Torc Body

K192039 · Johari Digital Healthcare Limited · NGX · Mar 29, 2020 · Physical Medicine

Device Facts

• Record ID: K192039
• Device Name: Torc Body
• Applicant: Johari Digital Healthcare Limited
• Product Code: NGX · Physical Medicine
• Decision Date: Mar 29, 2020
• Decision: SESE
• Submission Type: Traditional
• 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 powered muscle stimulator used by clinicians in a clinical setting. The device delivers electrical stimulation via self-adhesive electrodes to contract muscles rhythmically. It features three modes: Classic Vector (warm-up/circulation), Power Sequence (strength/endurance), and Dynamic Rotation (toning/firming). The device is housed in a wheeled console with a 12-inch GUI for clinician operation. Clinicians adjust stimulation intensity to achieve muscle strengthening, firming, and toning. The device operates on an internal medical-grade power supply. By inducing rhythmic muscle contractions, the device assists in improving muscle tone and firmness, providing a non-invasive method for muscle conditioning.

Clinical Evidence

Bench testing only. Performance data demonstrated compliance with IEC 60601-1, IEC 60601-1-2, IEC 60601-2-10, ISO 14971, ISO 13485, IEC 62366, ISO 15233, and ISO 10993-1. Testing confirmed the modified device meets predetermined acceptance criteria for reliability and safety.

Technological Characteristics

Powered muscle stimulator; ABS plastic housing; 12-inch LCD GUI; internal medical-grade power supply (100-240VAC); 2 output channels; symmetrical biphasic waveform; transformer-based channel isolation; 2XMOPP isolation; prescription-use; wheeled console form factor. Complies with IEC 60601-1, IEC 60601-1-2, IEC 60601-2-10, and ISO 14971.

Indications for Use

Indicated for adults for improvement of abdominal tone, strengthening of abdominal muscles, development of firmer abdomen, 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

• Torc Body (K131291)

Submission Summary (Full Text)

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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

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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 ([e-mail]) or phone [phone] 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

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# 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) | |
|-----------------------------------------------------------------------------------|----------------------------------------------------------------------------------|
| <div> <span> ☑ Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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

| Device Name | Torc Body |
|-------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------|
| Submitters name/<br>contact details | Nisha Johari<br>Johari Digital Healthcare Ltd<br>G-582, 584 EPIP, Boranada,<br>Jodhpur - India - 342008<br>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,<br>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,<br>Stimulator, Muscle, Powered, For Muscle Conditioning |
| 510(K) No | K131291 |
| Address and Registration | Johari Digital Healthcare Ltd<br>G-582, 584 EPIP, Boranada,<br>Jodhpur - India - 342008 |
| Contact Person: | Nisha Johari |
| Contact Number: | [phone] |
| FDA Registration | 8040537 |

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#### 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.

