(93 days)
truFlex 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 arms, buttocks, thighs, and calves
- Relaxation of muscle spasms
- Prevention or retardation of disuse atrophy
- Increasing local blood circulation
- Muscle re-education
- Maintaining or increasing range of motion
- Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
- Stimulation of neuromuscular tissue for bulk muscle excitation in the legs or arms for rehabilitative purposes
- To be used under medical supervision for adjunctive therapy for the treatment of medical diseases and conditions
truFlex 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.
truFlex 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 addition of indication for use. The modified device generates the same stimulation to contract the muscles rhythmically to achieve the intended use.
The clinician can increase or decrease the intensity as per the desired stimulation. While modified device, complete care and considerable measures have been taken to retain its safety and effectiveness. The truFlex device complies with voluntary standards.
The modified device, as described in this submission, have only addition of the indication for use and name the device
The device has two treatment types:
- Classic - In Classic mode, the treatment duration is 45 minutes.
- 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 lead to toning and firming. SCULPT mode is available for Classic and flex+ treatments
Based on the provided FDA 510(k) Clearance Letter for the truFlex Muscle Stimulator, it's important to clarify that this document primarily focuses on demonstrating substantial equivalence to predicate devices rather than proving specific clinical efficacy or performance through a traditional clinical study with defined acceptance criteria for de novo AI/ML devices.
The truFlex device is a Powered Muscle Stimulator, classified as Class II, and uses electrical muscle stimulation (EMS). Its clearance is based on the premise that its safety and effectiveness are "demonstrated by performance data and a comparison of technical characteristics between the modified device and the predicate device," as stated on Page 4 and Page 9. This means the acceptance criteria are largely met by showing the device performs similarly to or within the established safety and performance parameters of already cleared, similar devices (predicates).
Therefore, the requested information points (1-9) about acceptance criteria, test sets, expert ground truth, MRMC studies, etc., typically apply to the rigorous clinical validation studies for novel medical devices, especially AI-driven ones where performance metrics like sensitivity, specificity, or AUC are critical. For a 510(k) based on substantial equivalence to predicate muscle stimulators, the "study" is often a combination of non-clinical bench testing, electrical safety testing, electromagnetic compatibility (EMC) testing, and comparison of technical specifications to demonstrate that the new device is as safe and effective as the predicate.
Given this context, I will address your points as best as possible based on the provided document, acknowledging where the information is not directly applicable or explicitly stated as it would be for a typical AI/ML clinical validation study.
Acceptance Criteria and Study for truFlex Muscle Stimulator
The acceptance criteria for the truFlex Muscle Stimulator, as described in this 510(k) submission, are primarily centered around demonstrating substantial equivalence to existing legally marketed predicate devices. This is achieved by showing that the truFlex device has the same intended use, similar technological characteristics, and meets recognized safety and performance standards as its predicates, without raising new questions of safety or effectiveness.
1. A table of acceptance criteria and the reported device performance
Since this is a substantial equivalence submission for a traditional medical device (not an AI/ML diagnostic/therapeutic device), the "acceptance criteria" are generally that the device performs within the established safety and effectiveness profiles of the predicates. The "reported device performance" is demonstrated through compliance with voluntary standards and direct comparison of specifications.
| Acceptance Criterion (Implicit for Substantial Equivalence) | Reported Device Performance (Summary from Submission) | Reference Pages |
|---|---|---|
| Safety: Compliance with recognized electrical safety standards (e.g., patient leakage, isolation). | Measured Patient Leakage: - Normal Condition: Less than 100µA (Predicate 1,2: <100µA) - Single Fault Condition: Less than 300µA (Predicate 1: <300µA, Predicate 2: <100µA) Method of Line Current Isolation: AC Power supply converted to DC Power supply through a medical-grade PSU, with 2XMOPP isolation (IEC60601-1). Confirmed identical to Predicate 1,2. | Page 13 |
| Safety: Compliance with recognized electromagnetic compatibility (EMC) standards. | Compliance with IEC 60601-1-2 (EMC): Stated as complying with this standard. | Pages 16-17, 21 |
| Safety: Compliance with general requirements for basic safety and essential performance. | Compliance with IEC 60601-1: Stated as complying with this standard. | Pages 16-17, 21 |
| Performance: Functional equivalence to predicate devices (waveform, output, modes, controls). | Waveform: Symmetrical Biphasic (identical to Predicate 1, similar to Predicate 2, different from Predicate 3). Shape: Step Sine Wave (identical to Predicate 1, different from Predicate 2, 3). Maximum Output Voltage/Current: Values provided and compared, showing similarity or within acceptable limits per FDA guidance. Pulse Width, Frequency, Beat Frequency: Values provided and compared, showing similarity. Number of Output Modes: 3 (Prep, Tone, Sculpt), identical to Predicate 1. | Pages 19-20 |
| Performance: Ability to deliver intended therapeutic effects consistent with predicates. | Principle of Operations: EMS Mode: electrical pulses mimic natural nerve signals, causing muscle contractions for strengthening, toning, and circulation. Rehabilitation Mode: low-frequency EMS for muscle re-education, disuse atrophy prevention, spasm relief. This is identical to Predicate 1 and 2, but differs from Predicate 3 (HIFEM + RF). | Pages 18-19 |
| Biocompatibility: Materials in contact with patient are biocompatible. | Compliance with ISO 10993-1, -5, -10: Stated as complying with these standards (Cytotoxicity, Skin sensitization, general evaluation). | Pages 17, 21 |
| Software Safety: Compliance with software life cycle processes. | Compliance with IEC 62304: Stated as complying with this standard. | Pages 16-17, 21 |
| Risk Management: Application of a risk management system. | Compliance with ISO 14971: Stated as complying with this standard. | Pages 16, 21 |
| Usability: Compliance with usability standards. | Compliance with IEC 60601-1-6: Stated as complying with this standard. | Pages 16-17, 21 |
| Expanded Indications: New indications consistent with predicate devices. | The submission emphasizes that the only modification is an expanded indication for use, which is already covered by the FDA-cleared predicate devices. | Page 21 |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not applicable in the context of a 510(k) clearance for this type of device, which relies on a comparison to predicate devices and adherence to performance standards rather than a clinical study with patient samples. The "test set" would be the device itself undergoing various engineering and safety tests.
