(309 days)
The SM9065 Fitness Belt is indicated for the improvement of muscle tone, for strengthening of muscles and for the development of firmer muscles.
- The big belt is intended for use on the muscles in abdomen.
- The small belt is intended for use on the muscles in arms and thighs areas.
Contraindicated use on injured or otherwise impaired muscles.
Not intended for use in any therapy or for the treatment of any medical conditions or diseases.
SM9065 Fitness Belt is a two channels battery operated muscle stimulation system to achieve the purpose of exercise and relaxation. It is comprised of a main device for signal generation, four belts for fixation, and series electrodes.
The big belt is intended for use on muscles in abdomen. The two small belts are intended for use on muscles in arms and thigh areas.
Power is derived from 2 "AAA" batteries located in a compartment protected by a removable battery cover. The stimulator sends gentle electrical current to targeted muscle group through the electrodes placed on the skin. The parameters of the unit are controlled by the buttons. Its intensity level and frequency level can be adjusted by user.
This document is a 510(k) summary for the SM9065 Fitness Belt, a powered muscle stimulator. It focuses on demonstrating substantial equivalence to already marketed predicate devices rather than presenting a standalone study with acceptance criteria in the typical sense for clinical performance.
Here's a breakdown of the requested information based on the provided text, recognizing the nature of a 510(k) submission for this type of device:
1. Table of Acceptance Criteria and Reported Device Performance
For this specific device (a powered muscle stimulator for muscle toning), direct clinical acceptance criteria like sensitivity/specificity are not presented. Instead, the "acceptance criteria" are compliance with established electrical safety, EMC, and biocompatibility standards, and demonstrating waveform parameters are within acceptable ranges and comparable to predicate devices.
| Acceptance Criteria Category | Specific Standard/Guidance | Subject Device Performance |
|---|---|---|
| Electrical Safety | IEC 60601-1 and IEC 60601-2-10 | Complies with IEC 60601-1 and IEC 60601-2-10 standards. Key parameters include: - Method of Line Current Isolation: Type BF Applied Part - Patient Leakage Current: NC SFC (no specific value, but implicit compliance) - Average DC current through electrodes (device on, no pulses): < 0.01µA |
| Electromagnetic Compatibility (EMC) | IEC 60601-1-2 | Complies with IEC 60601-1-2 standard. |
| Biocompatibility | ISO 10993-5 and ISO 10993-10 | All user directly contacting materials (belt, electrode) are compliant with ISO 10993-5 (Cytotoxicity) and ISO 10993-10 (Sensitization, Irritation or intracutaneous reactivity) requirements. The belt's non-woven fabric was tested, and the electrodes were referenced to a legally marketed device (K132588) that had prior testing. |
| Software Verification & Validation | FDA "Guidance for Pre Market Submissions and for Software Contained in Medical Devices" | Software verification and validation test conducted (no specific metrics provided, but compliance stated). |
| Waveform Parameters | FDA "Guidance Document for Powered Muscle Stimulator 510(k)s" | Waveform test report conducted, verifying output parameters (waveform, shape, voltage, pulse width, frequency, etc.) and output waveforms (for each mode and channel under loads of 500, 2k, and 10k ohms). Specific reported parameters for the subject device include:- Waveform: Pulsed monophasic- Shape: Rectangular- Max Output Voltage: 90V@500Ω, 132V@2KΩ, 170V@10KΩ- Max Output Current: 180mA@500Ω, 66mA@2KΩ, 17mA@10KΩ- Pulse Duration: 200 µs (Constant)- Pulse Frequency: 1 to 50 Hz- Net Charge (per pulse): 16.72µC @ 500Ω- Max Phase Charge: 0.12µC@ 500Ω- Max Average Current: 0.836µA@ 500Ω- Max Current Density: 0.015 mA/cm² @ 500Ω- Max Average Power Density: 6.16 µW/cm²@ 500Ω(These values are compared to predicate devices and deemed compliant with the guidance, despite some differences.) |
| Functional Specifications | IEC 60601-2-10 requirements | (Implicitly met, as stated in Note 3 and 4 of the comparison table that differences in parameters like number of intensity levels, timer range, output voltage/current, etc., "will not raise any safety or effectiveness issue" as they comply with IEC 60601-2-10 and FDA guidance.) |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document describes bench testing against standards, not a clinical trial with a "test set" of patient data. Therefore, the concept of sample size and data provenance in a clinical context does not apply here. The "test set" refers to the device itself being tested according to engineering and safety standards. The document does not specify the number of units tested, but standard compliance typically involves testing representative samples. Data provenance is not applicable for this type of testing.