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### 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,<br>Model | Torc Body | Torc Body | Design revision updated<br>to V2.0 |
| Manufactured For | 7E LLC | 7E LLC | Identical |
| Manufactured By | Johari Digital<br>Healthcare Ltd. | Johari Digital<br>Healthcare Ltd. | Identical |
| Classification Name | Powered muscle<br>stimulator | Powered muscle<br>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;<br>We intend to market this<br>device to clinicians and<br>propose making it a<br>prescription device. |
| Indication for use | Improvement of<br>abdominal tone,<br>for strengthening<br>of the abdominal<br>muscles, for<br>development of<br>firmer abdomen.<br>Strengthening,<br>toning and<br>firming of<br>buttocks &<br>thighs. | Improvement<br>of abdominal<br>tone, for<br>strengthening<br>of the<br>abdominal<br>muscles, for<br>development<br>of firmer<br>abdomen.<br>Strengthening,<br>toning and<br>firming of<br>buttocks &<br>thighs. | Identical |
| Target population | It is to be used by<br>adults only. | It is to be used by<br>adults only. | Identical |
| Power source | 100-240AC,<br>50/60Hz, 75VA | AC/DC Adaptor &<br>24V DC Ni MH<br>Rechargeable<br>Battery | Modified;<br>The modified device uses<br>an internal medical grade |
| Method of Line<br>Current Isolation | (a) AC Power supply<br>is converted to DC<br>Power supply<br>through a medical<br>grade PSU, which<br>has isolation of<br>2XMOPP (IEC60601-<br>1)<br>(b) Isolation thru<br>transformer in<br>between device and<br>patient | (a) AC Power<br>supply is<br>converted to DC<br>Power supply<br>through Adaptor,<br>which uses a<br>transformer in<br>between the Low<br>and High voltage<br>sides. Hence there<br>is insulation of<br>mains from<br>Circuitry.<br>(b) The device<br>operates on Ni-Mh<br>rechargeable<br>battery | power supply, in place of<br>AC/DC adaptor and<br>rechargeable battery<br>used in the predicate<br>device. The internal<br>power supply complies<br>with all necessary<br>voluntary standards.<br>Modified;<br>The new version of Torc<br>Body has 2XMOPP level<br>isolation as required by<br>the IEC standards. |
| Patient Leakage<br>Current<br>Normal condition<br>Single Fault<br>condition | Normal condition =<br>less than<br>$100\mu A$<br>Single fault<br>condition = less than<br>$300\mu A$ | Normal condition<br>= less than $100\mu A$<br>Single fault<br>condition = less<br>than $300\mu A$ | Identical |
| Components | Main unit, 8 self<br>adhesive electrodes<br>, 4 electrode lead<br>wires, , 1 AC Power<br>Cord | Main unit, 8<br>electrodes, 4<br>electrode lead<br>wires, 6 elastic<br>belts (2 large, 2<br>medium, 2 small),<br>1 AC Adapter. | Modified;<br>The modified device has<br>an internal medical grade<br>power supply with an AC<br>power cord; the<br>predicate device has a<br>rechargeable battery<br>with an AC adapter. |
| Display | 12" LCD | 5.7" LCD | Modified; |
| | | | Modified for better visual<br>which gives a wide view<br>angle. |
| Number of Output<br>Modes | 03<br>(Classic Vector,<br>Power Sequence,<br>Dynamic Rotation) | 03<br>(ABS, BTS, CVL) | Modified;<br>Name of the modes<br>(Classic Vector, Power<br>Sequence, Dynamic<br>Rotation) has been<br>modified for a clear<br>understanding of the<br>clinician. |
| Number of Output<br>Channels | 2 (Two) | 2 (Two) | Identical |
| Synchronous or<br>Alternating? | Synchronous<br>(a) Output 1 to 2 are<br>completely isolated.<br>Only power supply<br>and ground are<br>common | Synchronous<br>(a) Output 1 to 2<br>are completely<br>isolated. Only<br>power supply and<br>ground are<br>common | Identical |
| Method of Channel<br>Isolation | Transformer | Transformer | Identical |
| Regulated Current<br>or<br>Regulated Voltage | Tran conductance | Tran conductance | Identical |
| Software/Firmware/<br>Microprocessors<br>Controls? | YES | YES | Identical |
| Automatic Overload<br>Trip? | YES | YES | Identical |
| Automatic No-Load<br>Trip | NO | NO | Identical |
| Automatic Shut off? | YES | YES | Identical |
| Patient Override<br>Control? | YES | YES | Identical |
| Indicator Display:<br>On/Off Status? | YES | YES | Identical |
| Low Battery? | N/A | YES | Modified;<br>The modified device does<br>not have a battery and,<br>therefore, does not have |
| | | | a battery indicator<br>display. |
| Voltage/Current<br>Level? | YES | YES | Identical |
| Timer Range<br>(minutes) | 1 – 60 Minutes<br>In step of 1 minute | 1 – 60 Minutes<br>In step of 1<br>minute | Identical |
| Compliance with<br>Voluntary<br>Standards? | YES<br>IEC 60601-1, IEC<br>60601-1-<br>2,IEC60601-2-10,<br>and ISO14971 | YES<br>IEC 60601-1, IEC<br>60601-1-<br>2,IEC60601-2-10,<br>and ISO14971 | Identical |
| Compliance With 21<br>CFR 898 | YES, the electrode<br>cable can never be<br>plugged in the AC<br>socket, not even<br>accidentally | YES, the electrode<br>cable can never be<br>plugged in the AC<br>socket, not even<br>accidentally | Identical |
| Weight | 32.66 Kgs | 3.0 KG | Modified;<br>The modified device has<br>been upgraded to a<br>wheeled console. |
| Dimension<br>(L X B X H) | 14″(L) X 17.5″ (W) X<br>40″(H) | 8.2″(L) x 6.0″ (W) x<br>4.0" (H) | Modified;<br>The modified device has<br>been upgraded to a<br>wheeled console. |
| Housing Material<br>and construction | ABS Plastic Body | ABS Plastic Body | Identical |
| Operating<br>Temperature | Temperature: +15°C<br>to +35°C | Temperature:<br>+15°C to +35°C | Identical |
| | Relative Humidity:<br>30 % to 75 % (non-<br>condensing)<br>Barometric | Relative Humidity:<br>30 % to 75 % (non-<br>condensing)<br>Barometric | |
| | pressure:<br>700 hPa to 1060 hPa | pressure:<br>700 hPa to 1060 hPa | |
| Transport and<br>storage<br>environment | Temperature: +5°C<br>to +45°C<br><br>Relative Humidity:<br>10% to 85% (non-<br>condensing) | Temperature:<br>+5°C to +45°C<br><br>Relative Humidity:<br>10% to 85% (non-<br>condensing) | Identical |

