EM25 - glute toning device

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle with three heads, all facing to the right. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 July 27, 2015 Hivox Biotek, Inc. Clytie Chiou Product Manager 5 F., NO. 123, Shingde Road, San-Chong District New Taipei City 24158, Taiwan Re: K143737 Trade/Device Name: EM25-glute toning device Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: NGX Dated: June 24, 2015 Received: June 26, 2015 Dear Clytie Chiou, We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in {1}------------------------------------------------ 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" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours, # Carlos L. Pena -5D/Δ Carlos L. Peña, PhD, MS 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) K143737 Device Name EM25 - glute toning device Indications for Use (Describe) The EM25 - glute toning device is intended for use by healthy persons to apply transcutaneous electrical muscle stimulation (EMS) through skin contact electrodes for the purpose of improvement of muscle tone of the buttocks muscles. | Type of Use (Select one or both, as applicable) | <table><tr><td><input type="checkbox"/> Prescription Use (Part 801 Subpart D)</td></tr><tr><td><input checked="" type="checkbox"/> Over-The-Counter Use (801 CFR 801 Subpart C)</td></tr></table> | <input type="checkbox"/> Prescription Use (Part 801 Subpart D) | <input checked="" type="checkbox"/> Over-The-Counter Use (801 CFR 801 Subpart C) | |----------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------|----------------------------------------------------------------------------------| | <input type="checkbox"/> Prescription Use (Part 801 Subpart D) | | | | | <input checked="" type="checkbox"/> Over-The-Counter Use (801 CFR 801 Subpart C) | | | | _ | Prescription Use (Part 21 CFR 801 Subpart D) |X Over-The-Counter Use (21 CFR 801 Subpart C) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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}------------------------------------------------ #### 510(k) Summary | 5.1 | Type of Submission: | Traditional | |-----|----------------------|----------------------------------------------------------------------------------------------| | 5.2 | Preparation Date: | July 22, 2015 | | 5.3 | Submitter: | Hivox Biotek, Inc. | | | Address: | 5F., No. 123, Shingde Road, San-Chong<br>District, New Taipei City 24158, Taiwan<br>(R.O.C.) | | | Phone: | +886-2-8511-2668 | | | Fax: | +886-2-8511-2669 | | | Contact: | Clytie Chiou<br>(clytie.chiou@hivox-biotek.com) | | | Registration number: | 9611558 | #### 5.4 Identification of the Device: | Proprietary/<br>Trade name: | EM25 - glute toning device | |-----------------------------|---------------------------------------------------------| | Classification Name: | Stimulator, Muscle, Powered, For Muscle<br>Conditioning | | Device Classification: | II | | Regulation Number: | 890.5850 | | Panel: | Physical Medicine | | Product Code: | NGX | #### 5.5 Identification of the Predicate Device: | Predicate Device Name: | Buttock Muscle Stimulator, model:<br>WL-2413E | |------------------------|-----------------------------------------------| | Manufacturer: | Well-Life Healthcare Limited. | | Regulation number: | 890.5850 | | Product Code: | NGX | | 510(k) Number: | K123075 | {4}------------------------------------------------ #### 5.6 Intended Use and Indications for Use of the subject device. The EM25 - glute toning device is intended for use by healthy persons to apply transcutaneous electrical muscle stimulation (EMS) through skin contact electrodes for the purpose of improvement of muscle tone of the buttocks muscles. #### 5.7 Device Description The proposed device, EM25 - glute toning device is a self-adhesive EMS device for muscle training. The device can be applied with accuracy thanks to the use of EMS technology. Made from medical-quality silicone rubber, the elegantly designed EMS pad is extremely slim and flexible and adapts perfectly to the area to be treated. The high-tech circuit provides energy-efficient treatments of 20 minutes each. Electrical muscle stimulation (EMS) is a widespread and generally recognized method and has been used in sports medicine and rehabilitation for years. In sports and fitness, EMS is used to complement conventional muscle training, to increase the performance of muscle groups and to adjust physical proportions to achieve the desired aesthetic results. EMS devices work by passing electrical currents over the skin. The gel pad is used as a transfer medium and is subject to natural wear and tear. The gel pad must be replaced if it stops