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 is not applicable. For a 510(k) submission regarding a powered muscle stimulator, and specifically for bench testing against established engineering and safety standards, "ground truth" is defined by the requirements of those standards (e.g., a certain voltage must be output, a certain current limit must not be exceeded). The tests are performed by qualified engineers or technicians in testing facilities, but the "ground truth" itself is the standard's specification, not expert consensus on medical images or clinical outcomes.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. This type of device does not involve expert adjudication as one would find in studies assessing diagnostic accuracy where ground truth is challenging to establish.
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
Not applicable. This is a powered muscle stimulator, not an AI diagnostic or assistance device. No MRMC study was mentioned or would be relevant for this type of device.
6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done
This refers to the performance of the device's hardware and software alone as an electrical stimulator. The document states that bench tests were conducted to verify that the subject device meets all design specifications. These include:
- Electrical safety tests (IEC 60601-1, IEC 60601-2-10)
- Electromagnetic compatibility tests (IEC 60601-1-2)
- Software verification and validation tests
- Waveform tests (verifying output parameters according to FDA guidance)
- Biocompatibility tests (ISO 10993-5, ISO 10993-10)
These tests evaluate the device's inherent performance characteristics, without human interaction other than operating the device for the purpose of testing.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this submission is adherence to recognized electrical safety, biocompatibility, and performance standards (e.g., IEC 60601-1, IEC 60601-1-2, IEC 60601-2-10, ISO 10993 series, and FDA guidance documents for powered muscle stimulators). The device's measured parameters (voltage, current, frequency, etc.) are compared against the limits and specifications defined by these standards and guidance.
8. The sample size for the training set
Not applicable. This device is not an algorithm trained on a dataset. It's a hardware device evaluated against engineering standards.
9. How the ground truth for the training set was established
Not applicable. There is no training set for this device.
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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 eagle with three human profiles incorporated into its design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 5, 2014
Hong Qiang Xing (Shenzhen) Electronics Limited Mr. Xu Jianhua, General Manager 4F, JingCheng Building, Xicheng Industrial Zone, Xixiang Road, Bao'an District Shenzhen, Guangdong Province 518102 CHINA
Re: K133108
Trade/Device Name: Fitness Belt, Model SM9065 Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: NGX Dated: June 20, 2014 Received: July 3, 2014
Dear Mr. Xu Jianhua:
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
{1}------------------------------------------------
CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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" (21CFR 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, Ph.D., M.S. 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) K133108
Device Name Fitness Belt, Model SM9065
Indications for Use (Describe)
The SM9065 Fitness Belt is indicated for the improvement of muscle tone, for strengthening of muscles and for the development of firmer muscles.
-
The big belt is intended for use on the muscles in abdomen.
-
The small belt is intended for use on the muscles in arms and thighs areas.
Contraindicated use on injured or otherwise impaired muscles.
Not intended for use in any therapy or for the treatment of any medical conditions or diseases.
Type of Use (Select one or both, as applicable)
- Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Date: 2014.08.05 10:02:54 -04'00'
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Chapter 6. 510(k) Summary
Date of the summary prepared: August 4, 2014
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. Submitter's Information
- 510(k) Owner's Name: Hong Qiang Xing (Shenzhen) Electronics Limited �
- � Address: 4F.,Jingcheng Building, Xicheng Industrial Zone, Xixiang Road, Bao'an District, Shenzhen, Guangdong Province, PRC
- � Phone: 86-755-26423615
- � Fax: 86-755-29915485-818
- Contact Person (including title): Mr. Xu Jianhua (General Manager) �
- � E-mail: info@sunmas.com
Subject Device Information 2.
