(315 days)
To be used to stimulate healthy muscles in order to improve and facilitate muscle performance.
MC0485 EMS Belt is a one channel battery operated muscle stimulation system specifically designed to exercise the abdominal muscles. It is comprised of an electronic stimulator module for signal generation, a belt for fixation, and four electrode pads for signal connection to skin. The built-in electrode pads are located on the inner surface of the belt. Power is derived from 3 batteries located in a compartment protected by a removable battery cover for the EMS Belt. 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 area through the electrode pads placed on the skin. The parameters of the EMS Belt are controlled by the buttons on the controller and are displayed by the LCD on the controller. Its intensity level can be adjustable by user.
This document is a 510(k) Pre-market Notification for the EMS Belt (Model: MC0485). It focuses on demonstrating substantial equivalence to predicate devices, rather than establishing acceptance criteria and conducting a primary study to prove the device meets these criteria in the context of clinical performance or diagnostic efficacy.
Therefore, the requested information regarding acceptance criteria, reported device performance in a clinical study, sample sizes, data provenance, expert participation, adjudication methods, MRMC studies, standalone algorithm performance, and training set details for a study proving the device meets acceptance criteria cannot be extracted directly from this document. This K183103 submission is for a powered muscle stimulator and primarily relies on comparison to predicate devices and adherence to recognized standards for safety and electrical performance.
However, I can extract the information presented in the document regarding the device's technical specifications and the testing performed to demonstrate safety and performance as part of the substantial equivalence claim.
Here's a breakdown of the relevant information from the provided text, addressing the closest applicable aspects of your request:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not present "acceptance criteria" in the typical sense of a clinical performance study (e.g., sensitivity, specificity for a diagnostic device). Instead, it demonstrates compliance with recognized standards and similarity to predicate devices' specifications. The "performance" here refers to meeting these standards and having comparable technical characteristics.
| Acceptance Criteria (Compliance/Similarity) | Reported Device Performance (EMS Belt/MC0485) |
|---|---|
| Biocompatibility: | |
| Compliance with ISO 10993-5 (In Vitro Cytotoxicity) | Passed |
| Compliance with ISO 10993-10 (Irritation and Skin Sensitization) | Passed |
| EMC and Electrical Safety: | |
| Compliance with IEC 60601-1-2 (Electromagnetic compatibility) | Passed |
| Compliance with IEC 60601-1 (Basic safety and essential performance) | Passed |
| Compliance with IEC 60601-1-11 (Home Healthcare Environment) | Passed |
| Compliance with IEC 60601-2-10 (Nerve and muscle stimulators) | Passed |
| Software Verification and Validation: | |
| Meets software requirement specifications and mitigates hazards | All software requirement specifications are met and all software hazards have been mitigated to acceptable risk levels. (Documentation submitted consistent with moderate level of concern). |
| Electrode Pad Performance: | |
| Current dispersion and shelf-life verification (per FDA Guidance & ASTM F1980-07) | Verified |
| Waveform and Output Specifications: | |
| Compliance with FDA Guidance for Powered Muscle Stimulator 510(k)s | Verified (Output specifications are a "little different" from predicates but comply with IEC 60601-1, IEC 60601-2-10, and FDA Guidance, not raising new safety/effectiveness issues. Specific values are detailed in the comparison table of a previous section, but are noted as being within acceptable ranges set by standards rather than against explicit "acceptance criteria" of a study.) |
| Technical Specifications (Comparison to Predicates - highlighted differences and perceived equivalence): | |
| Product Code: NGX | NGX (Similar to prednisone's NUH, NGX. Note 1 states this is within the predicate devices' classification and does not affect intended use or normal use.) |
| Power Supply: 4.5V (3 x 1.5V Alkaline batteries) | Different from some predicates (adaptor, rechargeable battery) but "do not raise new questions of safety and effectiveness." (Note 2) |
| Number of Output Modes: 7 | Different from predicates (10, 35/15, 25, 1) but "do not raise new questions of safety and effectiveness." (Note 2) |
| Number of Output Channels: 1 | Different from predicates (2, 2, 2, 1) but "do not raise new questions of safety and effectiveness." (Note 2) |
| Timer Range: 20min, 25min, 30min, 40min depending on preset program | Different from predicates (5min-30min, 5min-100min, 25min, 1min-60min) but "do not raise new questions of safety and effectiveness." (Note 2) |
| Weight/Dimensions: 310g (without batteries); 78x140x30mm (controller), 430x150x12mm (belt) | Different from predicates but "insignificant in the terms of safety or effectiveness." (Note 3) |
| Housing Materials and Construction: Controller: ABS plastic; Belt: Mutispandex; Electrode pads: TPE | "Consistent completely with the predicate devices" for enclosure. TPE electrodes consistent with K143430. All skin-contacting materials comply with ISO 10993-1, 10993-5, 10993-10. (Note 4) |
| Output Electrical Parameters: Max Output Voltage, Current, Pulse Width, Frequencym, Max Phase Charge, Max Current Density, Max Power Density | "A little different from the predicate devices" but all comply with IEC 60601-1, IEC 60601-2-10, and FDA Guidance, not raising new safety/effectiveness issues. (Note 5) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The submission relies on compliance with international standards and comparison with predicate devices' specifications, not on a clinical test set with human subjects.