providing sufficient contact, as this will prevent the EMS pad from sticking to the skin. If it is not replaced, the partially increased current density could irritate the skin. The proposed device, EM25 - glute toning device is assembled with the PCBA and electrode, and the LR03 (AAA) battery supplies the safe low-frequency current. The electrode stuck on the human skin purposes to train the deep muscle. There are 0-15 intensity levels for EM25 - glute toning device. The maximum voltage is divided by 15 (levels) and accumulated for each voltage. But the each increased amperage cannot be over 2%. The intensity level will be minimum when turning on. The user can adjust it from 0 to 15 and gradually increase the intensity level. The whole treatment time is 20 minutes, and then the device switches off automatically. {5}------------------------------------------------ EM25 - glute toning device Hivox Biotek, Inc. 510(k) Notification, K143737 # 5.8 Non-clinical Testing A series of safety tests were performed to assess the safety and effectiveness of the EM25 - glute toning device. | Testing Item | Standard and regulations applied | |---------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Biocompatibility | ISO 10993-1 Biological evaluation of medical devices – Part 1:<br>Evaluation and testing with a risk management process. | | | EN ISO 10993-2:2006, Biological evaluation of medical devices –<br>Part 2: Animal welfare requirements. | | | EN ISO 10993-5:2009, Biological evaluation of medical devices -<br>Part 5: Tests for In Vitro Cytotoxicity. | | | EN ISO 10993-10:2010, Biological evaluation of medical devices -<br>Part 10: Tests for irritation and skin sensitization. | | | EN ISO 10993-12:2009, Biological evaluation of medical devices -<br>Part 12: Sample preparation and reference materials. | | Software | IEC 62304: 2006 Medical device software - Software life cycle<br>processes. | | | ISO 14971:2007 Medical devices - Application of risk management<br>to medical devices. | | Electromagnetic<br>Compatibility &<br>Electrical Safety | IEC 60601-1, Medical Electrical Equipment - Part 1: General<br>Requirements For Basic Safety And Essential Performance | | | IEC 60601-1-11, Medical Electrical Equipment - Part 1-11: General<br>Requirements For Basic Safety And Essential Performance -<br>Collateral Standard: Requirements For Medical Electrical<br>Equipment And Medical Electrical Systems Used In The Home<br>Healthcare Environment. | | | IEC 60601-2-10, Medical Electrical Equipment - Part 2-10:<br>Particular Requirements For The Basic Safety And Essential<br>Performance Of Nerve And Muscle Stimulators. | | Risk Management | ISO 14971:2007 Medical devices - Application of risk management<br>to medical devices | {6}------------------------------------------------ All the test results demonstrate that EM25 - glute toning device meet the requirements of its pre-defined acceptance criteria and intended uses. # 5.9 Clinical Testing No clinical test data was used to support the decision of safety and effectiveness. ### 5.10 Substantial Equivalence Determination The EM25 - glute toning device is substantially equivalent in intended use, design, technology/principles of operation and performance to the cleared Buttock Muscle Stimulator, model: WL-2413E (K123075). Differences between the devices cited in this section do not raise any new issues of safety or effectiveness. | | Proposed Device | Predicate Device | |---------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Item | EM25 - glute toning device | Buttock Muscle Stimulator | | Model | EM25 | WL-2413E | | Manufacturer | Hivox Biotek, Inc. | Well-Life Healthcare Limited. | | Intended Use | The EM25 - glute toning device<br>is intended for use by healthy<br>persons to apply transcutaneous<br>electrical muscle stimulation<br>(EMS) through skin contact<br>electrodes for the purpose of<br>improvement of muscle tone of<br>the buttocks muscles. | The Bullock Muscle Stimulator,<br>model WL-2413E, is intended<br>for use by healthy persons to<br>apply transcutaneous electrical<br>muscle stimulation (EMS)<br>through skin contact electrode<br>for the purpose of improvement<br>of muscle tone of the buttocks<br>muscles. | | Prescription or OTC | OTC | OTC | | Regulation Number | 890.5850 | 890.5850 | | Product Code | NGX | NGX | | Electrode Used | K131720, HIVOX self-adhesive<br>electrode gel pads | K082065, SiliconPad Electrode<br>(7.0cm diameter) | | Comparison of Significant device features: | | | | |-------------------------------------------------------------------------------------------------------|--------------------------------------------|----------------------------------|-------------| | | | | | | | Proposed