truSculpt flex
Device Facts
| Record ID | K212866 |
|---|---|
| Device Name | truSculpt flex |
| Applicant | Johari Digital Healthcare Limited |
| Product Code | NGX · Physical Medicine |
| Decision Date | Dec 3, 2022 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 890.5850 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
truSculpt flex 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
Electrical muscle stimulator; delivers electrical impulses via electrodes on skin to induce rhythmic muscle contractions. System comprises console with touchscreen and eight handpiece pairs; uses disposable hydrogel pads and reusable silicone belts for attachment. Clinician selects treatment mode (PREP, TONE, SCULPT) and intensity; device provides targeted stimulation to abdomen, thighs, and buttocks. Used in clinical settings by professionals to improve muscle tone and strength. Output intensity is adjustable by clinician. Benefits include non-invasive muscle conditioning.
Clinical Evidence
Bench testing only. Performance data demonstrated equivalence to predicate device. Testing included reliability, electrical safety (IEC 60601-1), electromagnetic compatibility (IEC 60601-1-2), usability engineering (IEC 62366), risk management (ISO 14971), and biocompatibility (ISO 10993-1).
Technological Characteristics
Powered muscle stimulator; 100-240AC power source; 4 output channels; symmetrical biphasic waveform. Materials: ABS plastic housing, stainless steel electrodes, hydrogel pads, silicone belts. Connectivity: Standalone console with 12" LCD touchscreen. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-10, ISO 14971. Features: Automatic overload trip, automatic shut-off, patient override control.
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 (K192039)
Submission Summary (Full Text)
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December 3, 2022
Johari Digital Healthcare Limited Pooja Johari Founder and Director Marketing G-582, 584 EPIP, Boranda Jodhpur, Rajasthan 342012 India
Re: K212866
Trade/Device Name: truSculpt flex Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: NGX Dated: October 28, 2022 Received: November 4, 2022
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
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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 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 medical devices and radiation-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,
# Heather L. Dean -S
Heather Dean, Ph.D. Assistant Director, Acute Injury Devices Team 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) K212866
Device Name truSculpt flex
Indications for Use (Describe)
truSculpt flex 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)
| <span style="font-size: 10px;"> <svg height="15" width="15"> <rect fill="none" height="15" stroke="black" width="15" x="0" y="0"></rect> <line stroke="black" x1="2" x2="13" y1="2" y2="13"></line> <line stroke="black" x1="13" x2="2" y1="2" y2="13"></line> </svg> </span> Prescription Use (Part 21 CFR 801 Subpart D) |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| <span style="font-size: 10px;"> <svg height="15" width="15"> <rect fill="none" height="15" stroke="black" width="15" x="0" y="0"></rect> </svg> </span> Over-The-Counter Use (21 CFR 801 Subpart C) |
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## 510 (k) Summary
| Device Name | truSculpt flex muscle stimulator |
|-------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|
| Submitters name/<br>contact details | Nisha Johari<br>Johari Digital Healthcare Ltd<br>G-582- 584 EPIP, Boranada,<br>Jodhpur – India – 342012<br>Contact number: + 91-9829954228 |
| Summary<br>Preparation Date | 28-Oct-2022 |
| Device Trade Name | truSculpt flex |
| Device / Proprietary<br>Name | truSculpt flex |
| Common Name | Stimulator, Muscle, Powered, for Muscle Conditioning |
| Classification Name | Powered Muscle Stimulator,<br>Stimulator, Muscle, Powered, For Muscle Conditioning |
| Classification<br>Regulation | 21 CFR 890.5850, Class II |
| Classification<br>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 | K192039 |
| Address and<br>Registration | Johari Digital Healthcare Ltd<br>G-582, 584 EPIP, Boranada,<br>Jodhpur – India – 342012 |
| Contact Person: | Nisha Johari |
| FDA Registration | 8040537 |
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#### Device Description
truSculpt flex is an electrical muscle stimulator, which generates electrical impulses that are delivered through electrodes on the skin in direct proximity to the muscles to be stimulated. The device contracts muscles rhythmically to achieve the intended use of strengthening, firming, and toning the muscles of the abdomen, thighs, and buttocks.
truSculpt flex consists of a console with a touchscreen control panel and eight handpiece pairs. All system functions are controlled through the console. During a treatment session, one or more handpiece pairs are secured to the patient using disposable hydrogel pads and transparent silicone belts, and electrical stimulation is delivered to the treatment area at the selected treatment mode and intensity.
The fundamental scientific technology has not changed in the modified device. Changes are solely considered for ease of use for the clinicians. 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 device, complete care and considerable measures have been taken to retain its safety and effectiveness. The truSculpt flex device complies with voluntary standards.