- Data Provenance: The document details non-clinical testing for compliance with international standards (e.g., IEC, ISO). This is primarily bench testing, not patient-derived data. The manufacturer is Syrma Johari Medtech Limited, located in Jodhpur, Rajasthan, India. This suggests the testing and engineering data would originate from their facilities or contracted labs.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Number of Experts/Qualifications: Not applicable. For demonstrating substantial equivalence for a powered muscle stimulator, the "ground truth" is defined by the technical specifications, safety standards, and established performance of the predicate devices. It does not involve expert consensus on clinical findings in a test set, as would be the case for an AI-driven image analysis or diagnostic device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: Not applicable. There is no clinical test set requiring adjudication of medical findings.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- MRMC Study: Not applicable. The truFlex is a physical medical device (muscle stimulator), not an AI-assisted diagnostic or image analysis tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable. This device is an electrical muscle stimulator; it does not operate as a standalone algorithm in the way an AI diagnostic tool would. Its "performance" is its ability to generate specified electrical impulses safely and effectively.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Type of Ground Truth: The "ground truth" in this 510(k) submission is primarily established by:
- International Consensus Standards: Compliance with recognized IEC and ISO standards (e.g., IEC 60601-1 series for safety, IEC 62304 for software, ISO 10993 series for biocompatibility).
- Technical Specifications of Predicate Devices: The specific electrical output parameters (voltage, current, waveform, frequency, pulse width), operational modes, and physical characteristics of the legally marketed predicate devices. The new device must demonstrate it meets or is equivalent to these parameters.
8. The sample size for the training set
- Sample Size for Training Set: Not applicable. The truFlex is a hardware device cleared through substantial equivalence to predicate hardware devices. It does not involve AI/ML models that require a "training set" in the computational sense. The "training" for such devices involves product development, engineering, and manufacturing processes aimed at meeting specifications.
9. How the ground truth for the training set was established
- Ground Truth for Training Set: Not applicable, as there is no "training set" in the AI/ML sense. The "ground truth" for the development and testing of this device (if one were to use that term broadly) derived from engineering requirements, known electrical stimulation principles, and regulatory standards.
FDA 510(k) Clearance Letter - truFlex Muscle Stimulator
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.08.00
August 28, 2025
Syrma Johari Medtech Limited
Sabyasachi Nath
Senior General Manager-QARA
G-582-584, EPIP, Boranada
Jodhpur, Rajasthan 342012
India
Re: K251594
Trade/Device Name: truFlex
Regulation Number: 21 CFR 890.5850
Regulation Name: Powered Muscle Stimulator
Regulatory Class: Class II
Product Code: NGX
Dated: July 31, 2025
Received: July 31, 2025
Dear Sabyasachi Nath:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
Page 2
K251594 - Sabyasachi Nath Page 2
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory-assistance/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).
Page 3
K251594 - Sabyasachi Nath Page 3
Sincerely,
Tushar Bansal -S
Tushar Bansal, PhD
Acting 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
Page 4
Indications for Use
Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions. K251594
Please provide the device trade name(s). truFlex
Please provide your Indications for Use below.
truFlex 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 arms, buttocks, thighs, and calves
- Relaxation of muscle spasms
- Prevention or retardation of disuse atrophy
- Increasing local blood circulation
- Muscle re-education
- Maintaining or increasing range of motion
- Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
- Stimulation of neuromuscular tissue for bulk muscle excitation in the legs or arms for rehabilitative purposes
- To be used under medical supervision for adjunctive therapy for the treatment of medical diseases and conditions
The device safety and efficacy was demonstrated by performance data and a comparison of technical characteristics between the modified device and the predicate device.
Please select the types of uses (select one or both, as applicable).
☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)
truFlex Page 9 of 30
Page 5
Syrma Johari MedTech Limited. (Formerly known as Johari Digital Healthcare Limited)
Registered Office
G-582-584, EPIP,
Boranada, Jodhpur - 342012
Rajasthan, BHARAT
Contact: 0291-2942943
Design Center
402, Tower 2, WTC,
Kharadi, Pune - 411014
Maharashtra, BHARAT
CIN: U45201RJ1995PLC009997
510(k) Summary
K251594
Submitter Information:
| Field | Details |
|---|---|
| Name | Syrma Johari Medtech Limited |
| Address | G-582- 584 EPIP, Boranada, Jodhpur – India – 342012 |
| Name of Contact Person | Sabyasachi Nath Sr. GM-QARA, Syrma Johari Medtech Limited G-582- 584 EPIP, Boranada, Jodhpur – India – 342012 |
| Phone Number | +91- 9251617039 |
| Summary Preparation Date | Dec 03, 2024 |
Name of Subject Device:
| Field | Details |
|---|---|
| Device Name | truFlex Muscle Stimulator |
| Device Trade or Proprietary Name | truFlex |
| Common or Usual Name | Powered Muscle Stimulator |
| Classification Name | Stimulator, Muscle, Powered, For Muscle Conditioning |
| Classification Regulation | 21 CFR 890.5850, Class II |
| Classification Product Code | NGX, IPF |
Legally marketed Predicate Device 1
| Field | Details |
|---|---|
| Device Trade Name | truSculpt Flex |
| Classification Name | Stimulator, Muscle, Powered, For Muscle Conditioning |
| 510(K) No | K212866 |
| Classification Product Code | NGX |
| Address and Registration | Syrma Johari Medtech Limited (formerly known as Johari Digital healthcare limited) G-582, 584 EPIP, Boranada, Jodhpur – India – 342012 |
Legally marketed Predicate Device 2
| Field | Details |
|---|---|
| Device Trade Name | accufit |
| Classification Name | Stimulator, Muscle, Powered, For Muscle Conditioning |
| 510(K) No | K233926 |
| Classification Product Code | NGX, IPF |
| Address and Registration | Mettler Electronics Corporation 1333 South Claudina Street Anaheim, CA 92805 |
Legally marketed Predicate Device 3
BHARAT | SERBIA | USA www.syrmajoharimedtech.com
Page 6
Syrma Johari MedTech Limited. (Formerly known as Johari Digital Healthcare Limited)
Registered Office
G-582-584, EPIP,
Boranada, Jodhpur - 342012
Rajasthan, BHARAT
Contact: 0291-2942943
Design Center
402, Tower 2, WTC,
Kharadi, Pune - 411014
Maharashtra, BHARAT
CIN: U45201RJ1995PLC009997
| Field | Details |
|---|---|
| Device Trade Name | Btl-899ms |
| Classification Name | Powered Muscle Stimulator |
| 510(K) No | K240234 |
| Classification Product Code | NGX, IPF |
| Address and Registration | BTL Industries, Inc, North America 362 Elm Street Marlborough, Massachusetts 01752 |
Device Description
truFlex 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.
truFlex 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 addition of indication for use. The modified device generates the same stimulation to contract the muscles rhythmically to achieve the intended use.
The clinician can increase or decrease the intensity as per the desired stimulation. While modified device, complete care and considerable measures have been taken to retain its safety and effectiveness. The truFlex device complies with voluntary standards.
The modified device, as described in this submission, have only addition of the indication for use and name the device
The device has two treatment types:
- Classic - In Classic mode, the treatment duration is 45 minutes.
- 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.
BHARAT | SERBIA | USA www.syrmajoharimedtech.com
Page 7
Syrma Johari MedTech Limited. (Formerly known as Johari Digital Healthcare Limited)
Registered Office
G-582-584, EPIP,
Boranada, Jodhpur - 342012
Rajasthan, BHARAT
Contact: 0291-2942943
Design Center
402, Tower 2, WTC,
Kharadi, Pune - 411014
Maharashtra, BHARAT
CIN: U45201RJ1995PLC009997
Fig:- Prep Mode
- 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.
Fig:- Tone Mode
- SCULPT mode uses fast, sequential contractions of the muscles which lead to toning and firming. SCULPT mode is available for Classic and flex+ treatments
Fig:- Sculpt Mode
BHARAT | SERBIA | USA www.syrmajoharimedtech.com
Page 8
Syrma Johari MedTech Limited. (Formerly known as Johari Digital Healthcare Limited)
Registered Office
G-582-584, EPIP,
Boranada, Jodhpur - 342012
Rajasthan, BHARAT
Contact: 0291-2942943
Design Center
402, Tower 2, WTC,
Kharadi, Pune - 411014
Maharashtra, BHARAT
CIN: U45201RJ1995PLC009997
truFlex 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, and Relaxation of muscle spasms, Prevention or retardation of disuse atrophy, Increasing local blood circulation, Muscle re-education, Maintaining or increasing range of motion, Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis, Stimulation of neuromuscular tissue for bulk muscle excitation in the legs or arms for rehabilitative purposes and symptomatic relief and management of chronic long-term intractable pain
Where
- Reusable silicone belts (cummerbunds)
- Electrodes (Handpiece)
- Adhesive hydrogel pads
The device generates electrical stimulation to contract the muscles rhythmically to achieve its intended use.
While modified the device, complete care and considerable measures have been taken to retain its safety and effectiveness. The truFlex device complies with voluntary standards.
BHARAT | SERBIA | USA www.syrmajoharimedtech.com
Page 9
Syrma Johari MedTech Limited. (Formerly known as Johari Digital Healthcare Limited)
Registered Office
G-582-584, EPIP,
Boranada, Jodhpur - 342012
Rajasthan, BHARAT
Contact: 0291-2942943
Design Center
402, Tower 2, WTC,
Kharadi, Pune - 411014
Maharashtra, BHARAT
CIN: U45201RJ1995PLC009997
Indication for Use
truFlex 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 arms, buttocks, thighs, and calves
- Relaxation of muscle spasms
- Prevention or retardation of disuse atrophy
- Increasing local blood circulation
- Muscle re-education
- Maintaining or increasing range of motion
- Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
- Stimulation of neuromuscular tissue for bulk muscle excitation in the legs or arms for rehabilitative purposes
- To be used under medical supervision for adjunctive therapy for the treatment of medical diseases and conditions
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 (1. truSculpt Flex K212866. 2. Accufit, K233926, 3. emSculpt NEO BTL 899MS K240234)).
