FIT BELT

{0}------------------------------------------------ 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 {2}------------------------------------------------ ### 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' This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ #### 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 Lemon<br>Incorporation | SPORT-ELEC S.A. | |----------------------|------------------------------------|-----------------------------------------| | Device Name | X2ABS Dual<br>Channel Fitness Belt | SPORT-ELEC® Body<br>Control System '4M' | | 510(k) Number | K102295 | K092476 | | Product Code | NGX | NGX | | Regulation<br>Number | 890.5850 | 890.5850 | {4}------------------------------------------------ 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 {5}------------------------------------------------ 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 Device<br>Requiring<br>Biocompatibility | Material of<br>Component | Body Contact<br>Category<br>(ISO 10993-1) | Contact Duration<br>(ISO 10993-1) | |------------------------------------------------------|------------------------------------------------------|-------------------------------------------|-----------------------------------| | Belt | Non-woven (synthetic)<br>fabric in 100%<br>polyester | Surface-contacting<br>device: skin | Maximum 45 minutes<br>(< 24hours) | | Electrode | -- | Surface-contacting<br>device: skin | Maximum 45 minutes<br>(< 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") | {6}------------------------------------------------ | 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 &<br>frequency levels and time. | | Electrode size | Small (one piece): about 56.7 cm²;<br>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 g<br>Big belt: 84 g<br>Small belt: 49 g x 2 piece<br>Electrode pad (big): 22 g<br>Electrode pad (small): 14 g x 6 piece | | Environment for<br>operation | Temperature: 5~40 °C<br>Humidity: ≤80% RH | | Environment for<br>storage | Temperature: 0~45 °C<br>Humidity: ≤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 of<br>Comparison | Subject Device | Predicate Device | Remark | |---------------------------|----------------|------------------|--------| | | | | | {7}------------------------------------------------ | 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 of<br>Comparison | Subject Device | Predicate Device | Remark | |--------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Device Name and<br>Model | SM9065 Fitness Belt,<br>Model: SM9065 | X2ABS Dual Channel<br>Fitness Belt | -- | | 510(k) Number | K133108 | K102295 | -- | | Manufacturer | Hong Qiang Xing<br>(Shenzhen) Electronics<br>Limited | Leto Enterprises<br>Incorporation | SPORT-ELEC S.A. | | Intended Use | The SM9065 Fitness<br>Belt is intended for use<br>by healthy persons to<br>apply trans-coetaneous<br>electrical muscle<br>stimulation (EMS)<br>through skin contact<br>electrodes for the<br>following purposes:<br>- Improvement of muscle<br>tone of the muscles in<br>the abdomen, arms and<br>thighs. | The X2ABS Dual Channel<br>Fitness Belt is intended<br>for use by healthy persons<br>to apply trans-coetaneous<br>electrical muscle<br>stimulation (EMS) through<br>skin contact electrodes for<br>the following purposes:<br>- Improvement of muscle<br>tone of the muscles in the<br>abdomen. | The Body Control '4M'<br>is intended for use by<br>healthy persons to<br>apply trans-<br>coetaneous electrical<br>muscle stimulation<br>(EMS) through skin<br>contact electrodes for<br>the following purposes.<br>- Improvement of<br>muscle tone and<br>firmness, for<br>strengthening muscles<br>in arms, abdomen,<br>thighs and buttocks<br>areas.