- � Trade Name: Fitness Belt, Model: SM9065
- Powered muscle stimulator Common Name: �
- Stimulator, Muscle, Powered, For muscle conditioning Classification name: �
- Physical Medicine Review Panel: �
- NGX Product Code: �
- 2 Regulation Class: �
- 890.5850 Regulation Number: �
3. Predicate Device Information
| Sponsor | Red LemonIncorporation | SPORT-ELEC S.A. |
|---|---|---|
| Device Name | X2ABS DualChannel Fitness Belt | SPORT-ELEC® BodyControl System '4M' |
| 510(k) Number | K102295 | K092476 |
| Product Code | NGX | NGX |
| RegulationNumber | 890.5850 | 890.5850 |
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Hong Qiang Xing (Shenzhen) Electronics Limited Sponsor: Subject Device: Fitness Belt, Model: SM9065 510(k) submission report (V1.0), Chapter 6 510(k) Summary File No.:
| Regulation Class | 2 | 2 |
|---|---|---|
| ------------------ | --- | --- |
4. Device Description
SM9065 Fitness Belt is a two channels battery operated muscle stimulation system to achieve the purpose of exercise and relaxation. It is comprised of a main device for signal generation, four belts for fixation, and series electrodes.
The big belt is intended for use on muscles in abdomen. The two small belts are intended for use on muscles in arms and thigh areas.
Power is derived from 2 "AAA" batteries located in a compartment protected by a removable battery cover. The stimulator sends gentle electrical current to targeted muscle group through the electrodes placed on the skin. The parameters of the unit are controlled by the buttons. Its intensity level and frequency level can be adjusted by user.
5. Intended Use & Indication for Use
Intended Use:
The SM9065 Fitness Belt is intended for use by healthy persons to apply trans-coetaneous electrical muscle stimulation (EMS) through skin contact electrodes for the following purposes:
- Improvement of muscle tone of the muscles in the abdomen, arms and thighs.
Indication for Use:
The SM9065 Fitness Belt is indicated for the improvement of muscle tone, for strengthening of muscles and for the development of firmer muscles.
-
The big belt is intended for use on the muscles in abdomen.
-
The small belt is intended for use on the muscles in arms and thighs areas.
Contraindicated use on injured or otherwise impaired muscles.
Not intended for use in any therapy or for the treatment of any medical conditions or diseases.
6. Design
SM9065 Fitness Belt is a two channels battery operated muscle stimulation system to achieve the purpose of exercise and relaxation. It is comprised of a main device for signal generation, four belts for fixation, and series electrodes.
The big belt is intended for use on muscles in abdomen. The two small belts are intended for use on muscles in arms and thigh areas.
Power is derived from 2 "AAA" batteries located in a compartment protected by a removable battery cover. The stimulator sends gentle electrical current to targeted muscle group through the electrodes placed on
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the skin. The parameters of the unit are controlled by the buttons. Its intensity level and frequency level can be adjusted by user.
7. Materials
There are four user directly contracting components in the subject device as the following list.
| Component of DeviceRequiringBiocompatibility | Material ofComponent | Body ContactCategory(ISO 10993-1) | Contact Duration(ISO 10993-1) |
|---|---|---|---|
| Belt | Non-woven (synthetic)fabric in 100%polyester | Surface-contactingdevice: skin | Maximum 45 minutes(< 24hours) |
| Electrode | -- | Surface-contactingdevice: skin | Maximum 45 minutes(< 24hours) |
The Nature of body contact is surface, skin contact. And the contact duration is less than 24 hours. According to Table 1 - Initial evaluation tests for consideration in ISO 10993-1, the applicable biological effect is:
- � Cytotoxicity
- � Sensitization
- � Irritation or intracutaneous reactivity
The electrodes used in the Fitness Belt (Model: SM9065) are the ones of Top - Rank Adhesive Electrode manufactured by Top - Rank Health Care Equipment Co., Ltd and legally marketed in K132588. So, we do not provide the ISO 10993-5 and ISO 10993-10 test reports on electrodes.
The non-woven fabric of belt used in the Fitness Belt (Model: SM9065) has been tested in accordance with the standards ISO 10993-5, ISO 10993-10.