The modified device, as described in this submission, is an upgrade from its previous version. Modifications include the addition of two outputs; change in electrode size and type; addition of adhesive hydrogel pads and reusable silicone belts; and renaming of treatment modes.
With respect to the previously cleared device, the modified device has two treatment types:
- > Classic In Classic mode, the treatment duration is 45 minutes.
- A flex+ - In flex+ mode, the treatment duration is 15 minutes.
For ease of use and operation for the clinicians, we have 3 modes (suggestive):
- . PREP mode creates a twisting motion to warm up and stretch the muscles and to slowly build a tolerance to muscle contractions. PREP mode is available for Classic treatments only.
Image /page/4/Picture/13 description: The image shows a diagram of a muscle being stimulated by two electrical devices. The devices are labeled with the numbers 1 and 2. The muscle is shown in a reddish-brown color, and the electrical stimulation is shown as yellow beams emanating from the devices. The devices are connected to the muscle by wires.
Fig:- Prep Mode
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• TONE mode contracts the muscles, holds it, and then relaxes to increase strength and muscle endurance. TONE mode is available for Classic and flex+ treatments.
Image /page/5/Picture/3 description: The image shows a diagram of a muscle stimulation device. The device consists of two white pads with yellow tops, labeled "1" and "2", placed on a brown surface. Yellow beams are shown emanating from the pads, targeting a muscle underneath. The pads are connected to wires, with a red wire attached to pad "1" and a black wire attached to pad "2".
#### Fig:- Tone Mode
• SCULPT mode uses fast, sequential contractions of the muscles which leads to toning and firming. SCULPT mode is available for Classic and flex+ treatments
Image /page/5/Picture/6 description: The image shows a medical device used for muscle stimulation. Two white devices with yellow labels marked "1" and "2" are positioned above a muscle. Yellow beams are emitted from the devices, targeting the muscle below. The setup suggests a therapeutic or diagnostic application involving targeted muscle stimulation.
Fig:- Sculpt Mode
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#### truSculpt flex in action- Interaction with patient
The device contracts muscles rhythmically to achieve the intended use of strengthening, firming, and toning the muscles of the abdomen, thighs, and buttocks.
Image /page/6/Picture/4 description: The image shows a person lying down with electrodes attached to their legs and abdomen. The electrodes are connected to wires that run to a machine in the background. The electrodes are placed on the person's skin with a clear plastic sheet. The electrodes are numbered 2, 3, 5, 6, and others.
#### Where
- 1. Reusable silicone belts (cummerbunds)
- 2. Electrodes ( Handpiece )
- 3. Adhesive hydrogel pads
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 device, complete care and considerable measures have been taken to retain its safety and effectiveness. The truSculpt flex device complies with voluntary standards.
#### Intended Use
truSculpt flex 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 a 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 , K192039).
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## Comparison of Technological Characteristics
A comparison given below identifies all the changes between the modified and the predicate device:
| Basic Device Characteristics – Comparison with Predicate Device | | | |
|-----------------------------------------------------------------|--|--|--|
| | | | |
| Device Features | Modified device | Predicate Device | Comparison | | |
|----------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------|-----------|
| 510(K) Number | K212866 | K192039 | N/A | | |
| Device Name, Model | truSculpt flex | Torc Body | Design revision updated | | |
| Manufactured For | 7e Wellness Corporation | 7e Wellness Corporation | 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 | Prescription | Identical | | |
| 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 | 100-240AC, 50/60Hz, 75VA | Identical | | |