## Basic Device Characteristics – Comparison with Predicate Device

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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;<br>The modified devices uses sinewave |
| Maximum Output<br>Voltage | 51.6 Vpp @ 500Ω<br>(± 10%)<br>62.4 Vpp @ 2KΩ<br>(± 10%)<br>66 Vpp @ 10KΩ<br>(± 10%) | 51 Vpp @ 500Ω<br>(± 10%)<br>63 Vpp @ 2KΩ<br>(± 10%)<br>66 Vpp @ 10KΩ<br>(± 10%) | Modified;<br>The difference between the devices at 500 and 2KΩ values is negligible. |
| Maximum Output<br>Current | 103.2 mA pp @ 500 Ohm<br>31.2 mA pp @ 2K Ohm<br>6.6 mA pp @ 10K | 102 mA pp @ 500 Ohm<br>31.5 mA pp @ 2K Ohm<br>6.6 mA pp @ 10K | Modified;<br>The difference between the devices at 500 |

# Mode: Classic Vector

| | | | sinewave |
|----------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------|---------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Maximum Output<br>Voltage | 51.6 Vpp @ 500Ω<br>(± 10%)<br>62.4 Vpp @ 2KΩ<br>(± 10%)<br>66 Vpp @ 10KΩ<br>(± 10%) | 51 Vpp @ 500Ω<br>(± 10%)<br>63 Vpp @ 2KΩ<br>(± 10%)<br>66 Vpp @ 10KΩ<br>(± 10%) | Modified;<br>The difference<br>between the two<br>devices at 500Ω<br>and 2KΩ values, is<br>negligible. |
| Maximum Output<br>Current | 103.2 mA pp @ 500<br>Ohm<br>31.2 mA pp @ 2K<br>Ohm<br>6.6 mA pp @ 10K<br>Ohm | 102 mA pp @ 500<br>Ohm<br>31.5 mA pp @ 2K<br>Ohm<br>6.6 mA pp @ 10K<br>Ohm | Modified;<br>The difference<br>between the two<br>devices at 500Ω<br>and 2KΩ values, is<br>negligible. |
| Pulse Width | 124.7 μS (± 10%)<br>@500Ω | 350 μS (± 10%) | Modified;<br>The pulse width is<br>less than the<br>predicate device,<br>however the<br>waveshape is<br>sinewave with<br>duty cycle of 50%,<br>which implies that<br>the strength of<br>the stimulation is<br>essentially the |
| | | | same in both |
| | | | devices. |
| Frequency | 4010 Hz (± 10%)<br>@500Ω<br>Resultant: 1 – 100 Hz | 99 Hz (± 10%) | Modified;<br>The pulse rate is<br>higher in the<br>modified device,<br>but due to the<br>interferential<br>effect the<br>resultant<br>frequency is only<br>1 – 100 Hz<br>(sweeping), which<br>is virtually<br>identical to the<br>predicate devcie<br>with frequency<br>(99 Hz). |
| For Interferential<br>modes only:<br>-Beat frequency | N/A | N/A | Identical |
| For multiphasic<br>Waveform<br>- Symmetrical<br>Phases? | Yes | Yes | Identical |
| - Phase duration | 124.7 μS | 350 μS | Modified;<br>The phase<br>duration is less<br>than the predicate<br>device, however<br>the waveshape is<br>sinewave with<br>duty cycle of 50%,<br>which implies that<br>the strength of<br>the stimulation is<br>essentially the<br>same in both<br>devices. |
| Net charge | 0 μC @500Ω (Being<br>Biphasic in nature<br>the net charge would<br>be Zero) | 0 μC @500Ω (Being<br>Biphasic in nature<br>the net charge would<br>be Zero) | Identical |
| Maximum<br>Phase Charge | 6.435 μC | 35.7 μC | Modified; |
| | | | The phase charge<br>is less than the<br>predicate device,<br>however the<br>waveshape is<br>sinewave with<br>duty cycle of 50%,<br>which implies that<br>the strength of<br>the stimulation is<br>essentially the<br>same in both<br>devices. |
| Maximum<br>Current Density | 1.15 mA/cm²<br>*measured with 50 x 90mm<br>rectangular electrodes | 1.14 mA/cm²<br>*measured with 50 x 90mm<br>rectangular electrodes | Modified;<br><br>The difference<br>between the<br>values of both<br>devices is<br>negligible. |