Summary of the technological characteristics of the device compared to the predicate
A comparison given below identifies all the changes between the modified and the predicate device:
BHARAT | SERBIA | USA www.syrmajoharimedtech.com
Page 10
Syrma Johari MedTech Limited. (Formerly known as Johari Digital Healthcare Limited)
Registered Office
G-582-584, EPIP,
Boranada, Jodhpur - 342012
Rajasthan, BHARAT
Contact: 0291-2942943
Design Center
402, Tower 2, WTC,
Kharadi, Pune - 411014
Maharashtra, BHARAT
CIN: U45201RJ1995PLC009997
Basic Device Characteristics – Comparison with Predicate Device
| Characteristics | Subject Device | Predicate Device 1 | Predicate Device 2 | Predicate Device 3 | Comparison |
|---|---|---|---|---|---|
| Device Name | truFlex | truSculpt Flex | Accufit | emSculpt NEO BTL-899MS | NA |
| 510(k) | Not Assigned | K212866 | K233926 | K240234 | NA |
| Manufacturer | Syrma Johari Medtech Limited (Formerly Known as Johari Digital Healthcare Limited) | Syrma Johari Medtech Limited (Formerly Known as Johari Digital Healthcare Limited) | Mettler / Lutronic Corporation | BTL Industries, Inc. | NA |
| Regulation Number | 21 CFR 890.5850 | 21 CFR 890.5850 | 21 CFR 890.5850 | 21 CFR 890.5850 | Subject device is identical to all Predicate Devices |
| Regulation Name | Powered Muscle Stimulator | Powered Muscle Stimulator | Powered Muscle Stimulator | Powered Muscle Stimulator | Subject device is identical to all Predicate Devices |
| Regulatory Class | Class II | Class II | Class II | Class II | Subject device is identical to all Predicate Devices |
| Product Code | NGX, IPF | NGX | NGX, IPF | NGX, IPF | Subject device is identical to all Predicate Devices |
| Panel | Physical Medicine | Physical Medicine | Physical Medicine | Physical Medicine | Subject device is identical to all Predicate Devices |
BHARAT | SERBIA | USA www.syrmajoharimedtech.com
Page 11
Syrma Johari MedTech Limited. (Formerly known as Johari Digital Healthcare Limited)
Registered Office
G-582-584, EPIP,
Boranada, Jodhpur - 342012
Rajasthan, BHARAT
Contact: 0291-2942943
Design Center
402, Tower 2, WTC,
Kharadi, Pune - 411014
Maharashtra, BHARAT
CIN: U45201RJ1995PLC009997
| Characteristics | Subject Device | Predicate Device 1 | Predicate Device 2 | Predicate Device 3 | Comparison |
|---|---|---|---|---|---|
| Indications for Use | • Improvement of abdominal tone, for strengthening of the abdominal muscles, for development of firmer abdomen.• Strengthening, toning and firming of arms, buttocks, thighs, and calves• Relaxation of muscle spasms• Prevention or retardation of disuse atrophy• Increasing local blood circulation• Muscle re-education• Maintaining or increasing range of motion• Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis• Stimulation of neuromuscular tissue for bulk muscle excitation in the legs or arms for rehabilitative purposes• To be used under medical supervision for | • Improvement of abdominal tone, for strengthening of the abdominal muscles, for development of firmer abdomen.• Strengthening, toning and firming of buttocks & thighs.• Relaxation of muscle spasms• Prevention or retardation of disuse atrophy• Increase local blood circulation• Muscle re-education• Maintaining or increasing range of motion• Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis | • Improvement of abdominal tone, for strengthening of the abdominal muscles, for development of firmer abdomen.• Improvement of muscle tone and firmness, for strengthening muscles in arms, thighs and buttocks areas. | The BTL-899MS device is indicated to be used for:• Improvement of abdominal tone, strengthening of the abdominal muscles, development of firmer abdomen.• Strengthening, toning and firming of buttocks, thighs and calves.• Improvement of muscle tone and firmness, for strengthening muscles in arms.The BTL-899MS device is intended to be used under medical supervision for adjunctive therapy for the treatment of medical diseases and conditions.The BTL-899MS device is indicated for use in stimulating neuromuscular tissue for bulk muscle excitation in the legs or arms for rehabilitative purposes. | Subject Device Indication for Use has been derived from Predicate Devices 1, 2, 3 |
BHARAT | SERBIA | USA www.syrmajoharimedtech.com
Page 12
Syrma Johari MedTech Limited. (Formerly known as Johari Digital Healthcare Limited)
Registered Office
G-582-584, EPIP,
Boranada, Jodhpur - 342012
Rajasthan, BHARAT
Contact: 0291-2942943
Design Center
402, Tower 2, WTC,
Kharadi, Pune - 411014
Maharashtra, BHARAT
CIN: U45201RJ1995PLC009997
| Characteristics | Subject Device | Predicate Device 1 | Predicate Device 2 | Predicate Device 3 | Comparison |
|---|---|---|---|---|---|
| adjunctive therapy for the treatment of medical diseases and conditions | The BTL-899MS device is indicated to be used for:• Improvement of abdominal tone, strengthening of the abdominal muscles, development of firmer abdomen.• Strengthening, toning and firming of buttocks, thighs and calves.• Improvement of muscle tone and firmness, for strengthening muscles in arms.The BTL-899MS device is intended to be used under medical supervision for adjunctive therapy for the treatment of medical diseases and conditions.The BTL-899MS device is indicated for use in stimulating neuromuscular tissue for bulk muscle excitation in the legs or arms for rehabilitative purposes. | Subject Device Indication for Use has been derived from Predicate Devices 1, 2, 3 | |||