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)
This information is not applicable as the submission does not involve a clinical test set requiring expert-established ground truth for a diagnostic or therapeutic efficacy claim.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable as there is no clinical test set requiring adjudication.
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
This information is not applicable. The device is an EMS Belt, not an AI-powered diagnostic or assistive tool, and the submission does not describe an MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. The device is a physical muscle stimulator, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
This information is not applicable. The "ground truth" in this context is adherence to recognized international consensus standards (like ISO and IEC) for biocompatibility, electrical safety, software validation, and product performance/specifications, rather than clinical outcomes or diagnostic accuracy.
8. The sample size for the training set
This information is not applicable. The device is not an AI algorithm that requires a training set. The term "training set" is not relevant to this 510(k) submission.
9. How the ground truth for the training set was established
This information is not applicable for the same reasons as point 8.
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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 square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
September 18, 2019
Dongguan Yingfeng Metal & Plastic Products Co., Ltd % Rain Yip Registered Engineer Feiying Drug & Medical Consulting Technical Service Group Rm. 3005, Area B, Bldg.1, Southward Ruifeng Business Center Guimiao Road Shenzhen, 518000 CN
Re: K183103
Trade/Device Name: EMS Belt (Model: MC0485) Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: NGX Dated: March 14, 2019 Received: August 15, 2019
Dear Rain Yip:
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.
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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 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.
For Vivek Pinto, PhD Director (Acting) DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K183103
Device Name EMS Belt (Model MC0485)
Indications for Use (Describe)
To be used to stimulate healthy muscles in order to improve and facilitate muscle performance.
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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510(k) Summary
''510(k) Summary'' as required by 21 CFR Part 807.92.
Date: 2018-10-26
I. Submitter
Dongguan Yingfeng Metal & Plastic Products Co., Ltd Bianpu District, Lianhu Road, Qiaotou Town, Dongguan City, Guangdong Province, P.R.C
Tel.: +86 769 8334 9883 Tax: +86 769 8345 2882
Zesheng Chen Quality Manager Tel: +86 181 2287 9716 Email: guang@maxcare.com.cn
II. Device
Name of Device/Model: EMS Belt/MC0485 Common or Usual Name: Powered muscle stimulator Classification Name: Stimulator, Muscle, Powered, For muscle conditioning Regulatory Class: II Product Code: NGX Regulation Number: 21 CFR 890.5850
III. Predicate Device
The predicate devices are listed as below:
| Manufacturer | Predicate Device | 510(k) Number | Approval Date |
|---|---|---|---|
| Hivox Biotek Inc. | (Primary) HIVOX OTCElectrical Stimulator/SEM44 | K171803 | Nov. 29, 2017 |
| ShenzhenOSTOTechnology CompanyLimited | Health Expert ElectronicStimulator/AST-300C andAST-300D | K133929 | Nov. 12, 2014 |
| Actegy, Ltd | Revitive IX (OTC)/RIX | K143207 | Mar. 23, 2015 |
Reference device(s):
| Manufacturer | Reference Device | 510(k) Number | Approval Date |
|---|---|---|---|
| -------------- | ------------------ | --------------- | --------------- |
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| Manufacturer | Reference Device | 510(k) Number | Approval Date |
|---|---|---|---|
| EasyMed InstrumentsCo., Ltd. | SmartTENS | K143430 | May 29, 2015 |
IV. Device Description
MC0485 EMS Belt is a one channel battery operated muscle stimulation system specifically designed to exercise the abdominal muscles. It is comprised of an electronic stimulator module for signal generation, a belt for fixation, and four electrode pads for signal connection to skin. The built-in electrode pads are located on the inner surface of the belt.
