Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on electrical stimulation and user interface improvements, with no mention of AI or ML algorithms for controlling stimulation or analyzing patient data.

Therapeutic

Yes
The device is described as a "Powered Muscle Stimulator" intended to improve tone and strengthen muscles, which aligns with the definition of a therapeutic device designed to treat or alleviate a medical condition or improve bodily function.

Diagnostic

No
The device description states its purpose is to improve tone and strengthen muscles by generating electrical stimulation, not to diagnose any condition.

SaMD (Software as a Medical Device)

No

The device description explicitly mentions hardware components like an "Internal power supply" and a "wheeled console," indicating it is not solely software.

IVD (In Vitro Diagnostic)

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

Here's why:

Intended Use: The intended use is for improving abdominal tone, strengthening muscles, and firming the abdomen, buttocks, and thighs. This is a direct physical interaction with the body to achieve a therapeutic or aesthetic outcome.
Device Description: The device is a Powered Muscle Stimulator that generates electrical stimulation to contract muscles. This is an external physical intervention.
Lack of In Vitro Activity: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) outside of the body. IVDs are specifically designed for testing these types of samples.

The Torc Body is a medical device, but it falls under the category of a physical therapy or aesthetic device that directly interacts with the body's muscles.

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

Torc Body, the Powered Muscle Stimulator, is intended to improve tone and strengthen the muscles of the abdomen, buttocks, and thighs and to firm the abdomen muscles.

The modified Torc Body, as described in this submission, is an upgrade from its previous version; which includes User- Friendly GUI, Internal power supply, and a wheeled console allowing clinicians to navigate and operate the device effortlessly. We intend to market this device to clinicians, as a prescription device. For ease of use and operation for the clinicians, we have 3 modes (suggestive):

. CLASSIC VECTOR is only necessary for non-active patients. It creates a twisting motion to warm up, build blood circulation and slowly build a tolerance to muscle contractions.
POWER SEQUENCE contracts the muscles, holds it and then relaxes it to increase strength and muscle endurance.
DYNAMIC ROTATION - Fast, sequential contractions of the muscles which leads to toning and firming.

The modified device generates electrical stimulation to contract the muscles rhythmically to achieve the intended use of strengthening, firming, and toning the muscles of the abdomen, thighs, and buttocks.

While redesigning the Torc Body, complete care and considerable measures have been taken to retain its safety and effectiveness. Torc Body device complies with voluntary standards.

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

adults only.

Intended User / Care Setting

clinicians

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)

Non-Clinical Testing:
The following bench testing was conducted for design and performance elements deemed appropriate to demonstrate equivalence to the previously cleared Torc Body device. The modified device Torc Body met the predetermined acceptance criteria ensuring substantial equivalence to the previously cleared device. No new safety or performance issues were raised during testing.

Non-Clinical Bench Testing:

Reliability Testing
Compliance Testing (IEC60601-1, IEC60601-1-2
Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)
Quality System Regulation (21CFR820)
Application of usability engineering to medical devices (IEC 62366)
Application of risk management to medical devices (ISO 14971)
Symbols to be used with medical device labels, labelling and information to be supplied (ISO 15233)
Biological evaluation of medical devices (ISO 10993-1)

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.

K131291

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

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

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

March 29, 2020

Johari Digital Healthcare Limited Pooja Johari Founder and Director Marketing G-582, 584 EPIP, Boranada Jodhpur, Rajsthan 342008 India

Re: K192039

Trade/Device Name: Torc Body Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: NGX Dated: December 24, 2019 Received: December 30, 2019

Dear Pooja 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 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

1

801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

For Vivek Pinto, PhD Director DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

2

Indications for Use

510(k) Number (if known) K192039

Device Name Torc Body

Indications for Use (Describe)

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.

