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 Description

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.

AI/ML Overview

The provided text is a Special 510(k) summary for the TORC BODY powered muscle stimulator. This document focuses on demonstrating substantial equivalence to a previously cleared predicate device, the POWERTONE, MODEL PT-11 (K062439), rather than presenting a study to prove acceptance criteria for novel claims.

Therefore, many of the requested sections about specific study methodologies, sample sizes, expert qualifications, and ground truth establishment will not be directly derivable from this type of regulatory submission. The document primarily highlights the comparison of technical specifications and intended use to show that the modifications made to the TORC BODY do not raise new questions of safety or effectiveness.

Here's an analysis based on the provided text, indicating where information is present versus not applicable for this type of submission:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state acceptance criteria in terms of numerical performance targets (e.g., specific percentages for sensitivity, specificity, accuracy) for a clinical outcome. Instead, the acceptance is based on demonstrating substantial equivalence to a predicate device by comparing technical specifications and intended use. The "reported device performance" is essentially the alignment of these specifications with the predicate.

Feature	Predicate Device (POWERTONE, MODEL PT-11)	Modified Device (TORC BODY/TORC PLUS)	Statement of Equivalence/Performance
Output	Two	Two	Equivalent
Waveform	Symmetrical Biphasic Square Wave	Symmetrical Biphasic Square Wave	Equivalent
Max Output Current (@500Ω)	102mApp (18.97 mA rms)	102mApp (18.97 mA rms)	Equivalent
Max Output Voltage (@500Ω)	51 Vpp (9.48 Vrms)	51 Vpp (9.48 Vrms)	Equivalent
Power Density on Electrodes	0.0089 W/cm² @500Ω	0.0089 W/cm² @500Ω	Equivalent
Max Phase Charge (@500Ω)	35.7μC	35.7μC	Equivalent
Max Current Density	0.176 mA/cm²	0.176 mA/cm²	Equivalent
Max Power Density	0.0089 W/cm²	0.0089 W/cm²	Equivalent
Indications for Use	- Improvement of abdominal tone	- Improvement of abdominal tone	Equivalent
	- Strengthening, Toning, Firming of	- Strengthening, Toning, Firming of
	abdominal muscles, firmer abdomen	abdominal muscles, firmer abdomen
	- Strengthening, Toning, Firming of	- Strengthening, Toning, Firming of
	buttocks & thighs	buttocks & thighs
Identification	Powered muscle stimulator with two	Powered muscle stimulator with two	Equivalent
	outputs, contracting specific muscles	outputs, contracting specific muscles
Target Populace	Healthy adult men & women for home use	Healthy adult men & women for home use	Equivalent
Waveform Type	Symmetrical biphasic square wave	Symmetrical biphasic square wave	Equivalent
Humidity	Insulated liquid sprayed on circuitry	Insulated liquid sprayed on circuitry	Equivalent
Storage	32 F to 112 F	32 F to 112 F	Equivalent

Differences noted (not relevant to performance criteria in this context, but design/user interface changes):

Design: Predicate uses 4.8 VDC battery; Modified uses 24 VDC. Both are microcontroller-controlled.
Mechanical Size: Predicate: 3.9"(L) x 1.6"(H) x 4.0(W); Modified: 8.0"(L) x 6.0"(W) x 4.0"(H). (Larger form factor for the modified device).
User Interface & Display: Predicate: MKB Panel and LCD Display; Modified: Touch Screen LCD User Interface.
Power: Predicate: Four rechargeable NiMH 1.2 VDC batteries; Modified: 24 VDC battery pack (20 cells of NiMH 1.2 VDC).

The "acceptance criteria" here is that the modified device's core technological parameters and intended uses are identical to the predicate device, thereby not raising new questions of safety or effectiveness. The study demonstrating this is the comparison table itself and the accompanying narrative arguing for substantial equivalence.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable (N/A) for this type of submission. This is a Special 510(k) focused on engineering changes and demonstrating substantial equivalence to a predicate, not a new clinical trial that would require a test set of data. The "test set" is effectively the set of technical specifications and indications for use that are being compared.
The data provenance would be from internal engineering documentation and specifications of both the modified and predicate devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

N/A. Ground truth in the context of clinical studies (e.g., diagnostic accuracy) is not relevant for this engineering-focused substantial equivalence submission. The "ground truth" for the comparison is the documented specifications of the predicate device and the newly modified device.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

N/A. Adjudication methods are used in clinical trials to resolve discrepancies in expert interpretation of data. This is not applicable to a submission demonstrating substantial equivalence through technical specification comparison. The FDA's review process serves as the "adjudicator" for the claim of substantial equivalence.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

N/A. This device is a powered muscle stimulator, not an AI-driven diagnostic or assistive technology. Therefore, an MRMC study or assessment of human reader improvement with AI assistance is not relevant.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

N/A. This device is a physical medical device (muscle stimulator), not an algorithm or software. Its performance is intrinsic to its physical and electronic properties, not an "algorithm only" performance.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

N/A for clinical ground truth. The "ground truth" in this context is the technical and performance specifications of the predicate device that have already been cleared by the FDA. The justification for equivalence relies on comparing the modified device's specifications to these established (and accepted) predicate specifications.