Power is derived from 3 batteries located in a compartment protected by a removable battery cover for the EMS Belt. 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 area through the electrode pads placed on the skin. The parameters of the EMS Belt are controlled by the buttons on the controller and are displayed by the LCD on the controller. Its intensity level can be adjustable by user.
V. Indications for Use
To be used to stimulate healthy muscles in order to improve and facilitate muscle performance.
VI. Comparison of Technological Characteristics With the Predicate Device
The EMS Belt is substantially equivalent to the predicated device based on intended use, design, specifications and performance. It raises no safety or efficacy concerns when compared to the predicate devices.
Information for predicate device was obtained from publicly available sources, including the 510(k) Summary and device instruction manual. A technical comparison to the predicates is provided below:
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| Comparison Elements | Subject Device | Primary Predicate DeviceK171803 | Predicate DeviceK133929 | Predicate DeviceK143207 | Reference DeviceK143430 | SE | ||
|---|---|---|---|---|---|---|---|---|
| Trade Name/Model | EMS Belt/MC0485 | HIVOX OTC ElectricalStimulator/SEM44 | Health Expert ElectronicStimulator/AST-300C andAST-300D | Revitive IX (OTC)/RIX | SmartTENS | / | ||
| 510(k) Number | To be assigned | K171803 | K133929 | K143207 | K143430 | / | ||
| Regulation Number | 21CFR 890.5850 | 21CFR 882.5890 | 21CFR 882.5890 | 21CFR 882.5890 | 21CFR 882.5890 | SE | ||
| Device Class | II | II | II | II | II | SE | ||
| Product Code | NGX | NUH, NGX | NUH, NGX | NUH, NGX | NUH | SENOTE 1 | ||
| IndicationforUse/Intended Use | To be used tostimulate healthymuscles in order toimprove and facilitatemuscle performance. | SEM44 (EMS): The deviceis designed to be used forstimulate healthy muscles inorder to improve andfacilitate muscleperformance.SEM44 (TENS): The deviceis designed to be used fortemporary relief of painassociated with sore andaching muscles in theshoulder, waist, back, neck,upper extremities (arm),lower extremities (leg),abdomen and bottom due tostrain from exercise ornormal household workactivities. | PMS (Mode 1 | To temporarily increaselocal blood circulation inhealthy leg musclesTo stimulate healthymuscles in order toimprove and facilitatemuscle performance.For temporary relief ofpain associated with soreand aching muscles in theshoulder, waist, back,upper extremities (arms)and lower extremities(legs) due to strain fromexercise or normalhousehold duties | The device is intendedfor the relief of painassociated with soreor aching muscles ofthe low back, arms, orlegs due to stain fromexercise or normalhousehold and workactivities. | SENOTE 1 | ||
| Comparison Elements | Subject Device | Primary Predicate DeviceK171803 | Predicate DeviceK133929 | Predicate DeviceK143207 | Reference DeviceK143430 | SE | ||
| Location for Use | OTC | OTC | OTC | OTC | OTC | SE | ||
| Basic Specifications | ||||||||
| Power Supply | 4.5V (3 × 1.5VAlkaline batteries) | 4.5V (batteries, 3x1.5VAAA) | Adaptor Input: 100-240Vac,50-60Hz, 0.1AOutput: 5Vdc, 1AUnit Input: 5Vdc, 1A | Power adaptorInput: 100-240V, 50/60Hz,0.18AOutput: 5.0VDC, 1.0A | 3.7V rechargeablelithium battery | SENOTE 2 | ||
