Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a standard electrical muscle stimulator with no mention of AI or ML in its operation, device description, or performance studies.

Therapeutic

No.
The device's intended use is for muscle toning, strengthening, and firming which are considered cosmetic or fitness benefits rather than therapeutic treatment of a disease, injury, or medical condition.

Diagnostic

No

The device is an electrical muscle stimulator intended for strengthening, toning, and firming muscles, not for diagnosing medical conditions.

SaMD (Software as a Medical Device)

No

The device description explicitly details hardware components including a console with a touchscreen, handpiece pairs, electrodes, hydrogel pads, and silicone belts, which are integral to its function as an electrical muscle stimulator.

IVD (In Vitro Diagnostic)

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

Here's why:

IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
truSculpt flex Function: The truSculpt flex is an electrical muscle stimulator that delivers electrical impulses to the skin to directly stimulate muscles. It does not analyze any biological specimens.
Intended Use: The intended use is for improving muscle tone, strengthening, and firming, which are physical effects achieved through direct stimulation, not through the analysis of biological samples.

Therefore, the truSculpt flex falls under the category of a physical therapy or aesthetic device, not an In Vitro Diagnostic.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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.

Product codes

NGX

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.
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.
SCULPT mode uses fast, sequential contractions of the muscles which leads to toning and firming. SCULPT mode is available for Classic and flex+ treatments

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

Not Found

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 truSculpt flex device 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 results: The information and testing presented in this traditional 510(k) demonstrate that the truSculpt flex device performs as designed and intended, and is substantially equivalent to the predicate device (K192039). The changes made do not affect the safety and effectiveness of the device.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K192039

Reference Device(s)

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.

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

1

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

2

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)

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

Device Name	truSculpt flex muscle stimulator
Submitters name/
contact details	Nisha Johari
Johari Digital Healthcare Ltd
G-582- 584 EPIP, Boranada,
Jodhpur – India – 342012
Contact number: + 91-9829954228
Summary
Preparation Date	28-Oct-2022
Device Trade Name	truSculpt flex
Device / Proprietary
Name	truSculpt flex
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	K192039
Address and
Registration	Johari Digital Healthcare Ltd
G-582, 584 EPIP, Boranada,
Jodhpur – India – 342012
Contact Person:	Nisha Johari
FDA Registration	8040537

4

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

5

• 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

6

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)
1. Electrodes ( Handpiece )
1. 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).

7

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)
(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)
(b) Isolation thru transformer between device and patient	Identical
Device Features	Modified device	Predicate Device	Comparison
Patient Leakage
Current
Normal condition	Normal condition = less
than
100μΑ	Normal condition = less
than
100μΑ	Identical
Single Fault
condition	Single fault condition =
less than 300μΑ	Single fault condition = less
than 300μA
Components	Main unit,
8 Stainless steel reusable
electrodes pairs (16
electrodes)
4 electrode lead wires
1 AC Power Cord
4 Hydrogel pads
2 reusable silicone belts
(cummerbunds)	Main unit,
8 self adhesive electrodes ,
4 electrode lead wires,
1 AC Power Cord	Modified;
-The modified
device has two
additional
outputs (4
channels), hence
the number of
electrodes has
been increased
from 8 to 16.

The modified
device has
stainless steel
electrodes, which
do not have any
expiry and are
more reliable,
cost-effective,
and
environmentally
friendly than
single-use
electrodes.
-Hydrogel pads
are being added
to facilitate
attachment of
electrodes to
patient's skin and
to enhance
energy coupling.
Silicone belts
are being added
to secure | | |
| Device Features | Modified device | Predicate Device | Comparison | | |
| Display | 12" LCD | 12" LCD | electrodes in place.
Identical | | |
| Number of Output
Modes | 03
(Prep, Tone, Sculpt) | 03
(Classic Vector, Power
Sequence, Dynamic
Rotation) | Modified;
Renamed treatment modes
for usability. | | |
| Number of Output
Channels | 4

Synchronous
(a) Outputs 1 to 4 are
completely isolated. Only
power supply and ground
are common. | 2

15 Minutes – For Flex+
mode | 1 – 60 Minutes

In step of 1 minute | Modified
The modified
device has
prefixed
treatment time
of:

8

9

10

11

12

Comparison of output specification

Mode: Prep

| S.No. | Parameters | MODIFIED DEVICE
truSculpt flex | PREDICATE DEVICE
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:
4000 Hz (± 10%) @500Ω
Channel 2:
4001 – 4100 Hz (± 10%) @500Ω | Channel1:
4000 Hz (± 10%) @500Ω
Channel 2:
4001 – 4100 Hz (± 10%) @500Ω |
| 7. | For Interferential
modes only:

Beat
frequency | Resultant: 1 – 100 Hz | Resultant: 1 – 100 Hz |
| 8. | For multiphasic
Waveform
Symmetrical
Phases?
Phase duration | Yes
125 μS | Yes
124.7 μς |
| 9. | 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) |
| 10. | Maximum Phase
Charge | 12.5 μC | 6.45 μC |
| 11. | Maximum Current
Density | 2.88 mA/cm²
*measured with 59 x 59
9mm square electrodes | 1.15 mA/cm²
*measured with 50 x 90mm rectangular
electrodes |
| 12. | Maximum Power
Density | 0.144 Watt/cm²
*measured with 59 x 59mm square
electrodes | 0.0295 Watt/cm²
*measured with 50 x 90mm rectangular
electrodes |
| 13. | Burst Mode
Pulses Per
Burst | N/A | N/A |
| S.No. | Parameters | MODIFIED DEVICE | PREDICATE DEVICE |
| | | truSculpt flex | Torc Body (K192039) |
| | - Burst Per
second
Burst Duration
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
truSculpt flex | PREDICATE DEVICE
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
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
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
electrodes |
| 13. | Burst Mode | N/A | N/A |
| | Pulses Per Burst | | |
| | Burst Per | | |
| | second | | |
| | Burst Duration | | |
| | Duty Cycle | | |
| 14. | ON Time | 6 seconds | 6 seconds |
| 15. | OFF Time | 4 seconds | 4 seconds |
| 13 | Additional | | |
| | Features | | |
| S.No. | Parameters | MODIFIED DEVICE | PREDICATE DEVICE |
| | | truSculpt flex | Torc Body (K192039) |
| | Output | Sculpt | Dynamic Rotation |
| | Waveform | | |
| 1. | Waveform | Symmetrical Biphasic | Symmetrical Biphasic |
| 2. | Shape | Modulated Sine Wave | Modulated Sine Wave |
| 3. | Maximum Output | 100 Vpp @ 500Ω (± 10%) | 51.2 Vpp @ 500Ω (± 10%) |
| | Voltage | 125 Vpp @ 2KΩ (± 10%) | 63.2 Vpp @ 2KΩ (± 10%) |
| | | 135 Vpp @ 10KΩ (± 10%) | 66 Vpp @ 10KΩ (± 10%) |
| 4. | Maximum Output | 200 mA @ 500 Ohm | 102.4 mA @ 500 Ohm |
| | Current | 62.5 mA @ 2K Ohm | 31.6 mA @ 2K Ohm |
| | | 13.5 mA @ 10K Ohm | 6.56 mA @ 10K Ohm |
| 5. | Pulse Width | 125 μS (± 10%) @ 500Ω | 124.9 μS (± 10%) @ 500Ω |
| 6. | Frequency | 4000 Hz (± 10%) @ 500Ω
Resultant: 1 – 100 Hz | 4002 Hz (± 10%) @ 500Ω
Resultant: 1 - 100 Hz |
| 7. | Beat frequency | N/A | N/A |
| 8. | For multiphasic | | |
| | Waveform | | |
| | Symmetrical | Yes, Symmetrical Biphasic | Yes, Symmetrical Biphasic |
| | Phases? | | |
| | Phase duration | 125 μS (± 10%) | 124.9 μS (± 10%) |
| 9. | 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) |
| 10. | Maximum Phase
Charge | 12.5 μC | 6.4 μC |
| 11A. | Maximum | 2.88 mA/cm²
*measured with 59 x 59
9mm square electrodes | 1.14 mA/cm²
*measured with 50 x 90mm rectangular
electrodes |
| | | | |
| 12A. | Maximum Power
Density | 0.144 Watt/cm²
*measured with 59 x 59mm square electrodes | 0.0291 Watts/cm² |
| 13. | Burst Mode
Pulses Per | N/A | N/A |
| | Burst | | |
| | Burst Per | | |
| | second | | |
| | Burst Duration | | |
| | Duty Cycle | | |
| 14. | ON Time | N/A | N/A |
| 15. | OFF Time | N/A | N/A |
| 13 | Additional
Features | Sweep Frequency 1- 100 Hz | Sweep Frequency 1- 100 Hz |
| | | | |

13

Traditional 510(K) — K212866

truSculpt flex 510(K) Summary

14

Mode: Tone

15

Mode: Sculpt

16

There are no changes to the indications for use, fundamental scientific principles, performance specifications, or operation of the device. Although there are minor differences observed between the individual mode parameters of truSculpt flex and the predicate device, no differences found raised any questions regarding the safety and effectiveness of the modified device as the observed deviation in values is within the limits as per "Guidance Document for Powered Muscle Stimulator 510(k)s", issued on June 9, 1999, ANSI/AAMI NS4:2013 (R2017) standard for electrical stimulators.

The fundamental scientific technology is not changed in the modified device, and the changes are solely considered for ease of use for the clinician. The truSculpt flex 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.

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 truSculpt flex device 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)

CONCLUSION

The information and testing presented in this traditional 510(k) demonstrate that the truSculpt flex device performs as designed and intended, and is substantially equivalent to the predicate device (K192039). The changes made do not affect the safety and effectiveness of the device.