8. Physical characteristics
| Power Source | 2 x 1.5V AAA batteries |
|---|---|
| Number of channels | Two channels |
| Number of programs | Six modes |
| Output | From 0 V to 90 V |
| Output intensity level | 10 level |
| Frequency | 1~50 Hz |
| Pulse width range | 200µs (Constant) |
| Contraction and relaxation time | Adjustable, due to different modes. (See below "Program Specification Table") |
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| Sponsor: | Hong Qiang Xing (Shenzhen) Electronics Limited |
|---|---|
| Subject Device: | Fitness Belt, Model: SM9065 |
| File No.: | 510(k) submission report (V1.0), Chapter 6 510(k) Summary |
| Treatment time | 30 minutes (default) |
|---|---|
| Indicator display | Indicate the following information: on/off status, modes, intensity &frequency levels and time. |
| Electrode size | Small (one piece): about 56.7 cm²;Big (one piece): about 96.04 cm² |
| Control unit dimension | 106.6 mm (L) x 77.9 mm (W) x 31.3 mm (H) |
| Weight | Control unit (except for batteries): 83 gBig belt: 84 gSmall belt: 49 g x 2 pieceElectrode pad (big): 22 gElectrode pad (small): 14 g x 6 piece |
| Environment foroperation | Temperature: 5~40 °CHumidity: ≤80% RH |
| Environment forstorage | Temperature: 0~45 °CHumidity: ≤93% RH |
9. Safety & EMC Test Summary
SM9065 Fitness Belt has been evaluated the safety and EMC testing as following:
- Electrical safety test according to IEC 60601-1 and IEC 60601-2-10 standards �
- � Electromagnetic compatibility test according to IEC 60601-1-2 standard
10. Non-Clinical Test Conclusion
Bench tests have been conducted to verify that the subject device meets all design specifications as predicate devices per the following:
- � 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 has also been conducted to verify the output parameters (waveform, shape, voltage, pulse width, frequency and so on) and output waveforms (for each mode and each channel under loads of 500, 2k, and 10k ohms) according to the requirements of the FDA "Guidance Document for Powered Muscle Stimulator 510(k)s"
11. Comparison to predicate device and conclusion
The technological characteristics, features, specifications, materials, and intended use of SM9065 Fitness Belt are 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.
| Elements ofComparison | Subject Device | Predicate Device | Remark |
|---|---|---|---|
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| Sponsor: Hong Qiang Xing (Shenzhen) Electronics Limited | |
|---|---|
| Subject Device: Fitness Belt, Model: SM9065 | |
| File No.: 510(k) submission report (V1.0), Chapter 6 510(k) Summary |
| Elements ofComparison | Subject Device | Predicate Device | Remark |
|---|---|---|---|
| Device Name andModel | SM9065 Fitness Belt,Model: SM9065 | X2ABS Dual ChannelFitness Belt | -- |
| 510(k) Number | K133108 | K102295 | -- |
| Manufacturer | Hong Qiang Xing(Shenzhen) ElectronicsLimited | Leto EnterprisesIncorporation | SPORT-ELEC S.A. |
| Intended Use | The SM9065 FitnessBelt is intended for useby healthy persons toapply trans-coetaneouselectrical musclestimulation (EMS)through skin contactelectrodes for thefollowing purposes:- Improvement of muscletone of the muscles inthe abdomen, arms andthighs. | The X2ABS Dual ChannelFitness Belt is intendedfor use by healthy personsto apply trans-coetaneouselectrical musclestimulation (EMS) throughskin contact electrodes forthe following purposes:- Improvement of muscletone of the muscles in theabdomen. | The Body Control '4M'is intended for use byhealthy persons toapply trans-coetaneous electricalmuscle stimulation(EMS) through skincontact electrodes forthe following purposes.- Improvement ofmuscle tone andfirmness, forstrengthening musclesin arms, abdomen,thighs and buttocksareas.SENote 1 |