| Indications for Use for Muscle Stimulators:• Relaxation of muscle spasms• Prevention or retardation of disuse atrophy• Increasing local blood circulation• Muscle re-education• Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis• Maintaining or increasing range of motion | • Relaxation of muscle spasms• Prevention or retardation of disuse atrophy• Increase local blood circulation• Muscle re-education• Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis• Maintaining or increasing range of motion | ||||
| Power Source | 100-240AC, 50/60Hz, 75VA | 100-240AC, 50/60Hz, 75VA | 100‐240VAC, 50/60Hz, 1.0A | 100 – 240 V AC, 50–60 Hz | Subject device is identical to all Predicate Devices |
| Therapeutic Modality | Electrical muscle stimulator | Electrical muscle stimulator | Electrical muscle stimulator | Electromagnetic stimulation accompanied by bipolar radiofrequency | Subject device is identical to Predicate Devices 1 and 2 |
| Treatment Output Mode | Electrode | Electrode | Electrode | Electrode | Subject device is identical to all Predicate Devices |
| Method of Line Current Isolation | The AC Power supply is converted to DC Power supply through a medical-grade PSU, which has isolation of 2XMOPP (IEC60601-1) | The AC Power supply is converted to DC Power supply through a medical-grade PSU, which has isolation of 2XMOPP (IEC60601-1) | Double Insulated Wire Non‐ Conductive Enclosure | Data not available | Subject device is identical to Predicate Devices 1,2 but no Data is available for Predicate Device 3 |
BHARAT | SERBIA | USA www.syrmajoharimedtech.com
Page 13
Syrma Johari MedTech Limited. (Formerly known as Johari Digital Healthcare Limited)
Registered Office
G-582-584, EPIP,
Boranada, Jodhpur - 342012
Rajasthan, BHARAT
Contact: 0291-2942943
Design Center
402, Tower 2, WTC,
Kharadi, Pune - 411014
Maharashtra, BHARAT
CIN: U45201RJ1995PLC009997
| Characteristics | Subject Device | Predicate Device 1 | Predicate Device 2 | Predicate Device 3 | Comparison |
|---|---|---|---|---|---|
| adjunctive therapy for the treatment of medical diseases and conditions | Indications for Use for Muscle Stimulators:• Relaxation of muscle spasms• Prevention or retardation of disuse atrophy• Increasing local blood circulation• Muscle re-education• Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis• Maintaining or increasing range of motion | ||||
| Power Source | 100-240AC, 50/60Hz, 75VA | 100-240AC, 50/60Hz, 75VA | 100‐240VAC, 50/60Hz, 1.0A | 100 – 240 V AC, 50–60 Hz | Subject device is identical to all Predicate Devices |
| Therapeutic Modality | Electrical muscle stimulator | Electrical muscle stimulator | Electrical muscle stimulator | Electromagnetic stimulation accompanied by bipolar radiofrequency | Subject device is identical to Predicate Devices 1 and 2 |
| Treatment Output Mode | Electrode | Electrode | Electrode | Electrode | Subject device is identical to all Predicate Devices |
| Method of Line Current Isolation | The AC Power supply is converted to DC Power supply through a medical-grade PSU, which has isolation of 2XMOPP (IEC60601-1) | The AC Power supply is converted to DC Power supply through a medical-grade PSU, which has isolation of 2XMOPP (IEC60601-1) | Double Insulated Wire Non‐ Conductive Enclosure | Data not available | Subject device is identical to Predicate Devices 1,2 but no Data is available for Predicate Device 3 |
| Isolation through transformer between device and patient | Isolation through transformer between device and patient |
Measured Patient Leakage
| Normal Condition (µA) | Less than 100µA | Less than 100µA | Less than 100µA | Data not available | Subject device is identical to Predicate Devices 1,2 but no Data is available for Predicate Device 3 |
| Single Fault Condition (µA) | Less than 300µA | Less than 300µA | Less than 100µA | Data not available | Subject device is identical to Predicate Devices 1,2 but no Data is available for Predicate Device 3 |
| Number of Output Modes | 03 | 03 | 04 | Data not available | Subject device is identical to Predicate Devices 1,2 but no Data is available for Predicate Device 3 |
| Number of Output Channels | 4 | 4 | 2 | 2 | Subject Device is identical to Predicate Device 1, and Similar to Predicate Devices 2 and 3 |
| Regulated Current or Voltage | Trans Conductance | Trans Conductance | Current = 100mA maximum | Data not available | Subject device is identical to Predicate Devices 1,2 but no Data is available for Predicate Device 3 |
BHARAT | SERBIA | USA www.syrmajoharimedtech.com
Page 14
Syrma Johari MedTech Limited. (Formerly known as Johari Digital Healthcare Limited)
Registered Office
G-582-584, EPIP,
Boranada, Jodhpur - 342012
Rajasthan, BHARAT
Contact: 0291-2942943
Design Center
402, Tower 2, WTC,
Kharadi, Pune - 411014
Maharashtra, BHARAT
CIN: U45201RJ1995PLC009997
| Characteristics | Subject Device | Predicate Device 1 | Predicate Device 2 | Predicate Device 3 | Comparison |
|---|---|---|---|---|---|
