(286 days)
GYMFORM®ABS& CORE is intended to stimulate healthy muscles in order to improve or facilitate muscle performance. The ABS& CORE may be considered a technique or method for muscle training. 2-area belt is intended for use on the muscles in abdomen or lower back separately. Mini belt is intended for use on the muscles in arms, legs, thighs or buttocks areas separately.
GYMFORM® ABS&CORE is a two channels battery operated muscle stimulation system specifically designed to stimulation the muscles.
The 2-area belt is intended for use on the muscles in abdomen or lower back separately.
Mini belt is intended for use on the muscles in arms, legs, thighs and buttocks areas separately.
It is comprised of a console for signal generation, two belts (2-area belt and mini belt) for fixation, and electrode pads for signal connection to skin. The electrode pads are replaceable.
Power is derived from 2 "AAA" batteries located in a compartment protected by a removable battery cover. There is no current passed from side to side. The user cannot access the wiring or connectors within the belt.
The stimulator sends gentle electrical current to targeted muscle group through the electrodes placed on the skin. The parameters of the device are controlled by the buttons. Its intensity level can be adjustable by user.
The provided text describes the 510(k) submission for the GYMFORM® ABS&CORE, Model: VDPGYCSET0042, a powered muscle stimulator. The purpose of a 510(k) submission is to demonstrate that the new device is substantially equivalent to a legally marketed predicate device, meaning it is as safe and effective. It does not typically involve detailed studies proving novel device performance against specific clinical acceptance criteria in the way a new drug or advanced diagnostic AI might.
Instead, the "acceptance criteria" here are compliance with recognized safety and performance standards, and the "study" is a series of laboratory bench tests comparing the new device's specifications and performance against these standards and the predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the GYMFORM® ABS&CORE are largely based on compliance with international standards for medical electrical equipment and a comparison to predicate devices, demonstrating substantial equivalence in terms of safety and effectiveness.
| Acceptance Criterion (Standard/Comparison) | Reported Device Performance |
|---|---|
| Safety and Effectiveness (General) | Substantially Equivalent to predicate devices (K130074, K111476) |
| Electrical Safety (IEC 60601-1 and IEC 60601-2-10 standards) | Complies with IEC 60601-1 and IEC 60601-2-10 |
| Electromagnetic Compatibility (EMC) (IEC 60601-1-2 standard) | Complies with IEC 60601-1-2 |
| Software Verification and Validation (FDA Guidance for Pre-Market Submissions and for Software Contained in Medical Devices) | Verified and Validated |
| Waveform Output Specifications (IEC 60601-2-10 and Guidance for Powered Muscle Stimulator) | Verified specifications within acceptable ranges compared to predicates |
| - Maximum Output Voltage (Vpeak-to-peak) | 132V @ 500Ω; 138V @ 2kΩ; 140V @ 10kΩ (vs. 108-126V for predicates) |
| - Maximum Current Density (Ipeak-to-peak) | 264mA @ 500Ω; 69mA @ 2kΩ; 14mA @ 10kΩ (vs. 216-12.6mA for predicates) |
| - Frequency range | 2 Hz, 10 Hz, 50 Hz, 90 Hz, 120 Hz (vs. 1-120 Hz for predicates) |
| - Pulse width range | 108μs / 124μs (vs. 100-120 μs for predicates) |
| - Pulse duration | Varies by mode, e.g., 500ms (Mode 1), 11.1ms (Mode 2) (similar to Predicate I) |
| - Net Charge | 19.2µC @ 500Ω (vs. 15.7µC for Predicate I) |
| - Maximum Phase Charge | 16.4µC @ 500Ω (vs. 13.0µC for Predicate I) |
| - Maximum Current Density (mA/cm²) | 0.082 mA/cm² @ 500Ω (vs. 0.057-0.55 mA/cm² for predicates) |
| - Maximum Power Density | 94.8 μW/cm² @ 500Ω (vs. 53.8 μW/cm² for Predicate I) |
| - ON time / OFF time | 0.5s / 0.5s (vs. 1s / 1s for Predicate I) |
| - Duty Cycle | 0.02%~1.28% (vs. 0.02%~1.19% for Predicate I) |
| Dispersion and Shelf Life (ASTM F 1980-07, Guidance: Shelf Life of Medical Device) | Tested |
| Adhesion (Section 5.4 of AAMI EC 12_2000_(R) 2010 Disposable ECG electrodes) | Tested |
| Biocompatibility (ISO10993-5 and ISO10993-10 requirements) | All user contacting materials comply |
| Functional Specifications (Power sources, leakage current, channels, modes, intensity, timer, weights, dimensions) | Compared to predicate devices; minor differences noted but compliant with IEC standards and guidance |
2. Sample Size Used for the Test Set and Data Provenance
This document describes a 510(k) submission, which relies primarily on bench testing and a comparison to predicate devices, not human clinical trials or retrospective/prospective medical data sets in the typical sense of AI/diagnostic device studies.