| 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)<br>(b) Isolation thru transformer between device and patient | (a) AC Power supply is converted to DC Power supply through a medical-grade PSU, which has isolation of 2XMOPP (IEC60601-1)<br>(b) Isolation thru transformer between device and patient | Identical | | |
| Device Features | Modified device | Predicate Device | Comparison | | |
| Patient Leakage<br>Current<br>Normal condition | Normal condition = less<br>than<br>100μΑ | Normal condition = less<br>than<br>100μΑ | Identical | | |
| Single Fault<br>condition | Single fault condition =<br>less than 300μΑ | Single fault condition = less<br>than 300μA | | | |
| Components | Main unit,<br>8 Stainless steel reusable<br>electrodes pairs (16<br>electrodes)<br>4 electrode lead wires<br>1 AC Power Cord<br>4 Hydrogel pads<br>2 reusable silicone belts<br>(cummerbunds) | Main unit,<br>8 self adhesive electrodes ,<br>4 electrode lead wires,<br>1 AC Power Cord | Modified;<br>-The modified<br>device has two<br>additional<br>outputs (4<br>channels), hence<br>the number of<br>electrodes has<br>been increased<br>from 8 to 16.<br>- The modified<br>device has<br>stainless steel<br>electrodes, which<br>do not have any<br>expiry and are<br>more reliable,<br>cost-effective,<br>and<br>environmentally<br>friendly than<br>single-use<br>electrodes.<br>-Hydrogel pads<br>are being added<br>to facilitate<br>attachment of<br>electrodes to<br>patient's skin and<br>to enhance<br>energy coupling.<br>- Silicone belts<br>are being added<br>to secure | | |
| Device Features | Modified device | Predicate Device | Comparison | | |
| Display | 12" LCD | 12" LCD | electrodes in place.<br>Identical | | |
| Number of Output<br>Modes | 03<br>(Prep, Tone, Sculpt) | 03<br>(Classic Vector, Power<br>Sequence, Dynamic<br>Rotation) | <b>Modified;</b><br>Renamed treatment modes<br>for usability. | | |
| Number of Output<br>Channels | 4<br><br>Synchronous<br>(a) Outputs 1 to 4 are<br>completely isolated. Only<br>power supply and ground<br>are common. | 2<br><br>Synchronous<br>(a) Outputs 1 to 2 are<br>completely isolated. Only<br>power supply and ground<br>are common. | <b>Modified</b><br>The number of outputs is being<br>increased from two to four to<br>provide enhanced<br>customization and flexibility to<br>the clinician.<br>The modified device has been<br>tested against EMI/EMC &<br>safety standards as per the IEC<br>60601-1 requirements.<br>All the test reports are<br>available under section<br>017_Electromagnetic<br>Compatability & Electrical Safety | | |
| 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 | NO | NO | Identical | | |
| Device Features | Modified device | Predicate Device | Comparison | | |
| Trip | | | | | |
| 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 | N/A | Identical | | |
| Voltage/Current<br>Level? | YES | YES | Identical | | |
| Timer Range<br>(minutes) | 45 Minutes – For Classic<br>Mode<br><br>15 Minutes – For Flex+<br>mode | 1 – 60 Minutes<br><br>In step of 1 minute | Modified<br>The modified<br>device has<br>prefixed<br>treatment time<br>of:<br><br>15 minutes and<br>45 minutes | | |
| Compliance with<br>Voluntary<br>Standards? | YES<br>IEC 60601-1,<br>IEC 60601-1-2,<br>IEC60601-2-10, &<br>ISO14971 | YES<br>IEC 60601-1,<br>IEC 60601-1-2,<br>IEC60601-2-10, & ISO14971 | Identical | | |
| Compliance With 21<br>CFR 898 | YES, the electrode cable<br>can never be plugged in<br>the AC socket, not even<br>accidentally | YES, the electrode cable<br>can never be plugged in the<br>AC socket, not even<br>accidentally | Identical | | |
| Weight | 32.66 Kgs | 32.66 Kgs | Identical | | |
| Dimension<br>(L X B X H) | 14"(L) X 17.5" (W) X<br>40"(H) | 14"(L) X 17.5" (W) X 40"(H) | Identical | | |
| Housing Material<br>and construction | ABS Plastic Body | ABS Plastic Body | Identical | | |
| Operating<br>Temperature | Temperature: +15°C to<br>+35°C | Temperature: +15°C to<br>+35°C | Identical | | |
| | Relative Humidity: 30 %<br>to 75 % (non-condensing) | Relative Humidity: 30 % to<br>75 % (non-condensing) | | | |
| | Barometric pressure:<br>700 hPa to 1060 hPa | Barometric pressure:<br>700 hPa to 1060 hPa | | | |