| Maximum<br>Power Density | 0.0295 Watt/cm²<br>*measured with 50 x 90mm<br>rectangular electrodes | 0.0289 Watt/cm²<br>*measured with 50 x 90mm<br>rectangular electrodes | Modified;<br><br>The difference<br>between the<br>values of both<br>devices is<br>negligible. |
| Burst Mode<br>-Pulses Per Burst<br>-Burst Per second<br>-Burst Duration<br>-Duty Cycle | N/A | N/A | Identical |
| ON Time | N/A | 5.5 seconds | Modified;<br><br>Modified device<br>does not have ON<br>time. |
| OFF Time | N/A | 5.5 seconds | Modified;<br><br>Modified device<br><br>does not have OFF<br>time. |
| Additional Features | Sweep Frequency 1-<br>100 Hz | N/A | The modified<br>device has feature<br>of sweep<br>frequency |
| Characteristics | MODIFIED DEVICE<br>Torc Body (K192039) | PREDICATE DEVICE<br>Torc Body (K131291) | Comparison |
| Output Waveform | Power Sequence | ABS-6 | N/A |
| Waveform | Symmetrical Biphasic | Symmetrical Biphasic | Identical |
| Shape | Square wave | Square Wave | Identical |
| Maximum Output<br>Voltage | 50.8 Vpp @ 500Ω<br>(± 10%)<br>64 Vpp @ 2KΩ<br>(± 10%)<br>65.6 Vpp @ 10KΩ<br>(± 10%) | 51 Vpp @ 500Ω<br>(± 10%)<br>63 Vpp @ 2KΩ<br>(± 10%)<br>66 Vpp @ 10KΩ<br>(± 10%) | Modified;<br>The difference<br>between the<br>values of both<br>devices at<br>different is<br>negligible. |
| Maximum Output<br>Current | 101.6 mA pp @ 500<br>Ohm<br>32 mA pp @ 2K Ohm<br>6.56 mA pp @ 10K<br>Ohm | 102 mA pp @ 500<br>Ohm<br>31.5 mA pp @ 2K<br>Ohm<br>6.6 mA pp @ 10K<br>Ohm | Modified;<br>The difference<br>between the<br>values of both<br>devices is<br>negligible. |
| Pulse Width | 350 μS (± 10%) @<br>500Ω | 350 μS (± 10%) | Identical |
| Frequency | 99.91 Hz (± 10%) @<br>500Ω | 99 Hz (± 10%) | Modified;<br>The difference<br>between the<br>values of both<br>devices is<br>negligible. |
| Beat frequency<br>For multiphasic<br>Waveform<br>Symmetrical Phases? | N/A | N/A | Identical |
| Phase duration | Yes, Symmetrical<br>Biphasic<br>350 μS (± 10%) | Yes, Symmetrical<br>Biphasic<br>350 μS (± 10%) | Identical |
| Net charge | 0 μC @500Ω (Being<br>Biphasic in nature<br>the net charge would<br>be Zero) | 0 μC @500Ω (Being<br>Biphasic in nature<br>the net charge would<br>be Zero) | Identical |
| Maximum Phase<br>Charge | 35.56 μC @ 500 Ω<br>Load | 35.7 μC @ 500 Ω<br>Load | Modified; |
| Maximum Current<br>density | 1.13 mA/cm²<br>*measured with 50 x 90mm<br>rectangular electrodes | 1.14 mA/cm²<br>*measured with 50 x 90mm<br>rectangular electrodes | The difference<br>between the<br>values of both<br>devices is<br>negligible.<br>Modified; |
| Maximum Power<br>Density | 0.0287 Watt/cm²<br>*measured with 50 x 90mm<br>rectangular electrodes | 0.0289 Watt/cm²<br>*measured with 50 x 90mm<br>rectangular electrodes | The difference<br>between the<br>values of both<br>devices is<br>negligible.<br>Modified; |
| Burst Mode<br>-Pulses Per Burst<br>-Burst Per second<br>-Burst Duration<br>-Duty Cycle | N/A | N/A | Identical |
| ON Time | 6 seconds | 5.5 seconds | Modified;<br>The difference<br>between the<br>values of both<br>devices is virtually<br>identical. |
| OFF Time | 4 seconds | 5.5 seconds | Modified;<br>The difference<br>between the<br>values of both<br>devices is virtually<br>identical. |
| Additional Features | | | Identical. |