- Test Set Sample Size: Not applicable in the context of human subjects or medical images. The "test set" here refers to the device itself being subjected to various laboratory tests.
- Data Provenance: The data comes from internal laboratory bench testing conducted by the manufacturer (Well Brain International Ltd.) and comparisons against specifications of legally marketed predicate devices. The country of origin for the data is implied to be Hong Kong, China (where the manufacturer is located), though specific test labs are not detailed. It is retrospective in the sense that the new device's characteristics are compared against existing standards and predicate devices' known specifications.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided and is generally not relevant for this type of 510(k) submission. "Ground truth" in this context is defined by international safety and performance standards (e.g., IEC standards, ASTM standards, AAMI standards) and the specifications of the predicate devices. Compliance with these established standards and equivalence to the predicates serves as the "ground truth" for regulatory clearance.
4. Adjudication Method for the Test Set
This information is not applicable. Adjudication methods (like 2+1, 3+1) are typically used for establishing ground truth in clinical studies involving expert interpretation of medical data (e.g., radiology reads). For a powered muscle stimulator demonstrating substantial equivalence through bench testing, the "adjudication" is essentially the determination by the manufacturer (and subsequently, the FDA) of whether the device meets the referenced standards and is substantially equivalent to the predicates.
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
No, an MRMC comparative effectiveness study was not done. This type of study is specifically relevant for AI-powered diagnostic devices that assist human readers (e.g., radiologists interpreting images). The GYMFORM® ABS&CORE is a powered muscle stimulator, and its submission focuses on electrical safety, performance, and functional equivalence, not on improving human reader performance with AI.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
No, a standalone algorithm performance study was not done or is not applicable. The device is hardware-based with integral software/firmware for control, but it's not an "algorithm only" device in the diagnostic AI sense. Its function is direct muscle stimulation, not data analysis or diagnosis.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this submission is established through:
- Compliance with recognized international standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-10, FDA Guidance documents (e.g., for software, powered muscle stimulators), ASTM F 1980-07, AAMI EC 12_2000_(R) 2010 electrodes, ISO10993-5, ISO10993-10.
- Specifications and performance of legally marketed predicate devices: Gymform® ABS-A-ROUND (K130074) and Contour Technology Muscle Stimulator (K111476).
The ultimate ground truth is the determination of substantial equivalence to these predicates, which implies equivalent safety and effectiveness.
8. The Sample Size for the Training Set
This information is not applicable in the context of this 510(k) submission. A "training set" refers to data used to train machine learning models. This device is a traditional medical device (powered muscle stimulator) and does not involve AI or machine learning that would require a training set.
9. How the Ground Truth for the Training Set Was Established
As no training set (for AI/ML) is mentioned or relevant to this device, the question of how its ground truth was established is not applicable.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 11, 2015
Well Brain International, Ltd. Victor K. Wai Managing Director Room 03, 14/F, Fook Yip Bldg. 53-57 Kwai Fung Crescent Kwai Chung, N. T. Hong Kong, China
Re: K142055
Trade/Device Name: GYMFORM® ABS&CORE, Model: VDPGYCSET0042 Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: NGX Dated: April 3, 2015 Received: April 10, 2015
Dear Mr. Wai.