Type of Use (Select one or both, as applicable)
☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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3

510 (k) Summary As required by 21 CFR 807.92(c)

Device Name	Torc Body
Submitters name/
contact details	Nisha Johari
Johari Digital Healthcare Ltd
G-582, 584 EPIP, Boranada,
Jodhpur - India - 342008
Contact number: + 1-888-412-3160
Summary Preparation Date	20-Mar-2020
Device Trade Name	Torc Body
Device / Proprietary Name	Torc Body
Common Name	Stimulator, Muscle, Powered, for Muscle Conditioning
Classification Name	Powered Muscle Stimulator,
Stimulator, Muscle, Powered, For Muscle Conditioning
Classification Regulation	21 CFR 890.5850, Class II
Classification Product Code	NGX

Legally marketed Predicate Device

Device Trade Name	Torc Body
Classification Name	Powered Muscle Stimulator,
Stimulator, Muscle, Powered, For Muscle Conditioning
510(K) No	K131291
Address and Registration	Johari Digital Healthcare Ltd
G-582, 584 EPIP, Boranada,
Jodhpur - India - 342008
Contact Person:	Nisha Johari
Contact Number:	+91-9829954228
FDA Registration	8040537

4

Device Description

Torc Body, the Powered Muscle Stimulator, is intended to improve tone and strengthen the muscles of the abdomen, buttocks, and thighs and to firm the abdomen muscles.

The modified Torc Body, as described in this submission, is an upgrade from its previous version; which includes User- Friendly GUI, Internal power supply, and a wheeled console allowing clinicians to navigate and operate the device effortlessly. We intend to market this device to clinicians, as a prescription device. For ease of use and operation for the clinicians, we have 3 modes (suggestive):

. CLASSIC VECTOR is only necessary for non-active patients. It creates a twisting motion to warm up, build blood circulation and slowly build a tolerance to muscle contractions.
POWER SEQUENCE contracts the muscles, holds it and then relaxes it to increase strength and muscle endurance.
DYNAMIC ROTATION - Fast, sequential contractions of the muscles which leads to toning and firming.

The modified device generates electrical stimulation to contract the muscles rhythmically to achieve the intended use of strengthening, firming, and toning the muscles of the abdomen, thighs, and buttocks

While redesigning the Torc Body, complete care and considerable measures have been taken to retain its safety and effectiveness. Torc Body device complies with voluntary standards.

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.

The device safety and efficacy was demonstrated by performance data and comparison of technical characteristics between the modified device and the predicate device.

Substantial Equivalence:

The intended use and indication for use of the modified device are the same as the predicate device (Torc Body , K131291). The modification made to the device include:

User Friendly GUI- LCD with wide angle view that significantly facilitates the use of the device.
Power Supply- Internal power supply in place of external AC/DC adaptor and rechargeable battery. Wheeled Console- Allows clinicians to navigate and operate the device effortlessly
Prescriptive device- we intend to market this device to clinicians, we propose making it a prescription device.

5

Comparison of Technological Characteristics

A comparison below given below identifies all the changes between the modified and the predicate device:

Device Features	Modified Device	Predicate Device	Comparison
510(K) Number	K192039	K131291	N/A
Device Name,
Model	Torc Body	Torc Body	Design revision updated
to V2.0
Manufactured For	7E LLC	7E LLC	Identical
Manufactured By	Johari Digital
Healthcare Ltd.	Johari Digital
Healthcare Ltd.	Identical
Classification Name	Powered muscle
stimulator	Powered muscle
stimulator	Identical
Product Code	NGX	NGX	Identical
Regulation Number	21 CFR 890.5850	21 CFR 890.5850	Identical
Panel	Physical Medicine	Physical Medicine	Identical
Class	Class II	Class II	Identical
Prescription/OTC	Prescription	OTC	Modified;
We intend to market this
device to clinicians and
propose making it a
prescription device.
Indication for use	Improvement of
abdominal tone,
for strengthening
of the abdominal
muscles, for
development of
firmer abdomen.
Strengthening,
toning and
firming of
buttocks &
thighs.	Improvement
of abdominal
tone, for
strengthening
of the
abdominal
muscles, for
development
of firmer
abdomen.
Strengthening,
toning and
firming of
buttocks &
thighs.	Identical
Target population	It is to be used by
adults only.	It is to be used by
adults only.	Identical
Power source	100-240AC,
50/60Hz, 75VA	AC/DC Adaptor &
24V DC Ni MH
Rechargeable
Battery	Modified;
The modified device uses
an internal medical grade
Method of Line
Current Isolation	(a) AC Power supply
is converted to DC
Power supply
through a medical
grade PSU, which
has isolation of
2XMOPP (IEC60601-