| Software / Firmware / Microprocessor Control | Yes | Yes | Yes | Yes | Subject device is identical to all Predicate Devices |
| Automatic Over Current Trip | Yes | Yes | Yes | Data not available | Subject device is identical to Predicate Devices 1,2 but no Data is available for Predicate Device 3 |
| Automatic No Load Trip | No | No | Yes | Data not available | Subject device is identical to Predicate Devices 1,2 but no Data is available for Predicate Device 3 |
| Automatic Shut Off | Yes | Yes | Yes | Yes | Subject device is identical to Predicate Devices 1,2 but no Data is available for Predicate Device 3 |
| User Override Control | Yes | Yes | Yes | Data not available | Subject device is identical to Predicate Devices 1,2 but no Data is available for Predicate Device 3 |
| Indicator Display | Yes | Yes | Yes | Yes | Subject device is identical to all Predicate Devices |
BHARAT | SERBIA | USA www.syrmajoharimedtech.com
Page 15
Syrma Johari MedTech Limited. (Formerly known as Johari Digital Healthcare Limited)
Registered Office
G-582-584, EPIP,
Boranada, Jodhpur - 342012
Rajasthan, BHARAT
Contact: 0291-2942943
Design Center
402, Tower 2, WTC,
Kharadi, Pune - 411014
Maharashtra, BHARAT
CIN: U45201RJ1995PLC009997
| Characteristics | Subject Device | Predicate Device 1 | Predicate Device 2 | Predicate Device 3 | Comparison |
|---|---|---|---|---|---|
| On / Off Status | Yes | Yes | Yes | Yes | Subject device is identical to all Predicate Devices |
| Voltage / Current Level | Yes | Yes | Yes | Data not available | Subject device is identical to Predicate Devices 1,2 but no Data is available for Predicate Device 3 |
| Timer range | 15, 30, 45 Mins | 15, 30, 45 Mins | 15, 30, 45 Mins | up to 30 mins | Subject device is identical to all Predicate Devices |
BHARAT | SERBIA | USA www.syrmajoharimedtech.com
Page 16
Syrma Johari MedTech Limited. (Formerly known as Johari Digital Healthcare Limited)
Registered Office
G-582-584, EPIP,
Boranada, Jodhpur - 342012
Rajasthan, BHARAT
Contact: 0291-2942943
Design Center
402, Tower 2, WTC,
Kharadi, Pune - 411014
Maharashtra, BHARAT
CIN: U45201RJ1995PLC009997
| Characteristics | Subject Device | Predicate Device 1 | Predicate Device 2 | Predicate Device 3 | Comparison |
|---|---|---|---|---|---|
| Compliance: Voluntary Standards | • IEC 60101-1, an International Standard on Medical electrical equipment general requirements for safety (FDA Recognition List Number 19-4);• IEC 60601-1-2, an International Standard on Medical electrical equipment, electromagnetic compatibility (FDA Recognition List Number 19-8);• IEC 60601-2-10 an International Standard on Medical electrical equipment - Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle | • IEC 60101-1, an International Standard on Medical electrical equipment general requirements for safety (FDA Recognition List Number 19-4);• IEC 60601-1-2, an International Standard on Medical electrical equipment, electro-magnetic compatibility (FDA Recognition List Number 19-8);• IEC 60601-2-10 an International Standard on Medical electrical equipment - Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators (FDA Recognition List Number 17-16), and• IEC 62304 Medical device software - Software life cycle processes (FDA | • IEC 60101-1, an International Standard on Medical electrical equipment general requirements for safety (FDA Recognition List Number 19-4);• IEC 60601-1-2, an International Standard on Medical electrical equipment, electro-magnetic compatibility (FDA Recognition List Number 19-8);• IEC 60601-1-6, an International Standard on Medical electrical equipment – Part 1-6: General requirements for basic safety and essential performance – Collateral standard: Usability (FDA Recognition List Number 5-132),• IEC 60601-2-10 an International Standard on Medical electrical equipment - Part 2-10: Particular requirements for the basic safety and essential performance of | IEC 60601-1 Medical electrical equipment – Part 1: General requirements for basic safety and essential performanceIEC 60601-1-2 Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility – Requirements and testsIEC 60601-1-6 Medical electrical equipment – Part 1-6: General requirements for basic safety and essential performance – Collateral standard: UsabilityIEC 62304 Medical device software – Software life cycle processesISO 14971 | Subject device is identical to all Predicate Devices |
BHARAT | SERBIA | USA www.syrmajoharimedtech.com
Page 17
Syrma Johari MedTech Limited. (Formerly known as Johari Digital Healthcare Limited)
Registered Office
G-582-584, EPIP,
Boranada, Jodhpur - 342012
Rajasthan, BHARAT
Contact: 0291-2942943
Design Center
402, Tower 2, WTC,
Kharadi, Pune - 411014
Maharashtra, BHARAT
CIN: U45201RJ1995PLC009997
| Characteristics | Subject Device | Predicate Device 1 | Predicate Device 2 | Predicate Device 3 | Comparison |
|---|---|---|---|---|---|