| Method of Line Current Isolation | N/A | N/A | Type BF Applied Part | Not publicly available | Not publicly available | SE | ||
| PatientLeakageCurrent | Normal Condition | N/A | N/A | AC: 54.5µA, DC: 0.5µA | Not publicly available | Not publicly available | SE | |
| Signal Fault Condition | N/A | N/A | AC: 120.0µA, DC: 0.6μΑ | Not publicly available | Not publicly available | SE | ||
| Number of OutputModes | 10 | EMS: 35TENS: 15 | 25 | 1 | 7 | SENOTE 2 | ||
| Number of OutputChannels | 1 | 2 | 2 | 2 (1 for foot, 1 for bodypads) | 1 | SENOTE 2 | ||
| Synchronous orAlternating? | Alternating | Synchronous | Synchronous | Not publicly available | Not publicly available | SE | ||
| Method of ChannelIsolation | N/A | By electrical circuit andsoftware | Voltage Transform Isolation"BODY▼" and "BODY▼ "buttons for body channel,"SOLE ▲ " and "SOLE ▼ " | Not publicly available | Not publicly available | SE | ||
| Comparison Elements | Subject Device | Primary Predicate DeviceK171803 | Predicate DeviceK133929 | Predicate DeviceK143207 | Reference DeviceK143430 | SE | ||
| buttons for feet channel | ||||||||
| Software/MicroprocessorControl? | /Firmware | Yes | Yes | Yes | Yes | Yes | SE | |
| AutomaticTrip? | Overload | No | Yes | No | Yes | Yes | SE | |
| AutomaticTrip? | No-Load | No | Yes | No | Not publicly available | Yes | SE | |
| Automatic Shut OFF? | Yes | Yes | Yes | Yes | Yes | SE | ||
| PatientControl? | Override | Yes | Yes | Yes | Yes | Yes | SE | |
| On/OffStatus? | Yes | Yes | Yes | Not publicly available | Yes | SE | ||
| IndicatorDisplay | LowBattery? | Yes | Yes | No | Not publicly available | Yes | SE | |
| Voltage/CurrentLevel? | Yes | Yes | Yes | Not publicly available | Yes | SE | ||
| Timer Range | 5min, 10min, 15min,20min, 25min, 30min | 5~100minutes | 25minutes | 1~60minutes | 20min, 25min, 30min,40min depending onpreset program | SENOTE 2 | ||
| CompliancewithVoluntary Standards? | IEC60601-1-2IEC60601-1 | IEC60601-1-2IEC60601-1 | IEC60601-1-2IEC60601-1 | IEC60601-1-2IEC60601-1 | IEC60601-1-2IEC60601-1 | ടല | ||
| Comparison Elements | Subject Device | Primary Predicate DeviceK171803 | Predicate DeviceK133929 | Predicate DeviceK143207 | Reference DeviceK143430 | SE | ||
| IEC60601-11IEC60601-2-10ISO10993-5/10 | IEC60601-2-10ISO10993-5/10 | IEC60601-2-10ISO10993-5/10 | IEC60601-2-10ISO10993-5/10 | IEC60601-2-10ISO10993-5/10 | ||||
| Compliancewith21CFR898 | Yes | Yes | Yes | Yes | Yes | SE | ||
| Weight | 310(withoutgbatteries) | (includingbelt89gclip,without batteries)123g (includingbelt clip,and batteries) | 2kg (without accessories) | 1725g (Without PSU) | 64g | SENOTE 3 | ||
| Dimensions | 78 x 140 x 30mm(controller)430 x 150 x 12mm(belt) | 132ર્ભ્ડXX29.5mm(including belt clip) | 428 x 428.8 x 185mm | φ360 x 75mm | 155.4x 64.4x 19.1mm | SENOTE 3 | ||
| Housing Materials andConstruction | Controller body: ABSplasticBelt: MutispandexElectrode pads: TPE | ABS plastic | ABS plastic | ABS.Casing/bodyfootpads NBR | ABS & TPE | SENOTE 4 | ||
| Biocompatibility | Alluserdirectlycontactingmaterialsare compliance withISO10993-5andISO10993-10. | All user directly contactingmaterials are compliancewithISO10993-5andISO10993-10. | All user directly contactingmaterialsare compliancewithISO10993-5andISO10993-10. | All user directly contactingmaterials are complianceISO10993-5andwithISO10993-10. | directlyAllusercontactingmaterialsare compliance withISO10993-5andISO10993-10. | SE | ||