| Basic Unit Characteristics | |||
| Power Source(s) | 2 x 1.5V AAA batteries | 2 x 1.5V AAA batteries | 3 x 1.5V AA batteriesSENote 2 |
| -Method of LineCurrent Isolation | Type BF Applied Part | Type BF Applied Part | Type BF Applied Part SE |
| PatientLeakageCurrent | NCSFC | 0.586μA24.017μA | 3μA8μASENote 2 |
| Average DCcurrent throughelectrodes whendevice is on butno pulses arebeing applied | < 0.01μA | < 0.01μA | < 0.01μASE |
| Number ofOutput Channels: | Two channels | Two channels | Two channelsSE |
| Number of OutputModes | 6 modes | 8 modes | 4 modesSENote 3 |
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| Sponsor: Hong Qiang Xing (Shenzhen) Electronics Limited | |
|---|---|
| Subject Device: Fitness Belt, Model: SM9065 | |
| File No.: 510(k) submission report (V1.0), Chapter 6 510(k) Summary |
| Elements ofComparison | Subject Device | Predicate Device | Remark | ||
|---|---|---|---|---|---|
| Output IntensityLevel | 10 steps | 28 steps | -- | SENote 3 | |
| Synchronous orAlternating? | Alternating | Alternating | -- | SE | |
| Method ofChannel Isolation | Voltage Isolation | Voltage Isolation | -- | SE | |
| Regulated Currentor RegulatedVoltage? | Current Control | Current Control | -- | SE | |
| Software/Firmware/MicroprocessorControl? | Yes | Yes | Yes | SE | |
| AutomaticOverload Trip | Yes | Yes | Yes | SE | |
| Automatic No-Load Trip | Yes | Yes | Yes | SE | |
| Automatic ShutOff | Yes | Yes | Yes | SE | |
| Patient OverrideControl | Yes | Yes | Yes | SE | |
| IndicatorDisplay | On/OffStatus | Yes | Yes | No | SENote 3 |
| LowBattery | No | Yes | No | SENote 3 | |
| Voltage/CurrentLevel | No | No | No | SE | |
| Timer Range | Default time is 30minutes | Default time is 10minutes, minimum time is5 minutes | -- | SENote 3 | |
| LCD display | Indicate the followinginformation: on/offstatus, modes, intensity& frequency levels andtime. | Indicate the followinginformation: Sound on/off,Keylock, Low battery,Channel indication,Intensity level, Modeselection. | Indicate the followinginformation: indicatorof power, indicator ofelectrodes or ofcontact, indicator ofweak and/or defectivebattery, indicatorabsence contact belt,indicator of the | SE |
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| Sponsor: | Hong Qiang Xing (Shenzhen) Electronics Limited |
|---|---|
| Subject Device: | Fitness Belt, Model: SM9065 |
| File No.: | 510(k) submission report (V1.0), Chapter 6 510(k) Summary |
| Elements ofComparison | Subject Device | Predicate Device | Remark | |
|---|---|---|---|---|
| programs. | ||||
| Compliance withVoluntaryStandards | YesComply with IEC 60601-1 and IEC 60601-2-10,IEC 60601-1-2 | YesComply with IEC 60601-1and IEC 60601-2-10, IEC60601-1-2 | YesComply with IEC60601-1 and IEC60601-2-10, IEC60601-1-2 | SE |
| Compliance* with21 CFR 898 | Yes | Yes | Yes | SE |
| Weight | Control unit (except forbatteries): 83 gBig belt: 84 gSmall belt: 49 g x 2pieceElectrode pad (big): 22 gElectrode pad (small):14 g x 6 piece | 81.2g | 106g | SENote 3 |
| Dimensions | 106.6 mm (L) x 77.9 mm(W) x 31.3 mm (H) | 82mm (L) x 62mm (W) x23mm (H) | 69mm (L) x 43mm (W)x 87mm (H) | SENote 3 |