Relative Humidity:
10% to 85% (non-
condensing) | Temperature:
+5°C to +45°C

Relative Humidity:
10% to 85% (non-
condensing) | Identical |

Basic Device Characteristics – Comparison with Predicate Device

6

7

8

9

Comparison

Output Specification – Comparion with Predicate Devcies

Characteristics	MODIFIED DEVICE	PREDICATE DEVICE	Comparison
	Torc Body (K192039)	Torc Body (K131291)
Output Waveform	Classic Vector	ABS-6	N/A
Waveform	Symmetrical Biphasic	Symmetrical Biphasic	Identical
Shape	Step Sine Wave	Square Wave	Modified;
The modified devices uses sinewave
Maximum Output
Voltage	51.6 Vpp @ 500Ω
(± 10%)
62.4 Vpp @ 2KΩ
(± 10%)
66 Vpp @ 10KΩ
(± 10%)	51 Vpp @ 500Ω
(± 10%)
63 Vpp @ 2KΩ
(± 10%)
66 Vpp @ 10KΩ
(± 10%)	Modified;
The difference between the devices at 500 and 2KΩ values is negligible.
Maximum Output
Current	103.2 mA pp @ 500 Ohm
31.2 mA pp @ 2K Ohm
6.6 mA pp @ 10K	102 mA pp @ 500 Ohm
31.5 mA pp @ 2K Ohm
6.6 mA pp @ 10K	Modified;
The difference between the devices at 500

Mode: Classic Vector

			sinewave
Maximum Output
Voltage	51.6 Vpp @ 500Ω
(± 10%)
62.4 Vpp @ 2KΩ
(± 10%)
66 Vpp @ 10KΩ
(± 10%)	51 Vpp @ 500Ω
(± 10%)
63 Vpp @ 2KΩ
(± 10%)
66 Vpp @ 10KΩ
(± 10%)	Modified;
The difference
between the two
devices at 500Ω
and 2KΩ values, is
negligible.
Maximum Output
Current	103.2 mA pp @ 500
Ohm
31.2 mA pp @ 2K
Ohm
6.6 mA pp @ 10K
Ohm	102 mA pp @ 500
Ohm
31.5 mA pp @ 2K
Ohm
6.6 mA pp @ 10K
Ohm	Modified;
The difference
between the two
devices at 500Ω
and 2KΩ values, is
negligible.
Pulse Width	124.7 μS (± 10%)
@500Ω	350 μS (± 10%)	Modified;
The pulse width is
less than the
predicate device,
however the
waveshape is
sinewave with
duty cycle of 50%,
which implies that
the strength of
the stimulation is
essentially the
			same in both
			devices.
Frequency	4010 Hz (± 10%)
@500Ω
Resultant: 1 – 100 Hz	99 Hz (± 10%)	Modified;
The pulse rate is
higher in the
modified device,
but due to the
interferential
effect the
resultant
frequency is only
1 – 100 Hz
(sweeping), which
is virtually
identical to the
predicate devcie
with frequency
(99 Hz).
For Interferential
modes only:
-Beat frequency	N/A	N/A	Identical
For multiphasic
Waveform