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## Mode: Power Sequence

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# Mode: Dynamic Rotation

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

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| Shape | Modulated Sine Wave | Square Wave | Modified; |
|----------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------|---------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Maximum Output<br>Voltage | 51.2 Vpp @ 500Ω<br>(± 10%)<br>63.2 Vpp @ 2KΩ<br>(± 10%)<br>65.6 Vpp @ 10KΩ<br>(± 10%) | 51 Vpp @ 500Ω<br>(± 10%)<br>63 Vpp @ 2KΩ<br>(± 10%)<br>66 Vpp @ 10KΩ<br>(± 10%) | Modified;<br>The difference<br>between the two<br>devices values at<br>different load<br>values is<br>negligible. |
| Maximum Output<br>Current | 102.4 mA pp @ 500<br>Ohm<br>31.6 mA pp @ 2K<br>Ohm<br>6.56 mA pp @ 10K<br>Ohm | 102 mA pp @ 500<br>Ohm<br>31.5 mA pp @ 2K<br>Ohm<br>6.6 mA pp @ 10K<br>Ohm | Modified;<br>The difference<br>between the two<br>devices values at<br>different load<br>values is<br>negligible |
| Pulse Width | 124.9 μS (± 10%) @<br>500Ω | 350 μS (± 10%) | Modified;<br>The pulse width is<br>less than the<br>predicate device,<br>however the<br>waveshape is<br>sinewave with<br>duty cycle of 50%,<br>which implies that<br>the strength of<br>the stimulation is<br>essentially the<br>same in both<br>devices. |
| Frequency | 4002 Hz (± 10%) @<br>500Ω<br>Resultant: 1 – 100 Hz | 99 Hz (± 10%) | Modified;<br>The pulse rate is<br>higher in the<br>modified device,<br>but due to the<br>interferential<br>effect the<br>resultant<br>frequency is only |
| | | | 1 – 100 Hz<br>(sweeping), which<br>is virtually<br>identical to the<br>predicate devcie<br>with frequency<br>(99 Hz). |
| Beat frequency | NA | NA | Identical |
| For multiphasic<br>Waveform<br>Symmetrical<br>Phases? | Yes, Symmetrical<br>Biphasic…