| Electrode Size | Small: about 56.7 cm2;Big: about 96.04 cm2 | 32 cm2 | Small: 25 cm2Big: 32 cm2 | SENote 4 |
| Housing Materialsand Construction | ABS plastic | ABS plastic | ABS plastic | SE |
| Output Specifications | ||||
| Waveform | Pulsed monophasic | Pulsed monophasic | Pulsed monophasic | SE |
| Shape | Rectangular | Rectangular | Rectangular | SE |
| Maximum OutputVoltage(+/- 10%) | 90V@ 500Ω | 30V@ 500Ω | -- | SENote 4 |
| 132V@ 2KΩ | 90V@ 2KΩ | -- | ||
| 170V@ 10KΩ | 150V@ 10KΩ | -- | ||
| Maximum OutputCurrent(+/- 10%) | 180mA@ 500Ω | 60mA@ 500Ω | -- | SENote 4 |
| 66mA@ 2KΩ | 45mA@ 2KΩ | -- | ||
| 17mA@ 10KΩ | 15mA@10KΩ | -- | ||
| Pulse Duration | 200 µs (Constant) | 220 µs (Constant) | 200 µs (Constant) | SENote 4 |
| Pulse frequency | 1 to 50 Hz | 8.5 to 64 Hz | 50 to 70 Hz | SENote 4 |
| Net Charge (perpulse) | 16.72µC @ 500Ω | 16.0µC @ 500Ω | -- | SENote 4 |
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| Sponsor: | Hong Qiang Xing (Shenzhen) Electronics Limited |
|---|---|
| Subject Device: | Fitness Belt, Model: SM9065 |
| File No.: | 510(k) submission report (V1.0), Chapter 6 510(k) Summary |
| Elements ofComparison | Subject Device | Predicate Device | Remark |
|---|---|---|---|
| Maximum PhaseCharge | 0.12µC@ 500Ω | 13.2μC@ 500Ω | SENote 4 |
| MaximumAverage Current | 0.836µA@ 500Ω | 1.024μΑ@ 500Ω | SENote 4 |
| Maximum CurrentDensity(r.m.s ) | $I_{AVR} = C F_{Max}$ WhereC= Charge, F=Maximum Frequency$I_{AVR} = 16.72µC x 50Hz =$ $836 µA = 0.836 mA$ | $I_{AVR} = C F_{Max}$ WhereC= Charge, F= MaximumFrequency$I_{AVR} = 16.0µC x 64Hz =$ $1024μA = 1.024mA$ | SENote 4 |
| Max Current Density= IAVR / Square of oneelectrode= 0.836 mA / 56.7 cm²= 0.015 (mA/cm²) | Max Current Density= IAVR / Square of oneelectrode= 1.024mA / 32.0cm²= 0.032 (mA/cm²) | ||
| 0.015 mA/cm² @ 500Ω(for the smallest sizeelectrode about 56.7cm²) | 0.032 mA/cm² @ 500Ω(for the smallest sizeelectrode 32.0 cm²) | ||
| MaximumAverage PowerDensity | Max Power Density= $I_{AVR}^2$ R / Square of oneelectrode= (0.836mA) ² x 500Ω /56.7cm²= 6.16 µW/cm²<0.25(W/cm²) | Max Power Density= $I_{AVR}^2$ R / Square of oneelectrode= (1.024mA) ² x 500Ω /32.0cm²= 16.4 µW/cm²<0.25(W/cm²) | SENote 4 |
| 6.16 µW/cm²@ 500Ω | 16.4 µW/cm²@500Ω | ||
| Burst Mode | |||
| a. Pulse per burst | Mode 1 | 310 - 2500 | SENote 4 |
| Mode 2 | 10 - 124 | ||
| Mode 3 | 61 - 686 | ||
| Mode 4 | 81 - 820 | ||
| Mode 5 | 81 - 820 | ||
| Mode 6 | 127.5 | ||
| b. Bursts persecond | Mode 1 | 2 -16 | SENote 4 |
| Mode 2 | 0.32 - 4.16 | ||
| Mode 3 | 0.02 - 0.27 | ||
| Mode 4 | 0.018 - 0.22 | ||
| Mode 5 | 0.018 - 0.22 |
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| Sponsor: | Hong Qiang Xing (Shenzhen) Electronics Limited |
|---|---|
| Subject Device: | Fitness Belt, Model: SM9065 |
| File No.: | 510(k) submission report (V1.0), Chapter 6 510(k) Summary |
| Elements ofComparison | Subject Device | Predicate Device | Remark | |
|---|---|---|---|---|
| Mode 6 | 39.7 | |||
| c. Burst duration(unit: ms) | Mode 1 | 62 - 500 | -- | SENote 4 |
| Mode 2 | 2 - 24.8 | -- | ||
| Mode 3 | 12.2 - 137 | -- | ||
| Mode 4 | 16.2 - 163.8 | -- | ||
| Mode 5 | 16.2 - 163.8 | -- | ||
| Mode 6 | 25.2 | -- | ||
| d. Duty Cycle | Mode 1 | 100% | -- | SENote 4 |
| Mode 2 | 0.27% -0.30% | -- | ||
| Mode 3 | 0.30% -0.32% | -- | ||
| Mode 4 | 0.25%-0.36% | -- | ||
| Mode 5 | 0.25%-0.36% | -- | ||
| Mode 6 | 100% | -- | ||
| ON Time | 1s | 2s | 2.5s | SENote 4 |
| OFF Time | 1s | 2s | 2.5s | SENote 4 |