| Output Specifications | ||||||||
| Waveform | Symmetricalrectangular | Biphasic, square | Pulsedsymmetrical,biphasic, rectangular, withinterphase interval | Pulsedsymmetrical,rectangular | Biphasic rectangularMonophasicrectangular | SENOTE 5 | ||
| @500ΩMaximum | 35 ±10% | 100±10% (50±10%(Vp)) | 44 ±10% | Foot: 20 | 68 | SE | ||
| Comparison Elements | Subject Device | Primary Predicate DeviceK171803 | Predicate DeviceK133929 | Predicate DeviceK143207 | Reference DeviceK143430 | SE | ||
| OutputVoltage(Volts,Vp) | Body: 32 | NOTE 5 | ||||||
| (@2kΩ | 76V±10% | 180±10% (90±10%(Vp)) | 80V ±10% | Foot: 95Body: 118 | 102 | |||
| a,10kΩ | 145V ±10% | 250±10% (125±10%(Vp)) | 112V ±10% | Foot: 138Body: 169 | 110 | |||
| MaximumOutputCurrent(mA) | a,500Ω | 70±10% | 200±10% (100±10%(Ip)) | 88 ±10% | Foot: 40Body: 64 | 133 | ||
| (@2kΩ | 37.5±10% | 90±10% (45±10%(Ip)) | 40±10% | Foot: 48Body: 59 | 21 | SENOTE 5 | ||
| a,10kΩ | 14.5±10% | 25 ±10% (12.5 ±10% (Ip)) | 11.2±10% | Foot: 14Body: 17 | 11 | |||
| Pulse Width | 270us | 50-450ps | 120µs | Foot: 4-7.5usBody: 1.4-33.6us | 50-250ps | SENOTE 5 | ||
| Frequency (Hz) | 1-22Hz | 1-150Hz | 77.3Hz | Foot: 20-53HzBody: 35-46Hz | 1-150Hz | SENOTE 5 | ||
| For Interferential modesonly:Beat-Frequency(Hz) | N/A | N/A | Not publicly available | Not publicly available | Not publicly available | ਫ਼ਜ਼ | ||
| ForMultiphasewaveformsonly | SymmetricalPhases? | Yes | N/A | Not publicly available | Not publicly available | Not publicly available | SE | |
| Phase | N/A | N/A | Not publicly available | Not publicly available | Not publicly available | SE | ||
| Comparison Elements | Subject Device | Primary Predicate DeviceK171803 | Predicate DeviceK133929 | Predicate DeviceK143207 | Reference DeviceK143430 | SE | ||
| Duration | ||||||||
| Maximum PhaseCharge (µC) @500Ω | 23.52 | 0.045 | 12.78 | Foot: 41Body: 15 | 20.01 | SENOTE 5 | ||
| Maximum CurrentDensity@500Ω | 0.13 | 0.667 | 0.235 | Foot: 0.023Body: 0.082 | 0.066 | SENOTE 5 | ||
| Maximum PowerDensity@500Ω | 0.0004 | 0.0046 (average) | 1.38 | Foot: 0.55Body: 1.64 | 2.66 (average) | SENOTE 5 | ||
| BurstMode | Pulses perburst | 1 | 3 | Not publicly available | Foot: 11-256Body: 49-154 | Not publicly available | SE | |
| Bursts persecond | 1/22Hz | 2/60Hz | Not publicly available | Foot: 0.1-0.5Body: 0.2-0.5 | Not publicly available | SE | ||
| Burstduration(seconds) | 0.27ms | 36ms | Not publicly available | Foot: 1.9-8.4sBody: 1.9-6.5s | Not publicly available | SE | ||
| DutyCycle[Line(b) xLine (c)] | N/A | 36ms/390ms | Not publicly available | Foot: 0.56-0.87Body: 0.66-0.87 | Not publicly available | SE | ||
| ON Time (seconds) | 1s | 2s | 0.6s | Foot: 1.92-8.34sBody: 1.92-6.52s | Not publicly available | SE | ||
| OFF Time (seconds) | 3s | 2s | 0.6s | Foot: 1-1.5sBody: 1s | Not publicly available | SE |
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Comparison in details:
NOTE 1: The "Intended Use" of the subject device is the same as the predicate device K171803 SEM44's EMS mode and K133929's PMS (mode 1~8), as well as is within the predicate device K143207. Meanwhile, the "Product Code" of the subject device is within the predicate devices, and these kinds of powered muscle stimulator are classified as NGX in accordance with FDA regulation. This define does not affect the intended use or normal use of the subject device.