| stimulators (FDA Recognition List Number 17-16), and• IEC TR 60601-4-2 Medical electrical equipment - Part 4-2: Guidance and interpretation - Electromagnetic immunity: performance of medical electrical equipment and medical electrical systems (FDA Recognition List Number 19-19).• IEC 62304 Medical device software - Software life cycle processes (FDA Recognition List Number 13-79) | Recognition List Number 13-79) | nerve and muscle stimulators(FDA Recognition List Number 17-16), and• IEC TR 60601-4-2 Medical electrical equipment - Part 4-2: Guidance and interpretation - Electromagnetic immunity: performance of medical electrical equipment and medical electrical systems (FDA Recognition List Number 19-19).• IEC 62304 Medical device software - Software life cycle processes (FDA Recognition List Number 13-79)• Cytotoxicity per ISO 10993-5:2009• Skin sensitization per ISO 10993-10:2021 | Medical devices – Application of risk management to medical devicesISO 10993-1 Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management processISO 10993-5 Biological evaluation of medical devices – Part 5: Tests for in vitro cytotoxicityISO 10993-10 Biological evaluation of medical devices – Part 10: Tests for irritation and skin sensitization | Subject device is identical to all Predicate Devices | |
| Compliance: 21CFR898 | Yes | Yes | Yes | Data not available | Subject device is identical to Predicate Devices 1,2 but no Data is available for Predicate Device 3 |
BHARAT | SERBIA | USA www.syrmajoharimedtech.com
Page 18
Syrma Johari MedTech Limited. (Formerly known as Johari Digital Healthcare Limited)
Registered Office
G-582-584, EPIP,
Boranada, Jodhpur - 342012
Rajasthan, BHARAT
Contact: 0291-2942943
Design Center
402, Tower 2, WTC,
Kharadi, Pune - 411014
Maharashtra, BHARAT
CIN: U45201RJ1995PLC009997
| Characteristics | Subject Device | Predicate Device 1 | Predicate Device 2 | Predicate Device 3 | Comparison |
|---|---|---|---|---|---|
| Weight | 32.66 | 32.66 | 27Kg | 70Kg | Subject Device is identical to Predicate Devices 1 and 2, but similar to Predicate Devices 3 |
| Dimensions (mm) W x L x H | 445 x 356 x 1016 | 445 x 356 x 1016 | 452 x 582 x 1101 | 592 x 730 x 985 | Subject Device is identical to Predicate Devices 1 and 2, but similar to Predicate Devices 3 |
| Housing, Materials and Construction | ABS Plastic | ABS Plastic | ABS Plastic | Data not available | Subject device is identical to Predicate Devices 1,2 but no Data is available for Predicate Device 3 |
| Medical Equipment Classification | Type BF | Type BF | Type BF | Type BF | Subject device is identical to all Predicate Devices |
| Principle of Operations | EMS Mode: truFlex uses Electrical Muscle Stimulation (EMS) to deliver electrical pulses to the targeted muscle groups. These pulses mimic natural nerve signals, causing muscle contractions that lead to strengthening, toning, and | 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 principle of operation of the accufit device is to provide direct electrical stimulation of muscles which produces muscle contractions in and around the area of the treatment electrodes. | HIFEM® Mode: High-Intensity Focused Electromagnetic (HIFEM®) technology induces supramaximal contractions in targeted muscles. These contractions go beyond voluntary effort, promoting muscle hypertrophy and increased strength. | Subject Device is identical to Predicate Devices 1 and 2 but not matching with Predicate Device 3 |
BHARAT | SERBIA | USA www.syrmajoharimedtech.com
Page 19
Syrma Johari MedTech Limited. (Formerly known as Johari Digital Healthcare Limited)
Registered Office
G-582-584, EPIP,
Boranada, Jodhpur - 342012
Rajasthan, BHARAT
Contact: 0291-2942943
Design Center
402, Tower 2, WTC,
Kharadi, Pune - 411014
Maharashtra, BHARAT
CIN: U45201RJ1995PLC009997
| Characteristics | Subject Device | Predicate Device 1 | Predicate Device 2 | Predicate Device 3 | Comparison |
|---|---|---|---|---|---|
| increased local circulation.Rehabilitation Mode:truFlex operates in a low-frequency EMS mode designed for therapeutic purposes, such as muscle re-education, prevention of disuse atrophy, and relief of muscle spasms. | RF Mode: Radiofrequency (RF) energy is simultaneously applied to heat the fat layer, leading to lipolysis (fat cell destruction). RF energy also enhances blood flow and optimizes muscle stimulation during treatments. |
Comparison of output specification
| S.No. | Parameters | Subject device - truFlex | Predicate 1 - truSculpt Flex - K192039 | Predicate 2 - Accufit - K233926 | Predicate 3 - emSculpt NEO - K240234 |
|---|---|---|---|---|---|
| 1 | Type of mode | 3 (Prep, Tone, Sculpt) | 3 (Prep, Tone, Sculpt) | 2 | N/A |
| 2 | Waveform | Symmetrical Biphasic | Symmetrical Biphasic | 2 (Biphasic and Interferential (4P)) | Symmetrical Biphasic Pulsed Magnetic (HIFEM) |
| 3 | Shape | Step Sine Wave | Step Sine Wave | Square (Biphasic) Sinusoidal (Interferential (4P)) | Sine Wave |
| 4 | Maximum Output Voltage | 100 Vpp @ 500Ω125 Vpp @ 2KΩ133 Vpp @ 10KΩ | 100 Vpp @ 500Ω125 Vpp @ 2KΩ133 Vpp @ 10KΩ | 104 @ 500Ω;197 @ 2kΩ; 178@ 10kΩ | 100 Vpp @ 500Ω |
| 5 | Maximum Output Current | 200 mA @ 500Ω62.5 mA @ 2KΩ13 mA @ 10KΩ | 200 mA @ 500Ω62.5 mA @ 2KΩ13 mA @ 10KΩ | 106 @ 500Ω; 49@ 2kΩ; 9 @10kΩ | 251 mA @ 500Ω |
BHARAT | SERBIA | USA www.syrmajoharimedtech.com
Page 20
Syrma Johari MedTech Limited. (Formerly known as Johari Digital Healthcare Limited)
Registered Office
G-582-584, EPIP,
Boranada, Jodhpur - 342012
Rajasthan, BHARAT
Contact: 0291-2942943
Design Center