| Contraction andRelaxation time | Adjusted by FRE-UPand FRE-DOWNbuttons, due to differentfrequencies. | Adjustable, due todifferent modes. | Adjustable, due todifferent modes. | SE |
| Additional Features | ||||
| Environment foroperating | Temperature: 5 ~ 40° CHumidity: ≤80% RH | Temperature: 5 ~ 40° CHumidity: 20 ~ 65% RH | Temperature: 5 ~ 45° CHumidity: 20 ~ 65% RH | SENote 2 |
| Environment forstorage | Temperature: 0 ~ 45° CHumidity: ≤93% RH | Temperature: 0 ~ 40° CHumidity: 10 ~ 90% RH | Temperature: 0 ~ 45° CHumidity: 10 ~ 90% RH | SENote 2 |
| Standards | ||||
| Biocompatibility | All user directlycontacting materials arecompliance withISO10993-5 and | All user directly contactingmaterials are compliancewith ISO10993-5 andISO10993-10 | All user directlycontacting materialsare compliance withISO10993-5 and | SE |
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| Sponsor: | Hong Qiang Xing (Shenzhen) Electronics Limited |
|---|---|
| Subject Device: | Fitness Belt, Model: SM9065 |
| File No.: | 510(k) submission report (V1.0), Chapter 6 510(k) Summary |
| Elements ofComparison | Subject Device | Predicate Device | Remark |
|---|---|---|---|
| ISO10993-10requirements. | ISO10993-10requirements. | ||
| Electrical Safety | Comply with IEC 60601-1 and IEC 60601-2-10 | Comply with IEC 60601-1and IEC 60601-2-10 | SE |
| EMC | Comply with IEC 60601-1-2 | Comply with IEC 60601-1-2 | SE |
Comparison in Detail(s):
Note 1:
Although the muscles for intended use of subject device are different from predicate devices, we can find that the predicate devices can also be used on the same muscles according to the device description of 510(k) summary. So the subject device and predicate devices have the same intended use aspect.
Note 2:
Although the "Power Source(s)", "Patient Leakage Current", "Average DC current through electrodes when device is on but no pulses are being applied", "Operating Environment", "Storage Environment" are a little different from the predicate devices, they all comply with IEC 60601-1 requirements. So the differences will not raise any safety or effectiveness issue.
Note 3:
Although the " Number of Output Intensity Level", " Method of Channel Isolation", " Timer Range", "Weight", "Dimensions" and "the electrode size" of subject device are different from the predicate devices, they are all comply with IEC 60601-2-10 requirements. So the differences of the function specifications will not raise any safety or effectiveness issue.
Note 4:
Although the "Maximum Output Voltage", "Maximum Output Current", "Pulse Duration", "Maximum pulse frequency", "Net Charge (per pulse)", "Maximum Phase Charge", "Maximum Average Current", "Maximum Current Density", "Maximum Average Power Density of subject device", "Burst Mode" "ON Time" and "OFF Time" are a little different from the predicate devices, they all comply with IEC 60601-2-10 requirement, FDA guidance requirement for Transcutaneous Electrical Nerve Stimulator for Pain Relief and FDA guidance requirement for Powered Muscle Stimulator for Muscle Conditioning. So the differences of function specification will not raise any safety or effectiveness issue.
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Conclusion
The SM9065 Fitness Belt was evaluated with Safety, EMC, Biocompatibility and Waveform Test. The conclusions from testing of the SM9065 Fitness Belt demonstrate that the device is as safe and effective as the legally marketed 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).