Symmetrical
Phases? | Yes | Yes | Identical |
| - Phase duration | 124.7 μS | 350 μS | Modified;
The phase
duration is less
than the predicate
device, however
the waveshape is
sinewave with
duty cycle of 50%,
which implies that
the strength of
the stimulation is
essentially the
same in both
devices. |
| Net charge | 0 μC @500Ω (Being
Biphasic in nature
the net charge would
be Zero) | 0 μC @500Ω (Being
Biphasic in nature
the net charge would
be Zero) | Identical |
| Maximum
Phase Charge | 6.435 μC | 35.7 μC | Modified; |
| | | | The phase charge
is less than the
predicate device,
however the
waveshape is
sinewave with
duty cycle of 50%,
which implies that
the strength of
the stimulation is
essentially the
same in both
devices. |
| Maximum
Current Density | 1.15 mA/cm²
*measured with 50 x 90mm
rectangular electrodes | 1.14 mA/cm²
*measured with 50 x 90mm
rectangular electrodes | Modified;

The difference
between the
values of both
devices is
negligible. |
| Maximum
Power Density | 0.0295 Watt/cm²
*measured with 50 x 90mm
rectangular electrodes | 0.0289 Watt/cm²
*measured with 50 x 90mm
rectangular electrodes | Modified;

Modified device

10

11

12

Mode: Power Sequence

13

Mode: Dynamic Rotation

| Characteristics | MODIFIED DEVICE
Torc Body (K192039) | PREDICATE DEVICE
Torc Body (K131291) | Comparison |
|-----------------|----------------------------------------|-----------------------------------------|------------|
| Output Waveform | Dynamic Rotation | ABS-6 | N/A |
| Waveform | Symmetrical Biphasic | Symmetrical
Biphasic | Identical |

14

Shape	Modulated Sine Wave	Square Wave	Modified;
Maximum Output
Voltage	51.2 Vpp @ 500Ω
(± 10%)
63.2 Vpp @ 2KΩ
(± 10%)
65.6 Vpp @ 10KΩ
(± 10%)	51 Vpp @ 500Ω
(± 10%)
63 Vpp @ 2KΩ
(± 10%)
66 Vpp @ 10KΩ
(± 10%)	Modified;
The difference
between the two
devices values at
different load
values is
negligible.
Maximum Output
Current	102.4 mA pp @ 500
Ohm
31.6 mA pp @ 2K
Ohm
6.56 mA pp @ 10K
Ohm	102 mA pp @ 500
Ohm
31.5 mA pp @ 2K
Ohm
6.6 mA pp @ 10K
Ohm	Modified;
The difference
between the two
devices values at
different load
values is
negligible
Pulse Width	124.9 μS (± 10%) @
500Ω	350 μS (± 10%)	Modified;
The pulse width is
less than the
predicate device,
however the
waveshape is
sinewave with
duty cycle of 50%,
which implies that
the strength of
the stimulation is
essentially the
same in both
devices.
Frequency	4002 Hz (± 10%) @
500Ω
Resultant: 1 – 100 Hz	99 Hz (± 10%)	Modified;
The pulse rate is
higher in the
modified device,
but due to the
interferential
effect the
resultant
frequency is only
			1 – 100 Hz
(sweeping), which
is virtually
identical to the
predicate devcie
with frequency
(99 Hz).
Beat frequency	NA	NA	Identical
For multiphasic
Waveform
Symmetrical
Phases?	Yes, Symmetrical
Biphasic	Yes, Symmetrical
Biphasic	Identical
Phase duration	124.9 μS (± 10%)	350 μS (± 10%)	Modified;
The phase
duration is less
than the predicate
device, however
the waveshape is
sinewave with
duty cycle of 50%,
which implies that
the strength of
the stimulation is
essentially the
same in both
devices.
Net charge	0 μC @500Ω (Being
Biphasic in nature the
net charge would be
Zero)	0 μC @500Ω (Being
Biphasic in nature
the net charge
would be Zero)	Identical
Maximum Phase
Charge	6.4 μC	35.7 μC	Modified;
The phase charge
is less than the
predicate device,
however the
waveshape is
sinewave with
duty cycle of 50%,
which implies that
the strength of
the stimulation is
essentially the
same in both
devices.
Maximum Current
density	1.14 mA/cm²
*measured with 50 x 90mm
rectangular electrodes	1.14 mA/cm²
*measured with 50 x 90mm
rectangular electrodes	Modified;
The difference
between the
values of both
devices is
negligible.
Maximum Power
Density	0.0291 Watts/cm²
*measured with 50 x 90mm
rectangular electrodes	0.0289 Watts/cm²
*measured with 50 x 90mm
rectangular electrodes	Modified;
The difference
between the
values of both
devices is
negligible.
Burst Mode
-Pulses Per Burst
-Burst Per second
-Burst Duration
-Duty Cycle	NA	NA	Identical
ON Time	NA	5.5 seconds	Modified;
Modified device
does not have ON
time.
OFF Time	NA	5.5 seconds	Modified;
Modified device
does not have OFF
time.
Additional Features	Sweep Frequency 1-
100 Hz	-	The modified
device has feature
of sweep
frequency.