| Transport and<br>storage | Temperature: +5°C to<br>+45°C | Temperature: +5°C to<br>+45°C | Identical | | |
| Device Features | Modified device | Predicate Device | Comparison | | |
| | Relative Humidity: 10% to 85% (non-condensing) | Relative Humidity: 10% to 85% (non-condensing) | | | |
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## Comparison of output specification
## Mode: Prep
| S.No. | Parameters | MODIFIED DEVICE<br>truSculpt flex | PREDICATE DEVICE<br>Torc Body (K192039) |
|-------|-----------------------------------------------------------------------------|----------------------------------------------------------------------------------|----------------------------------------------------------------------------------|
| | Mode Name | Prep | Classic Vector |
| 1. | Waveform | Symmetrical Biphasic | Symmetrical Biphasic |
| 2. | Shape | Step Sine Wave | Step Sine Wave |
| 3. | Maximum Output | 100 Vpp @ 500Ω (± 10%) | 51.6 Vpp @ 500Ω (± 10%) |
| | Voltage | 125 Vpp @ 2KΩ (± 10%) | 62.4 Vpp @ 2KΩ (± 10%) |
| | | 133 Vpp @ 10KΩ (± 10%) | 66 Vpp @ 10KΩ (± 10%) |
| 4. | Maximum Output | 200 mA @ 500 Ohm | 103.2mA @ 500 Ohm |
| | Current | 62.5 mA @ 2K Ohm | 31.2 mA @ 2K Ohm |
| | | 13 mA @ 10K Ohm | 6.6 mA @ 10K Ohm |
| 5. | Pulse Width | 125 μS (± 10%) @500Ω | 124.7 μς (± 10%) @500Ω |
| 6. | Frequency | Channel1:<br>4000 Hz (± 10%) @500Ω<br>Channel 2:<br>4001 – 4100 Hz (± 10%) @500Ω | Channel1:<br>4000 Hz (± 10%) @500Ω<br>Channel 2:<br>4001 – 4100 Hz (± 10%) @500Ω |
| 7. | For Interferential<br>modes only:<br>- Beat<br>frequency | Resultant: 1 – 100 Hz | Resultant: 1 – 100 Hz |
| 8. | For multiphasic<br>Waveform<br>- Symmetrical<br>Phases?<br>- Phase duration | Yes<br>125 μS | Yes<br>124.7 μς |
| 9. | Net charge | 0 μC @500Ω (Being Biphasic in<br>nature the net charge would be<br>Zero) | 0 μC @500Ω (Being Biphasic in<br>nature the net charge would be<br>Zero) |
| 10. | Maximum Phase<br>Charge | 12.5 μC | 6.45 μC |
| 11. | Maximum Current<br>Density | 2.88 mA/cm²<br>*measured with 59 x 59<br>9mm square electrodes | 1.15 mA/cm²<br>*measured with 50 x 90mm rectangular<br>electrodes |
| 12. | Maximum Power<br>Density | 0.144 Watt/cm²<br>*measured with 59 x 59mm square<br>electrodes | 0.0295 Watt/cm²<br>*measured with 50 x 90mm rectangular<br>electrodes |
| 13. | Burst Mode<br>- Pulses Per<br>- Burst | N/A | N/A |
| S.No. | Parameters | MODIFIED DEVICE | PREDICATE DEVICE |
| | | truSculpt flex | Torc Body (K192039) |
| | - Burst Per<br>- second<br>- Burst Duration<br>- Duty Cycle | | |
| 14. | ON Time | N/A | N/A |
| 15. | OFF Time | N/A | N/A |
| 16. | Additional Features | Sweep Frequency 1- 100 Hz | Sweep Frequency 1- 100 Hz |
| S.No. | Parameters | MODIFIED DEVICE<br>truSculpt flex | PREDICATE DEVICE<br>Torc Body (K192039) |
| | Output Waveform | Tone | Power Sequence |
| 1. | Waveform | Symmetrical Biphasic | Symmetrical Biphasic |
| 2. | Shape | Square wave | Square Wave |
| 3. | Maximum Output | 70 Vpp @ 500Ω (± 10%) | 51 Vpp @ 500Ω (± 10%) |
| | Voltage | 125 Vpp @ 2KS2 (± 10%) | 63 Vpp @ 2KΩ (± 10%) |
| | | 150 Vpp @ 10KΩ (± 10%) | 66 Vpp @ 10KΩ (± 10%) |
| 4. | Maximum Output | 140 mA@ 500 Ohm | 102 mA @ 500 Ohm |
| | Current | 62.5 mA @ 2K Ohm | 31.5 mA @ 2K Ohm |
| | | 15 mA @ 10K Ohm | 6.6 mA @ 10K Ohm |
| ഗ് | Pulse Width | 350 µS (± 10%) @ 500Ω | 350 uS (+ 10%) |
| 6. | Frequency | 99 Hz (± 10%) @ 500Ω | 99 Hz (± 10%) |
| 7. | Beat frequency | N/A | N/A |
| 8. | For multiphasic | | |
| | Waveform | | |
| | Symmetrical<br>Phases? | Yes, Symmetrical Biphasic | Yes, Symmetrical Biphasic |
| | Phase duration | 350 µS (± 10%) | 350 uS (+ 10%) |
| 9. | Net charge | 0 µC @500Ω (Being Biphasic in | 0 µC @500Ω (Being Biphasic in |
| | | nature the net charge would be | nature the net charge would |
| | | Zero) | be Zero) |
| 10. | Maximum Phase | 24.50 µC @ 500 Ω Load | 17.85 µC @ 500 Ω Load |
| | Charge | | |
| 11. | Maximum Current | 2.02 mA/cm2 | 1.14 mA/cm² |
| | density | *measured with 59 x 59 mm square electrodes | *measured with 50 x 90mm rectangular<br>electrodes |
| 12. | Maximum Power | 0.070 Watts/cm2 | 0.029584 Watt/cm² |
| | Density | *measured with 59 x 59 mm square electrodes | *measured with 50 x 90mm rectangular<br>electrodes |
| 13. | Burst Mode | N/A | N/A |
| | Pulses Per Burst |…
