCD User Interface.

LCD displays program mode,
percentage power intensity. The
remaining time is displayed
continuously. | MKB Panel and LCD Display
User Interface.

LCD displays program mode,
percentage power intensity. The
remaining time is displayed
continuously. |
| Power | Torc Body is powered by battery
pack 24 VDC (consisting of 20 cells
of NiMH 1.2 VDC, connected in
series). This can be charged by a
charger, when device is not in use
there by making the use SAFE for
the patient | Power tone is powered by four
rechargeable NiMH 1.2 VDC size
batteries. This can be charged by a
charger, when device is not in use
there by making the use SAFE for
the patient |
| Humidity | In order to with stand humid
atmosphere, insulated liquid are
sprayed on circuitry
and transformer | In order to with stand humid
atmosphere, insulated liquid are
sprayed on circuitry
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 (800) 638-2041 or (301) 796-7100 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 (800) 638 2041 or (301) 796-7100 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

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