<br>SE<br>Note 1 | | Basic Unit Characteristics | | | | | Power Source(s) | 2 x 1.5V AAA batteries | 2 x 1.5V AAA batteries | 3 x 1.5V AA batteries<br>SE<br>Note 2 | | -Method of Line<br>Current Isolation | Type BF Applied Part | Type BF Applied Part | Type BF Applied Part SE | | Patient<br>Leakage<br>Current | NC<br>SFC | 0.586μA<br>24.017μA | 3μA<br>8μA<br>SE<br>Note 2 | | Average DC<br>current through<br>electrodes when<br>device is on but<br>no pulses are<br>being applied | < 0.01μA | < 0.01μA | < 0.01μA<br>SE | | Number of<br>Output Channels: | Two channels | Two channels | Two channels<br>SE | | Number of Output<br>Modes | 6 modes | 8 modes | 4 modes<br>SE<br>Note 3 | {8}------------------------------------------------ | 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 of<br>Comparison | Subject Device | Predicate Device | Remark | | | |--------------------------------------------------|--------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|--------------| | Output Intensity<br>Level | 10 steps | 28 steps | -- | SE<br>Note 3 | | | Synchronous or<br>Alternating? | Alternating | Alternating | -- | SE | | | Method of<br>Channel Isolation | Voltage Isolation | Voltage Isolation | -- | SE | | | Regulated Current<br>or Regulated<br>Voltage? | Current Control | Current Control | -- | SE | | | Software/Firmwar<br>e/Microprocessor<br>Control? | Yes | Yes | Yes | SE | | | Automatic<br>Overload Trip | Yes | Yes | Yes | SE | | | Automatic No-<br>Load Trip | Yes | Yes | Yes | SE | | | Automatic Shut<br>Off | Yes | Yes | Yes | SE | | | Patient Override<br>Control | Yes | Yes | Yes | SE | | | Indicator<br>Display | On/Off<br>Status | Yes | Yes | No | SE<br>Note 3 | | | Low<br>Battery | No | Yes | No | SE<br>Note 3 | | | Voltage/<br>Current<br>Level | No | No | No | SE | | Timer Range | Default time is 30<br>minutes | Default time is 10<br>minutes, minimum time is<br>5 minutes | -- | SE<br>Note 3 | | | LCD display | Indicate the following<br>information: on/off<br>status, modes, intensity<br>& frequency levels and<br>time. | Indicate the following<br>information: Sound on/off,<br>Keylock, Low battery,<br>Channel indication,<br>Intensity level, Mode<br>selection. | Indicate the following<br>information: indicator<br>of power, indicator of<br>electrodes or of<br>contact, indicator of<br>weak and/or defective<br>battery, indicator<br>absence contact belt,<br>indicator of the | SE | | {9}------------------------------------------------ | 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 of<br>Comparison | Subject Device | Predicate Device | | Remark | |-------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------|---------------------------------------------------------------------------|--------------| | | | | programs. | | | Compliance with<br>Voluntary<br>Standards | Yes<br>Comply with IEC 60601-<br>1 and IEC 60601-2-10,<br>IEC 60601-1-2 | Yes<br>Comply with IEC 60601-1<br>and IEC 60601-2-10, IEC<br>60601-1-2 | Yes<br>Comply with IEC<br>60601-1 and IEC<br>60601-2-10, IEC<br>60601-1-2 | SE | | Compliance* with<br>21 CFR 898 | Yes | Yes | Yes | SE | | Weight | Control unit (except for<br>batteries): 83 g<br>Big belt: 84 g<br>Small belt: 49 g x 2<br>piece<br>Electrode pad (big): 22 g<br>Electrode pad (small):<br>14 g x 6 piece | 81.2g | 106g | SE<br>Note 3 | | Dimensions | 106.6 mm (L) x 77.9 mm<br>(W) x 31.3 mm (H) | 82mm (L) x 62mm (W) x<br>23mm (H) | 69mm (L) x 43mm (W)<br>x 87mm (H) | SE<br>Note 3 | | Electrode Size | Small: about 56.7 cm2;<br>Big: about 96.04 cm2 | 32 cm2 | Small: 25 cm2<br>Big: 32 cm2 | SE<br>Note 4 | | Housing Materials<br>and Construction | ABS plastic | ABS plastic | ABS plastic | SE | | Output Specifications | | | | | | Waveform | Pulsed monophasic | Pulsed monophasic | Pulsed monophasic | SE | | Shape | Rectangular | Rectangular | Rectangular | SE | | Maximum Output<br>Voltage(+/- 10%) | 90V@ 500Ω | 30V@ 500Ω | -- | SE<br>Note 4 | | | 132V@ 2KΩ | 90V@ 2KΩ | -- | | | | 170V@ 10KΩ | 150V@ 10KΩ | -- | | | Maximum Output<br>Current(+/- 10%) | 180mA@ 500Ω | 60mA@ 500Ω | -- | SE<br>Note 4 | | | 66mA@ 2KΩ | 45mA@ 2KΩ | -- | | | | 17mA@ 10KΩ | 15mA@10KΩ | -- | | | Pulse Duration | 200 µs (Constant) | 220 µs (Constant) | 200 µs (Constant) | SE<br>Note 4 | | Pulse frequency | 1 to 50 Hz | 8.5 to 64 Hz | 50 to 70 Hz | SE<br>Note 4 | | Net Charge (per<br>pulse) | 16.72µC @ 500Ω | 16.0µC @ 500Ω | -- | SE<br>Note 4 | {10}------------------------------------------------ | 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 of<br>Comparison | Subject Device | Predicate Device | Remark | |----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|--------------| | Maximum