402, Tower 2, WTC,
Kharadi, Pune - 411014
Maharashtra, BHARAT
CIN: U45201RJ1995PLC009997
| S.No. | Parameters | Subject device - truFlex | Predicate 1 - truSculpt Flex - K192039 | Predicate 2 - Accufit - K233926 | Predicate 3 - emSculpt NEO - K240234 |
|---|---|---|---|---|---|
| 6 | Pulse Width | 125 μs (±10%) @ 500Ω | 125 μs (±10%) @ 500Ω | 40‐800 μSec | AP-C-1 – 280 µs ±20% or AP-C-2 – 190 µs ±20% |
| 7 | Frequency | Channel1: 4000 Hz (±10%)Channel2: 4001– 4100 Hz (±10%)Resultant: 1–100 Hz | Channel1: 4000 Hz (±10%)Channel2: 4001– 4100 Hz (±10%)Resultant: 1–100 Hz | 1‐200 Hz | 1‐150 Hz |
| 8 | Beat Frequency | 1–100 Hz | 1–100 Hz | 1‐200 Hz | 1‐150 Hz |
| 9 | Multiphasic Waveform | Yes125 μs | Yes125 μs | Yes | Yes |
| 10 | Net Charge | 0 μC @ 500Ω | 0 μC @ 500Ω | Net Charge = 0 μC (Biphasic & Interferential (4P) pulses are symmetrical about 0V) | 0 μC (current is symmetrical) |
| 11 | Maximum Phase Charge | 12.5 μC | 12.5 μC | 42.4 μC, 500 Ω | Unknown |
| 12 | Maximum Current Density | 2.88 mA/cm² | 2.88 mA/cm² | 5.13 mA/cm2 , 500 Ω | 3.6 mA/cm2 (10 cm diameter coil applicator) |
| 13 | Maximum Power Density | 0.144 W/cm² | 0.144 W/cm² | 0.043 W/cm²,500 Ω | Unknown |
| 14 | ON Time | 0-6 seconds | 0-6 seconds | Biphasic 1 – 240 seconds, Interferential (4P) NA | Programmable |
| 15 | OFF Time | 0-4 seconds | 0-4 seconds | Biphasic 1 – 240 seconds, Interferential (4P) NA | Programmable |
| 16 | Additional Features | Sweep Frequency 1– 100 Hz | Sweep Frequency 1–100 Hz | N/A | HIFEM, touchscreen, dual applicators |
There are no changes to the subject device in terms of its fundamental scientific principles, performance specifications, or operation when compared to the FDA-cleared predicate devices (TruSculpt Flex (K212866), Accufit (K233926) and emSculpt NEO BTL 899MS (K240234)).
BHARAT | SERBIA | USA www.syrmajoharimedtech.com
Page 21
Syrma Johari MedTech Limited. (Formerly known as Johari Digital Healthcare Limited)
Registered Office
G-582-584, EPIP,
Boranada, Jodhpur - 342012
Rajasthan, BHARAT
Contact: 0291-2942943
Design Center
402, Tower 2, WTC,
Kharadi, Pune - 411014
Maharashtra, BHARAT
CIN: U45201RJ1995PLC009997
In the subject device, truFlex, the only modification is an expanded indication for use, which is already covered by the FDA-cleared predicate devices (TruSculpt Flex (K212866), Accufit (K233926) and emSculpt NEO BTL 899MS (K240234)).
Furthermore, there are no technological differences, fundamental scientific principles, performance specifications, indication for use and operation between the FDA-cleared predicate and subject devices that raise concerns regarding safety or effectiveness.
The observed deviations in values in table of Substantial Equivalence remain within acceptable limits as per: "Guidance Document for Powered Muscle Stimulator 510(k)s" (issued June 9, 1999) and ANSI/AAMI NS4:2013 (R2017) standard for electrical stimulators. Thus, the modifications do not impact on the overall safety and effectiveness of the device.
Non-clinical Testing (Performance, Bench Testing)
| Standard Number | Standard Description | FDA recognition number |
|---|---|---|
| ISO 14971: 2019 | Medical devices -- Application of risk management to medical devices | 5-125 |
| IEC60601-1:2005+AMD:2012 | Medical electrical equipment - Part 1: General requirements for basic safety and essential performance | 19-49 |
| 60601-1-2:2014 | Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests | 19-36 |
| IEC 60601-2-10 | Medical electrical equipment - Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators | 17-16 |
| IEC 60601-1-6: 2020 | Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability | 5-132 |
| IEC 62304:2015 | Medical device software - Software life cycle processes | 13-79 |
| ISO 10993-1: 2018 | Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process | 2-258 |
| ISO 10993-5: 2009 | Biological evaluation of medical devices Part 5: Tests for in vitro cytotoxicity | 2-245 |
| ISO 10993-10: 2021 | Biological evaluation of medical devices Part 10: Tests for skin sensitization | 2-174 |
| IEC TR 60601-4-2 | Medical electrical equipment - Part 4-2: Guidance and interpretation - Electromagnetic immunity: performance of medical electrical equipment and medical electrical systems | 19-19 |
CONCLUSION
The subject device, truFlex, is substantially equivalent to the FDA-cleared predicate devices TruSculpt Flex (K212866), Accufit (K233926) and emSculpt NEO BTL 899MS (K240234) in terms of
BHARAT | SERBIA | USA www.syrmajoharimedtech.com
Page 22
Syrma Johari MedTech Limited. (Formerly known as Johari Digital Healthcare Limited)
Registered Office
G-582-584, EPIP,
Boranada, Jodhpur - 342012
Rajasthan, BHARAT
Contact: 0291-2942943
Design Center
402, Tower 2, WTC,
Kharadi, Pune - 411014
Maharashtra, BHARAT
CIN: U45201RJ1995PLC009997
fundamental scientific principles, technology, performance, operation, and indications for use. Based on this, the truFlex device meets the criteria for substantial equivalence under 510(k) clearance, demonstrating no new concerns regarding safety or effectiveness compared to the predicate devices
BHARAT | SERBIA | USA www.syrmajoharimedtech.com
§ 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).