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. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device
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related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Felipe Aquel -S
Carlos L. Peña, PhD, MS for Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K142055
Device Name GYMFORM® ABS&CORE, Model: VDPGYCSET0042
Indications for Use (Describe)
GYMFORM®ABS& CORE is intended to stimulate healthy muscles in order to improve or facilitate muscle performance. The ABS& CORE may be considered a technique or method for muscle training. 2-area belt is intended for use on the muscles in abdomen or lower back separately. Mini belt is intended for use on the muscles in arms, legs, thighs or buttocks areas separately.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
| | Prescription Use (Part 21 CFR 801 Subpart D)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
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Sponsor: Well Brain International Ltd. Subject Device: GYMFORM®ABS& CORE, Model: VDPGYCSET0042 File No.: 510(k) submission report (V1.0), Chapter 5
Chapter 5. 510(k) Summary
510(k) Summary
This summary of 510(K) safety and effectiveness information is being submitted in accordance with the requirement of 21 CFR 807.92.
1. Date of the summary prepared: May 8, 2015
2. Submitter's Information
- 510(k) Owner's Name: Well Brain International Ltd. �
- � Establishment Registration Number: 3004950644
- � Address: Room 03, 14/F, Fook Yip Bldg., 53-57 Kwai Fung Crescent, Kwai Chung, N. T. Hong Kong, China
- � Phone: (852) 2619-0833
- � Fax: (852) 2429-0960
- � Contact Person: Victor K Wai
- Email: victor@wellbrain-intl.com �
3. Subject Device Information
- GYMFORM®ABS & CORE, Model: VDPGYCSET0042 � Trade Name:
- Powered muscle stimulator Common Name: �
- Stimulator, Muscle, Powered, For muscle conditioning � Classification name:
- Physical Medicine Review Panel: �
- NGX Product Code: �
- ll Regulation Class: �
- 890:5850 � Regulation Number:
4. Predicate Device Information
| PredicateDevice | Predicate Device I | Predicate Device II |
|---|---|---|
| Sponsor | Well Brain International Ltd. | Contour Technology |
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| PredicateDevice | Predicate Device I | Predicate Device II |
|---|---|---|
| Device Name | Gymform® ABS-A-ROUND,model: VDPGYCIND0016 | Contour TechnologyMuscle Stimulator |
| 510(k) Number | K130074 | K111476 |
| Product Code | NGX | NGX |
| RegulationNumber | 21 CFR 890.5850 | 21 CFR 890.5850 |
| RegulationClass | II | II |
5. Device Description
GYMFORM® ABS&CORE is a two channels battery operated muscle stimulation system specifically designed to stimulation the muscles.
The 2-area belt is intended for use on the muscles in abdomen or lower back separately.
Mini belt is intended for use on the muscles in arms, legs, thighs and buttocks areas separately.
It is comprised of a console for signal generation, two belts (2-area belt and mini belt) for fixation, and electrode pads for signal connection to skin. The electrode pads are replaceable.
Power is derived from 2 "AAA" batteries located in a compartment protected by a removable battery cover. There is no current passed from side to side. The user cannot access the wiring or connectors within the belt.
The stimulator sends gentle electrical current to targeted muscle group through the electrodes placed on the skin. The parameters of the device are controlled by the buttons. Its intensity level can be adjustable by user.
6. Intended Use / Indications for Use
GYMFORM®ABS& CORE is intended to stimulate healthy muscles in order to improve or facilitate muscle performance. The ABS& CORE may be considered a technique or method for muscle training. 2-area belt is intended for use on the muscles in abdomen or lower back separately. Mini belt is intended for use on the muscles in arms, legs, thighs or buttocks areas separately.
7. Test Summary
ABS & CORE has been evaluated the safety and performance by lab bench testing as following:
- Electrical safety test according to IEC 60601-1 and IEC 60601-2-10 standards �
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- � Electromagnetic compatibility test according to IEC 60601-1-2 standard
- � Software verification and validation test according to the requirements of the FDA "Guidance for Pre Market Submissions and for Software Contained in Medical Devices"
- � Waveform test report to verify the output specifications of the device according to IEC 60601-2-10 and Guidance for Powered Muscle Stimulator.