8. The sample size for the training set

N/A. There is no "training set" in the context of this device being a physical stimulator. This term is relevant for machine learning algorithms.

9. How the ground truth for the training set was established

N/A. As there is no training set for a machine learning algorithm, there is no ground truth to establish for it.

Summary

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11/31291

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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

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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 ParkG-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

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Description of the Modified Device:

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

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

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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 SquareWave	Symmetrical Biphasic SquareWave
MaximumOutput Current	102mApp (18.97 mA rms)@500Ω	102mApp (18.97 mA rms)@500Ω
Max outputvoltage	51 Vpp (9.48 Vrms) @ 500 Ω	51 Vpp (9.48 Vrms) @ 500 Ω
Power Densityon Electrodes	0.0089 W/cm2 @500Ω	0.0089 W/cm2 @500Ω
MaximumPhase Charge	35.7μC@500Ω	35.7μC@500Ω
MaximumCurrentDensity	0.176 mA/ cm2	0.176 mA/ cm2
MaximumPower Density	0.0089 W/cm2	0.0089 W/cm2
Feature	Modified Device:TORC BODY	Predicate Device:POWERTONE, MODEL PT-11(K062439)
Indication forUse	TORC BODY is indicated to beused for: -- Improvement of abdominal tone,for strengthening of the abdominalmuscles, for development of firmerabdomen.- Strengthening, Toning and Firmingof buttocks & thighs.	POWERTONE is indicated to beused for: -- Improvement of abdominal tone,for strengthening of the abdominalmuscles, for development offirmer abdomen.- Strengthening, Toning andFirming of buttocks & thighs.
Identification	A powered muscle stimulator withtwo different outputs, whichcontracts the muscles of specificbody areas.	A powered muscle stimulator withtwo different outputs, whichcontracts the muscles of specificbody areas.
Target ofpopulaces	Healthy adult men & women forhome use.	Healthy adult men & women forhome use.
Design	1. Torc Body is a micro -computercontrolled unit which works on fullycharged battery at 24 VDC. The unitgenerates output (as per features) bydigitally controlled micro controller.2. Microcontrollers activate signalas per selected value and generatesthe output.3. The printed circuit board isdesigned as per the connection ofcomponent in electronic schematicdiagram	1. Powertone is a micro -computer controlled unit whichworks on fully charged battery at4.8 VDC. The unit generatesoutput (as per features) by digitallycontrolled micro controller.2. Microcontrollers activate signalas per selected value and generatesthe output.3. The printed circuit board isdesigned as per the connection ofcomponent in electronic schematicdiagram
Mechanical Size	8.0"(L) x 6.0"(W) x 4.0"(H)It is ABS body enclosure --ergonomically designed, so the unitcan be held in hand comfortably orplaced on a table while selecting theparameter.	3.9"(L) x 1.6"(H) x 4.0(W)It is ABS body enclosure --ergonomically designed, so theunit can be held in handcomfortably or placed on a tablewhile selecting the parameter

Waveform	The unit Produces different currentwaveforms, which gives the Musclesstimulation of selectable programWaveform is symmetrical biphasicsquare wave.	The unit Produces different currentwaveforms, which gives theMuscles stimulation of selectableprogramWaveform is symmetrical biphasicsquare wave.
User Interface &Display	Touch Screen LCD User Interface.LCD displays program mode,percentage power intensity. Theremaining time is displayedcontinuously.	MKB Panel and LCD DisplayUser Interface.LCD displays program mode,percentage power intensity. Theremaining time is displayedcontinuously.
Power	Torc Body is powered by batterypack 24 VDC (consisting of 20 cellsof NiMH 1.2 VDC, connected inseries). This can be charged by acharger, when device is not in usethere by making the use SAFE forthe patient	Power tone is powered by fourrechargeable NiMH 1.2 VDC sizebatteries. This can be charged by acharger, when device is not in usethere by making the use SAFE forthe patient
Humidity	In order to with stand humidatmosphere, insulated liquid aresprayed on circuitryand transformer	In order to with stand humidatmosphere, insulated liquid aresprayed on circuitryand transformer
Storage	32 F to112F	32 F to 112F

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Special 510(K)

SUBSTANTIAL EQUIVALENCE:

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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.

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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. .

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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

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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

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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

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).