Device | Predicate Device | | | 510(k) Number | K143737 | K123075 | | | Item | EM25 - glute toning device | Buttock Muscle Stimulator | | | Model | EM25 | WL-2413E | | | Manufacturer | Hivox Biotek, Inc. | Well-Life Healthcare<br>Limited. | | | Power Sources | 1.5V x2 (AAA side)<br>(Alkaline type ONLY) | 1.5V x3 (AAA Size) | | | -Method of Line current<br>Isolation | Type BF | Type BF | | | -Patient Leakage Current | — | — | | | Average DC current through<br>electrodes when device is on<br>but no pulses are being<br>applied (µA) | N/A | N/A | | | Number of Output Modes | 1 | 4 | | | Number of output<br>Channels: | Synchronous<br>or Alternating? | Not applicable (one<br>channel) | Synchronous | | | Method of<br>Channel<br>Isolation? | Not applicable (one<br>channel) | Output Coil | | Regulated Current or<br>Regulated Voltage? | Voltage | Voltage | | | Software/Firmware/<br>Microprocessor control? | Yes | Yes | | | Automatic Overload Trip? | No | No | | | Automatic No-Load Trip? | No | Yes | | | Automatic Shut Off? | Yes | Yes | | | User Override control? | Yes | No | | | Indicator On/Off Status? | No. alerted by sound | Yes | | {7}------------------------------------------------ EM25 - glute toning device Comparison of Basic Unit Characteristics: {8}------------------------------------------------ # EM25 - glute toning device | Display: | Low Battery? | No, alerted by sound | Yes | |--------------------------------------|-------------------------|----------------------|---------------| | | Voltage /Current Level? | No, alerted by sound | Yes | | Timer Range (Minutes) | | 20 | 20-40 | | Compliance with Voluntary Standards? | | IEC60601-2-10 | IEC60601-2-10 | | Compliance with 21 CFR 898? | | YES | Yes | | Weight (g) including battery | | 133 | 80 | | Dimensions [W x H x D] (mm) | | 429 X 125 X 21 | 64 X 90 X 20 | | Housing Materials and construction | | Silicone & ABS | ABS | Comparison of Output Specifications: | | Proposed Device | Predicate Device | |-------------------------------------------------|-----------------------------------------------|------------------------------------------------| | Item | EM25 - glute toning device | Buttock Muscle Stimulator | | Model | EM25 | WL-2413E | | Waveform (e.g., pulsed<br>monophasic, biphasic) | Symmetrical Biphasic | Biphasic | | Shape | Butterfly shaped | Retangular | | Maximum Output Voltage<br>(volts) - (+/- 20%) | 64.8V @ 500Ω<br>120V @ 2kΩ<br>132V @ 10kΩ | 40.8V @ 500Ω<br>70.0V @ 2kΩ<br>106.0V @ 10kΩ | | Maximum Output Current<br>(mA) - (+/-20%) | 129.6mA @ 500Ω<br>60mA @ 2kΩ<br>13.2mA @ 10kΩ | 81.6mA @ 500Ω<br>35.0mA @ 2kΩ<br>10.6mA @ 10kΩ | | Duration of primary phase<br>(µsec) | 400 fixed | 300 Max | | Pulse Duration (usec) | 400 fixed | 720 Max | | Pulse length | 400 μs | unknown | {9}------------------------------------------------ | Pulse Frequency (Hz) | 4-50 | 70 Max | | |----------------------------------------------------------|----------------------------------------|----------------------------------------|-----------| | Atmospheric pressure operation | 700-1060 hPa | unknown | | | For multiphasic waveforms only: | Symmetrical phases? | Yes | Yes | | | Phase Duration | N/A | N/A | | Net charge (µC) | 0 | 0 | | | Method of achieving zero net charge for net charge/pulse | Biphasic symmetric wave for each pulse | Biphasic symmetric wave for each pulse | | | Max. phase charge | 50 µC | 24 µC | | | Max. current Density | 1.1549mA/cm²/500Ω | 0.0997 mA/ cm² | | | Max. Power Density | 0.0748Watts/cm²/500Ω | 0.00399 Watts/ cm² | | | Max. Average current(RMSA) | 500Ω | 129.6mA | 38.644mA | | | 2ΚΩ | 60mA | 16.907 mA | | | 10Ω | 13.2mA | 5.120 mA | | Burst Mode | YES | Yes | | | Pulse per burst | 50 | Same for each program | | | Burst per second | 18 | Same for each program | | | Burst duration | 400µs | Same for each program | | | Duty Cycle | 7200 | Same for each program | | #### 5.11 Summary for the comparison The EM25 - glute toning device is substantially equivalent in intended use, design, technology/principles of operation and performance to the predicate device, Buttock Muscle Stimulator, model: WL-2413E (K123075). The proposed device has tested on safety and performance tests and the results were complied with the test requests. Although there are some differences in the output parameters between proposed device and predicate device, the differences did not raise any problems of safety or effectiveness. {10}------------------------------------------------ ### 5.12 Conclusion After analyzing bench tests, safety testing data, it can be concluded that the EM25 glute toning device is substantially equivalent to the predicate device.