Phase<br>Charge | 0.12µC@ 500Ω | 13.2μC@ 500Ω | SE<br>Note 4 | | Maximum<br>Average Current | 0.836µA@ 500Ω | 1.024μΑ@ 500Ω | SE<br>Note 4 | | Maximum Current<br>Density<br>(r.m.s ) | $I_{AVR} = C F_{Max}$ Where<br>C= Charge, F=<br>Maximum Frequency<br>$I_{AVR} = 16.72µC x 50Hz =$ $836 µA = 0.836 mA$ | $I_{AVR} = C F_{Max}$ Where<br>C= Charge, F= Maximum<br>Frequency<br>$I_{AVR} = 16.0µC x 64Hz =$ $1024μA = 1.024mA$ | SE<br>Note 4 | | | Max Current Density<br>= IAVR / Square of one<br>electrode<br>= 0.836 mA / 56.7 cm²<br>= 0.015 (mA/cm²) | Max Current Density<br>= IAVR / Square of one<br>electrode<br>= 1.024mA / 32.0cm²<br>= 0.032 (mA/cm²) | | | | 0.015 mA/cm² @ 500Ω<br>(for the smallest size<br>electrode about 56.7<br>cm²) | 0.032 mA/cm² @ 500Ω<br>(for the smallest size<br>electrode 32.0 cm²) | | | Maximum<br>Average Power<br>Density | Max Power Density<br>= $I_{AVR}^2$ R / Square of one<br>electrode<br>= (0.836mA) ² x 500Ω /<br>56.7cm²<br>= 6.16 µW/cm²<0.25<br>(W/cm²) | Max Power Density<br>= $I_{AVR}^2$ R / Square of one<br>electrode<br>= (1.024mA) ² x 500Ω /<br>32.0cm²<br>= 16.4 µW/cm²<0.25<br>(W/cm²) | SE<br>Note 4 | | | 6.16 µW/cm²@ 500Ω | 16.4 µW/cm²@500Ω | | | Burst Mode | | | | | a. Pulse per burst | Mode 1 | 310 - 2500 | SE<br>Note 4 | | | Mode 2 | 10 - 124 | | | | Mode 3 | 61 - 686 | | | | Mode 4 | 81 - 820 | | | | Mode 5 | 81 - 820 | | | | Mode 6 | 127.5 | | | b. Bursts per<br>second | Mode 1 | 2 -16 | SE<br>Note 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 | | {11}------------------------------------------------ | 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 of<br>Comparison | Subject Device | Predicate Device | Remark | | |------------------------------------|------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------|--------------| | | Mode 6 | 39.7 | | | | c. Burst duration<br>(unit: ms) | Mode 1 | 62 - 500 | -- | SE<br>Note 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% | -- | SE<br>Note 4 | | | Mode 2 | 0.27% -<br>0.30% | -- | | | | Mode 3 | 0.30% -<br>0.32% | -- | | | | Mode 4 | 0.25%-<br>0.36% | -- | | | | Mode 5 | 0.25%-<br>0.36% | -- | | | | Mode 6 | 100% | -- | | | ON Time | 1s | 2s | 2.5s | SE<br>Note 4 | | OFF Time | 1s | 2s | 2.5s | SE<br>Note 4 | | Contraction and<br>Relaxation time | Adjusted by FRE-UP<br>and FRE-DOWN<br>buttons, due to different<br>frequencies. | Adjustable, due to<br>different modes. | Adjustable, due to<br>different modes. | SE | | Additional Features | | | | | | Environment for<br>operating | Temperature: 5 ~ 40° C<br>Humidity: ≤80% RH | Temperature: 5 ~ 40° C<br>Humidity: 20 ~ 65% RH | Temperature: 5 ~ 45° C<br>Humidity: 20 ~ 65% RH | SE<br>Note 2 | | Environment for<br>storage | Temperature: 0 ~ 45° C<br>Humidity: ≤93% RH | Temperature: 0 ~ 40° C<br>Humidity: 10 ~ 90% RH | Temperature: 0 ~ 45° C<br>Humidity: 10 ~ 90% RH | SE<br>Note 2 | | Standards | | | | | | Biocompatibility | All user directly<br>contacting materials are<br>compliance with<br>ISO10993-5 and | All user directly contacting<br>materials are compliance<br>with ISO10993-5 and<br>ISO10993-10 | All user directly<br>contacting materials<br>are compliance with<br>ISO10993-5 and | SE | {12}------------------------------------------------ | <b>Sponsor:</b> | Hong Qiang Xing (Shenzhen) Electronics Limited | |------------------------|-----------------------------------------------------------| | <b>Subject Device:</b> | Fitness Belt, Model: SM9065 | | <b>File No.:</b> | 510(k) submission report (V1.0), Chapter 6 510(k) Summary | | Elements of<br>Comparison | Subject Device | Predicate Device | Remark | |---------------------------|------------------------------------------------|-----------------------------------------------|--------| | | ISO10993-10<br>requirements. | ISO10993-10<br>requirements. | | | Electrical Safety | Comply with IEC 60601-<br>1 and IEC 60601-2-10 | Comply with IEC 60601-1<br>and IEC 60601-2-10 | SE | | EMC | Comply with IEC 60601-<br>1-2 | Comply with IEC 60601-<br>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. {13}------------------------------------------------ #### 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.