- � Dispersion test and Shelf test according to ASTM F 1980-07, Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devicesand Guidance: Shelf Life of Medical Device.
- � Adhesion test according to Section 5.4 of AAMI EC 12_2000_(R) 2010 Disposable ECG electrodes.
Comparison to predicate device and conclusion 8.
The technological characteristics, features, specifications, materials, mode of operation, and intended use of GYMFORM®ABS & CORE is substantially equivalent to the predicate devices quoted above.
The differences between the subject device and predicate devices do not raise new issues of safety or effectiveness.
| ElementsofComparison | Subject Device | Predicate Device I | Predicate Device II | Remark | |
|---|---|---|---|---|---|
| Basic Unit Characteristics | |||||
| Device Name andModel | GYMFORM® ABS &CORE, Model:VDPGYCSET0042 | Gymform®ABS-A-ROUND,model:VDPGYCIND0016 | Contour TechnologyMuscle Stimulator | -- | |
| 510 (K) Number | Applying | K130074 | K111476 | -- | |
| Intended Use | GYMFORM®ABS&CORE is intended tostimulate healthymuscles in order toimprove or facilitatemuscleperformance. TheABS& CORE maybe considered atechnique or methodfor muscle training. | Intended Use /Indications for Use:TheGYMFORM®ABS-A-ROUND isintended tostimulate healthymuscles in order toimprove or facilitatemuscleperformance. TheABS-A-ROUND | The ContourTechnology MuscleStimulator isintended to stimulatehealthy muscles inorder to improve orfacilitate muscleperformance. TheContour TechnologyMuscle Stimulatormay therefore beconsidered a | SE | |
| Elements of Comparison | Subject Device | Predicate Device I | Predicate Device II | Remark | |
| intended for use onthe muscles inabdomen or lowerback separately.Mini belt is intendedfor use on themuscles in arms,legs, thighs orbuttocks areasseparately. | may be considereda technique ormethod for muscletraining.The 3-area belt isintended for use onthe muscles inabdomen, left waistand right waistalternately.The Mini belt isintended for use onthe muscles inarms, legs (lowerextremities), thighsand buttocks areasseparately. | technique or methodfor muscle training.The ContourTechnology MuscleStimulator Ab Beltaccessory isintended for use onabdominal musclesonly forstrengthening andtoning of abdominalmuscles.The ContourTechnology MuscleStimulator BackPadaccessory isintended for use onthe lower backmuscles only. | |||
| Stimulated muscles | Abdomen, lowerback, arms, legs,thighs and buttocks | Abdomen, lowerback, arms, legs,thighs and buttocks | Abdomen, lowerback | SE | |
| Power Sources | 2 x 1.5V AAAbatteries | 3 x 1.5V AAAbatteries | 4 x 1.5V AAAbatteries | SENote 1 | |
| Method of LineCurrent Isolation | Battery Supply N/A | Battery Supply N/A | Battery Supply N/A | SE | |
| PatientLeakageCurrent | NormalCondition | 10μA | 5.8μA | -- | SENote 1 |
| SingleFaultCondition | 50μA | 8.5μA | -- | SENote 1 | |
| Number of Modes | 6 | 6 | -- | SE | |
| Elements ofComparison | Subject Device | Predicate Device I | Predicate Device II | Remark | |
| Number of Channels | 2 | 3 | -- | SENote 1 | |
| -Synchronous orAlternating | Alternating | Alternating | -- | SE | |
| -Method of ChannelIsolation | Press MODE buttonfor 3 seconds | Press FLR button | -- | SENote 1 | |
| Number IntensityLevel | 31 steps | 99 steps | -- | SENote 1 | |
| Regulated Current orRegulated Voltage | Regulated Voltage | Regulated Voltage | -- | SE | |