NOTE 2: Although the "Power Supply", "Number of Output Modes", "Number of Output Channels", and "Timer Range" of the subject device are a little different from the predicate devices, these differences do not raise new questions of safety and effectiveness.
NOTE 3: Although the "Weight" and "Dimensions" of the subject device are different from the predicate devices, these differences are insignificant in the terms of safety or effectiveness.
NOTE 4: The "Housing Materials and Construction" (materials of skin-contacting components) of the enclosure of the subject device is consistent completely with the predicate devices, and the material of the electrodes is TPE (Thermo-Plastic Elastomers), which is consistent with the electrodes used by K143430. Although their supplier is not sure, they all comply with the requirements of ISO 10993-1 and have been tested and passed the cytotoxicity test, skin sensitization test, and irritation test. So these differences will not raise any safety or effectiveness issue.
NOTE 5: Although the "Maximum Output Voltage", "Maximum Output Current", "Pulse Duration", "Frequency", "Maximum Phase Charge", "Maximum Current Density", and "Maximum Power Density" of the subject device are a little different from the predicate devices, they all comply with the requirements of IEC 60601-1 and IEC 60601-2-10 standard, as well as the Guidance for Powered Muscle Stimulator for Muscle Conditioning. So these differences will not raise any safety or effectiveness issue.
CONCLUSION: The subject device is substantially equivalent to the predicate devices.
VII.Performance Data
The following performance data were provided in support of the substantial equivalence determination.
1) Biocompatibility Testing
The biocompatibility evaluation for the body-contacting components of the EMS Belt was conducted in accordance with the "Use of International Standard ISO 10993-1, 'Biological Evaluation of Medical Devices –Part 1: Evaluation and Testing Within a Risk Management Process, Document Issued on June 16, 2016", as recognized by FDA. The battery of testing was performed to, and passed, including:
-
ISO 10993-5:2009/(R)2014, Biological Evaluation of Medical Devices –Par t 5: Tests for In Vitro Cytotoxicity
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ISO 10993-10:2010. Biological Evaluation of Medical Devices -Par t 10: Tests for Irritation and Skin Sensitization
2) EMC and Electrical Safety
EMC and Electrical safety testing was performed to, and passed, the following standards:
-
IEC 60601-1-2 Medical electrical equipment -Part 1-2: General requirements for basic safety and essential performance -Collateral standard: electromagnetic compatibility
-
IEC 60601-1 Medical electrical equipment -Part 1: General requirements for basic safety and essential performance
-
IEC 60601-1-11 Medical Electrical Equipment -Part 1: General Requirements for Basic Safety and Essential Performance -Collateral Standard: Requirements for Medical Electrical Equipment and Medical Electrical Systems Used in the Home Healthcare Environment
-
IEC 60601-2-10 Medical electrical equipment Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators
3) Software Verification and Validation
Software documentation consistent with moderate level of concern was submitted in this 510(k). System validation testing presented in this 510(k) demonstrated that all software requirement specifications are met and all software hazards have been mitigated to acceptable risk levels.
4) Other Performance Verification
-
The Electrode Pad Performance Test Report has been conducted to verify the current dispersion and shelf-life of the electrodes used by the subject device in the expiration date according to the requirements of the FDA Guidance -Shelf Life of Medical Device and ASTM F1980-07 Standard.
-
The waveform and output test report has also been conducted to verify the output specifications of the subject device according to the FDA Guidance for Powered Muscle Stimulator 510(k)s.
Summary
Based on the above performance as documented in this application. EMS Belt was found to have a safety and effectiveness profile that is similar to the predicate device.
VIII. Conclusions
The subject device EMS Belt is to be concluded substantial equivalent to its predicate devices.
§ 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).