15

16

Although there are minor differnces observed between the individual mode parameters of modified Torc Body and the predicate device, no difference found raised any questions regarding safety and effectiveness of the modified device. The primary change from the predicate Torc Body device to Torc Body Version 2.0 is that the new device model provides an internal power supply instead of a rechargeable battery; a user-friendly GUJ; and a wheeled console. We are also proposing to change the type of use from Over the Counter to Prescription.

There are no changes to the indications for use, fundamental scientific principles, performance specifications, or operation of the device.

17

User-Friendly GUI: The modified Torc Body device has a larger touch screen LCD, which gives a wide-angle view that significantly facilitates the use of the device.

Power Supply: The modified Torc Body device is equipped with an internal medical grade power supply, instead of an AC/DC adaptor and rechargeable battery (predicate device). Testing under voluntary standards has been carried out to make sure the power supply is safe and there are no new risks with this change.

Wheeled Console: The Torc Body has been upgraded to a modern, sleek, wheeled console which allows clinicians to navigate and operate the device effortlessly.

Prescription Device: As a manufacturer, we understand that the modified Torc Body device is based on the same technology and intended for the same use as its predicate device and that the modifications will not affect safety and effectiveness. However, as we intend to market this device to clinicians, we propose making it a prescription device.

The fundamental scientific technology is not changed in the modified device, and the change is solely considered for ease of use to the clinician. The modified device generates the same stimulation to contract the muscles rhythmically to achieve the intended use of strengthening, firming, and toning the muscles of the abdomen, thighs, and buttocks. The clinician can increase or decrease the intensity as per the desired stimulation.

While redesigning the Torc Body, complete care and considerable measures have been taken to retain its safety and effectiveness. The modified Torc Body device complies with voluntary standards, hence the modified device is substantially equivalent to the predicate device.

Non-Clinical Testing

The following bench testing was conducted for design and performance elements deemed appropriate to demonstrate equivalence to the previously cleared Torc Body device. The modified device Torc Body met the predetermined acceptance criteria ensuring substantial equivalence to the previously cleared device. No new safety or performance issues were raised during testing.

Non-Clinical Bench Testing:

Reliability Testing
Compliance Testing (IEC60601-1, IEC60601-1-2
Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)
Quality System Regulation (21CFR820)
Application of usability engineering to medical devices (IEC 62366)
Application of risk management to medical devices (ISO 14971)
Symbols to be used with medical device labels, labelling and information to be supplied (ISO 15233)
Biological evaluation of medical devices (ISO 10993-1)

18

CONCLUSION

The information and testing presented in this traditional 510(k) demonstrate that the modified Torc Body device performs as designed and is substantially equivalent to the predicate device (K131291). The changes made do not affect the safety and effectiveness of the device.