| Software/Firmware/Microprocessor control | Yes | Yes | -- | SE | |
| Automatic OverloadTrip | No | No | -- | SE | |
| Automatic No-loadTrip | Yes. | Yes. | -- | SE | |
| Automatic Shut Off | Yes. | Yes | -- | SE | |
| Patient OverrideControl | Yes | Yes | -- | SE | |
| Indicator On/Off Status | Yes | Yes | -- | SE | |
| Indicator Low Battery | Yes | Yes | -- | SE | |
| Display Voltage/Current Level | Yes | No | -- | SE | |
| Timer Range | Default time is 10minutes | Default time is 19minutes | -- | SENote 1 | |
| Console weight | 50g(Withoutbatteries) | 70g (Withoutbatteries) | -- | SENote 1 | |
| Accessories weight | Big belt: 150gSmall belt: 65gElectrode pad: 15gCarry bag: 60g | 3-area belt: 310gMini belt: 25gElectrode pad (big):40gElectrode pad | -- | SENote 1 | |
| Elementsof | Subject Device | Predicate Device I | Predicate Device II | Remark | |
| Comparison | |||||
| (small): 26g | |||||
| Console dimensions | 100 mm(L) x 68 mm(W) x 24.5 mm (H) | 91.8 mm(L) x 25.5 mm (W) x82 mm (H) | -- | SENote 1 | |
| Electrodepaddimension | 40 mm (L) x 70 mm(W) x 3mm (H) | Small: 33.0 cm²Big: 34.5 cm² | 40.5 cm² | SENote 1 | |
| HousingMaterialsand Construction | Console: ABS plasticBelt: PolyesterElectrode pads:Glycerine,Polyacrylic acid,Water and Salt | Console: ABS plasticBelt: PolyesterElectrode pads:Glycerine,Polyacrylic acid,Water and Salt | -- | SE | |
| Output Specification | |||||
| Waveform | Symmetrical | Symmetrical | -- | SE | |
| Shape | Rectangular | Rectangular | -- | SE | |
| Maximum OutputVoltage(Vpeak-topeak)(+/- 10%) | 132V @ 500Ω138V @ 2kΩ140V @ 10kΩ | 108V @ 500Ω124V @ 2kΩ126V @ 10kΩ | -- | SENote 2 | |
| Maximum CurrentDensity(Ipeak-topeak) | 264mA @ 500Ω69mA @ 2kΩ14mA @ 10kΩ | 216mA @ 500Ω62mA @ 2kΩ12.6mA @ 10kΩ | -- | SENote 2 | |
| Frequency range | 2 Hz, 10 Hz, 50 Hz,90 Hz, 120 Hz | 2 Hz, 10 Hz, 50 Hz,90 Hz, 120 Hz | 1 to 120 Hz | SENote 2 | |
| Pulse width range | 108μs / 124μs | 100 μs / 120 μs | -- | SENote 2 | |
| ElementsofComparison | Subject Device | Predicate Device I | Predicate Device II | Remark | |
| Pulse duration(Onlychanges with themode) | Mode 1: 500ms;Mode 2: 11.1ms;Mode 3: 8.3ms;Mode 4:Front 90s: 11.1ms;Back 90s: 8.3ms;Mode 5: 100ms;Mode 6: 20ms | Mode 1: 500ms;Mode 2: 11.1ms;Mode 3: 8.33ms;Mode 4:Front 90s: 11.1ms;Back 90s: 8.33ms;Mode 5: 100ms;Mode 6: 20ms | 340 µs | SENote 2 | |
| Phase duration(Onlychanges with themode) | Mode 1: Notapplicable(Continuous pulse)Mode 2: 2sMode 3: 2sMode 4: 2sMode 5: 10sMode 6: 16s | Mode 1: Notapplicable(Continuous pulse)Mode 2: 2sMode 3: 2sMode 4: 2sMode 5: 10sMode 6: 16s | -- | SE | |
| Net Charge | 19.2µC@ 500Ω | 15.7µC @ 500Ω | -- | SENote 2 | |
| Maximum PhaseCharge | 16.4µC@ 500Ω | 13.0µC@ 500Ω | -- | SENote 2 | |
| Maximum CurrentDensity | 0.082 mA/cm²@500Ω | 0.057 mA/cm²@500Ω | 0.55 mA/cm² @500Ω | SENote 2 | |
| Maximum PowerDensity | 94.8 μW/cm² @500Ω | 53.8 μW/cm² @500Ω | -- | SENote 2 | |
| ON time | 0.5s | 1s | -- | SENote 2 | |
| OFF time | 0.5s | 1s | -- | SENote 2 | |
| ContractionandRelaxation time | Adjustable, due todifferent modes. | Adjustable, due todifferent modes. | -- | SE | |
| Burst Mode | |||||
| Pulse per burst | 1~397 | 1~397 | -- | SE | |
| Elements of Comparison | Subject Device | Predicate Device I | Predicate Device II | Remark | |
| Bursts per second | 0.125~1 | 0.125~1 | -- | SE | |
| Burst Duration(s) | 1~8 | 1~8 | -- | SE | |
| Duty Cycle | 0.02%~1.28% | 0.02%~1.19% | -- | SENote 2 | |
