Who is the manufacturer of Torc Body?

Johari Digital Healthcare Limited filed the 510(k) submission for Torc Body (K192039).

What is the FDA product code for Torc Body?

NGX. It is classified under 21 CFR 890.5850 as a Class 2 device in the Physical Medicine panel.

What is the regulatory pathway for Torc Body?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like Torc Body?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

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

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.

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)

{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) | | |-----------------------------------------------------------------------------------|----------------------------------------------------------------------------------| | <div> ☑ Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </div> | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {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- 1) (b) Isolation thru transformer in between device and patient | (a) AC Power supply is converted to DC Power supply through Adaptor, which uses a transformer in between the Low and High voltage sides. Hence there is insulation of mains from Circuitry. (b) The device operates on Ni-Mh rechargeable battery | power supply, in place of AC/DC adaptor and rechargeable battery used in the predicate device. The internal power supply complies with all necessary voluntary standards. Modified; The new version of Torc Body has 2XMOPP level isolation as required by the IEC standards. | | Patient Leakage Current Normal condition Single Fault condition | Normal condition = less than $100\mu A$ Single fault condition = less than $300\mu A$ | Normal condition = less than $100\mu A$ Single fault condition = less than $300\mu A$ | Identical | | Components | Main unit, 8 self adhesive electrodes , 4 electrode lead wires, , 1 AC Power Cord | Main unit, 8 electrodes, 4 electrode lead wires, 6 elastic belts (2 large, 2 medium, 2 small), 1 AC Adapter. | Modified; The modified device has an internal medical grade power supply with an AC power cord; the predicate device has a rechargeable battery with an AC adapter. | | Display | 12" LCD | 5.7" LCD | Modified; | | | | | Modified for better visual which gives a wide view angle. | | Number of Output Modes | 03 (Classic Vector, Power Sequence, Dynamic Rotation) | 03 (ABS, BTS, CVL) | Modified; Name of the modes (Classic Vector, Power Sequence, Dynamic Rotation) has been modified for a clear understanding of the clinician. | | Number of Output Channels | 2 (Two) | 2 (Two) | Identical | | Synchronous or Alternating? | Synchronous (a) Output 1 to 2 are completely isolated. Only power supply and ground are common | Synchronous (a) Output 1 to 2 are completely isolated. Only power supply and ground are common | Identical | | Method of Channel Isolation | Transformer | Transformer | Identical | | Regulated Current or Regulated Voltage | Tran conductance | Tran conductance | Identical | | Software/Firmware/ Microprocessors Controls? | YES | YES | Identical | | Automatic Overload Trip? | YES | YES | Identical | | Automatic No-Load Trip | NO | NO | Identical | | Automatic Shut off? | YES | YES | Identical | | Patient Override Control? | YES | YES | Identical | | Indicator Display: On/Off Status? | YES | YES | Identical | | Low Battery? | N/A | YES | Modified; The modified device does not have a battery and, therefore, does not have | | | | | a battery indicator display. | | Voltage/Current Level? | YES | YES | Identical | | Timer Range (minutes) | 1 – 60 Minutes In step of 1 minute | 1 – 60 Minutes In step of 1 minute | Identical | | Compliance with Voluntary Standards? | YES IEC 60601-1, IEC 60601-1- 2,IEC60601-2-10, and ISO14971 | YES IEC 60601-1, IEC 60601-1- 2,IEC60601-2-10, and ISO14971 | Identical | | Compliance With 21 CFR 898 | YES, the electrode cable can never be plugged in the AC socket, not even accidentally | YES, the electrode cable can never be plugged in the AC socket, not even accidentally | Identical | | Weight | 32.66 Kgs | 3.0 KG | Modified; The modified device has been upgraded to a wheeled console. | | Dimension (L X B X H) | 14″(L) X 17.5″ (W) X 40″(H) | 8.2″(L) x 6.0″ (W) x 4.0" (H) | Modified; The modified device has been upgraded to a wheeled console. | | Housing Material and construction | ABS Plastic Body | ABS Plastic Body | Identical | | Operating Temperature | Temperature: +15°C to +35°C | Temperature: +15°C to +35°C | Identical | | | Relative Humidity: 30 % to 75 % (non- condensing) Barometric | Relative Humidity: 30 % to 75 % (non- condensing) Barometric | | | | pressure: 700 hPa to 1060 hPa | pressure: 700 hPa to 1060 hPa | | | Transport and storage environment | Temperature: +5°C to +45°C 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; The difference between the values of both devices is negligible. | | Burst Mode -Pulses Per Burst -Burst Per second -Burst Duration -Duty Cycle | N/A | N/A | Identical | | ON Time | N/A | 5.5 seconds | Modified; Modified device does not have ON time. | | OFF Time | N/A | 5.5 seconds | Modified; Modified device does not have OFF time. | | Additional Features | Sweep Frequency 1- 100 Hz | N/A | The modified device has feature of sweep frequency | | Characteristics | MODIFIED DEVICE Torc Body (K192039) | PREDICATE DEVICE 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 Voltage | 50.8 Vpp @ 500Ω (± 10%) 64 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 values of both devices at different is negligible. | | Maximum Output Current | 101.6 mA pp @ 500 Ohm 32 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 values of both devices is negligible. | | Pulse Width | 350 μS (± 10%) @ 500Ω | 350 μS (± 10%) | Identical | | Frequency | 99.91 Hz (± 10%) @ 500Ω | 99 Hz (± 10%) | Modified; The difference between the values of both devices is negligible. | | Beat frequency For multiphasic Waveform Symmetrical Phases? | N/A | N/A | Identical | | Phase duration | Yes, Symmetrical Biphasic 350 μS (± 10%) | Yes, Symmetrical Biphasic 350 μS (± 10%) | Identical | | 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 | 35.56 μC @ 500 Ω Load | 35.7 μC @ 500 Ω Load | Modified; | | Maximum Current density | 1.13 mA/cm² *measured with 50 x 90mm rectangular electrodes | 1.14 mA/cm² *measured with 50 x 90mm rectangular electrodes | The difference between the values of both devices is negligible. Modified; | | Maximum Power Density | 0.0287 Watt/cm² *measured with 50 x 90mm rectangular electrodes | 0.0289 Watt/cm² *measured with 50 x 90mm rectangular electrodes | The difference between the values of both devices is negligible. Modified; | | Burst Mode -Pulses Per Burst -Burst Per second -Burst Duration -Duty Cycle | N/A | N/A | Identical | | ON Time | 6 seconds | 5.5 seconds | Modified; The difference between the values of both devices is virtually identical. | | OFF Time | 4 seconds | 5.5 seconds | Modified; The difference between the values of both devices is virtually identical. | | Additional Features | | | Identical. | {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…

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