| Additional Features | |||||
| Environment for operating | Temperature: 5 ~ 40°CHumidity: 20 ~65% RH | Temperature: 5 ~ 45°CHumidity: 20 ~65% RH | -- | SE | |
| Environment for storage | Temperature: 0~40° CHumidity: 10 ~90% RH | Temperature: 5 ~ 45°CHumidity: 20 ~65% RH | -- | SE | |
| Biocompatibility | All user directly contacting materials are compliance with ISO10993-5 and ISO10993-10 requirements. | All user directly contacting materials are compliance with ISO10993-5 and ISO10993-10 requirements. | All user directly contacting materials are compliance with ISO10993-5 and ISO10993-10 requirements. | SE | |
| Electrical Safety | Comply with IEC 60601-1 and IEC 60601-2-10 | Comply with IEC 60601-1 and IEC 60601-2-10 | Comply with IEC 60601-1 and IEC 60601-2-10 | SE | |
| EMC | Comply with IEC 60601-1-2 | Comply with IEC 60601-1-2 | Comply with IEC 60601-1-2 | SE |
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Well Brain International Ltd. Sponsor: GYMFORM®ABS& CORE, Model: VDPGYCSET0042 Subject Device: File No.: 510(k) submission report (V1.0), Chapter 5
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Well Brain International Ltd. Sponsor: GYMFORM®ABS& CORE, Model: VDPGYCSET0042 Subject Device: File No.: 510(k) submission report (V1.0), Chapter 5
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Well Brain International Ltd. Sponsor: GYMFORM®ABS& CORE, Model: VDPGYCSET0042 Subject Device: File No.: 510(k) submission report (V1.0), Chapter 5
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Well Brain International Ltd. Sponsor: GYMFORM®ABS& CORE, Model: VDPGYCSET0042 Subject Device: File No.: 510(k) submission report (V1.0), Chapter 5
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Well Brain International Ltd. Sponsor: GYMFORM®ABS& CORE, Model: VDPGYCSET0042 Subject Device: File No.: 510(k) submission report (V1.0), Chapter 5
Comparison in Detail(s):
Note 1:
Although the power sources, patient leakage current in normal condition and single fault condition, number of channels, synchronous or alternating, method of channel isolation, number intensity level, timer range console weight, accessories weight, console dimensions, electrode pad dimension of subject device are a
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Sponsor: Well Brain International Ltd. GYMFORM®ABS& CORE, Model: VDPGYCSET0042 Subject Device: File No.: 510(k) submission report (V1.0), Chapter 5
little different from the predicate devices, they are all compliant with requirements of IEC 60601-1, IEC 60601-1-2 and Guidance for Powered Muscle Stimulator. So the differences of the function specifications will not raise any safety or effectiveness issue.
Note 2:
Although the maximum output voltage, maximum current density, frequency range, pulse width range, pulse duration, contraction time, net charge, maximum phase charge, maximum current density, maximum power density, on time, off time, contraction time and duty cycle of subject device are a little different from the predicate devices, they are all compliant with the requirements of IEC 60601-1, IEC 60601-2-10, and Guidance for Powered Muscle Stimulator. So the differences of function specification will not raise any safety or effectiveness issue.
Finial Conclusion:
The subject device "GYMFORM® ABS& CORE" is Substantial Equivalence to the predicate device.
§ 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).