Muscle Stimulator

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. March 1, 2024 Shenzhen Yiran Intelligent Co., Ltd % Tulin Li Regulatory Manager Huide Medical Technology Service (Shenzhen) Group Co., Ltd. Room 703, Building 16, South Bank Plaza, Exhibition Bay, Zhancheng Community, Fuhai Street, Shenzhen, Guangdong 518053 China Re: K231648 Trade/Device Name: Muscle Stimulator Regulation Number: 21 CFR 882.5890, 21 CFR 890.5850 Regulation Name: Transcutaneous electrical nerve stimulator for pain relief Regulatory Class: Class II Product Code: NUH, NGX Dated: February 26, 2024 Received: February 27, 2024 Dear Tulin Li: 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. {1}------------------------------------------------ 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 mediation-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. Robert Kang -S for Pamela Scott Assistant Director 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 {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K231648 Device Name Muscle Stimulator Indications for Use (Describe) TENS(Transcutaneous Electric Nerve Stimulation): To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities. PMS(Powered Muscle Stimulation): It is intended 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) #### 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 510(k) number: K231648 Date of Summary Preparation: Feb 29, 2024 #### Applicant Name: Shenzhen Yiran Intelligent Co., Ltd Address: Floor 6, No. 531 Nanpu Road, Huangpu Community, Xinqiao Street, Bao'an District, Shenzhen, Guangdong, China Official Correspondent: Huide Medical Technology Service (Shenzhen) Group Co., Ltd. Name: Tulin Li Tel: 0086-186067546446 Mail: yiranintelligent@gmail.com #### Device | Trade Name: | Muscle Stimulator | |---------------------------|------------------------------------------------------| | Common Name: | Stimulator, Nerve, Transcutaneous, Over-The-Counter; | | Power Muscle Stimulator | | | Model Name: | YR-U80-PRO-MAX,YR-U80-PRO, YR-U8-PRO, YR-U8 | | Regulation Classification | 21 CFR 882.5890, 21 CFR 890.5850 | | Product Code: | NUH, NGX | | Classification Panel: | Physical Medicine | | Device Class: | II | #### Predicate Device 510(k) number: K143268 | Trade Name: | TENS AND POWERED MUSCLE STIMULATOR | |---------------------------|-----------------------------------------------------| | Common Name: | Stimulator, Nerve, Transcutaneous, Over-The-Counter | | Power Muscle Stimulator | | | Model Name: | AS-TEC | | Regulation Classification | 21 CFR 882.5890, 21 CFR 890.5850 | | Product Code: | NUH, NGX | | Classification Panel: | Physical Medicine | | Device Class: | II | # Reference Device 510(k) number: K121719 | Trade Name: | SM TENS&PMS | |--------------|------------------------------------------------------------------------------| | Common Name: | Stimulator, Nerve, Transcutaneous, Over-The-Counter; Power Muscle Stimulator | | Model Name: | NA | {4}------------------------------------------------ | Regulation Classification | 21 CFR 882.5890, 21 CFR 890.5850 | |---------------------------|----------------------------------| | Product Code: | NUH, NGX | | Classification Panel: | Physical Medicine | | Device Class: | II | #### Device Description: Muscle Stimulator is a portable and DC 3.7V battery powered multifunction device, offering both Transcutaneous Electrical Nerve Stimulation (TENS) and Powered Muscle Stimulation (PMS) qualities in one device. Muscle Stimulator can give certain electrical pulses through electrode adhesive pads to the suggested area of the body where the electrodes are placed. The electrodes to be used with the device have already been cleared under K182111. The electronic stimulatory module has the operating elements of an On/Off Switch, Intensity buttons, Output channel buttons, T button, Output ports, and USB port for battery charging. The LCD display screen can show time remaining of an application program, battery power, program icons, output channel and intensity, etc. The device is equipped with accessories of electrode pads, electrode cables, a battery charger, and one USB cable. The electrode cables are used to connect the device; the USB cable is used to connect the charger and the built-in lithium battery. All accessories, including USB cables, electrode pads, electrode cables, chargers can only be changed or replaced by a qualified person. #### Indications for use: #### TENS (Transcutaneous Electric Nerve Stimulation): To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities. #### PMS (Powered Muscle Stimulation): It is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance. # Comparison table | | | New Device | Predicate<br>Device | Reference<br>device | Same/Di<br>fferent | |-----|-----------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------| | 1. | 510(k) Number | K231648 | K143268 | K121719 | | | 2. | Marketing<br>clearance<br>date | / | 07/21/2015 | 10/23/2012 | | | 3. | Device Name | Muscle<br>Stimulator | TENS AND<br>POWER<br>ED<br>MUSCLE<br>STIMULATOR | SM TENS & PMS | | | 4. | Model | YR-U80-PRO-<br>MAX,YR-U80-PRO,<br>YR-U8-PRO,YR-U8 | AS-TEC | NA | | | 5. | Manufacturer | Shenzhen Yiran<br>Intelligent Co., Ltd | Shenzhen<br>Technology Co., | Hong Qiangxing<br>(Shen Zhen)<br>Electronics | | | | | | Ltd. | Limited | | | 6. | Intended use | TENS (Program 3, 4):<br>To be used for<br>temporary<br>sore and aching<br>muscles in relief of<br>pain associated with<br>the shoulder, waist,<br>back, upper<br>extremities (arm),and<br>lower extremities<br>(leg) due to strain<br>from exercise or<br>normal household<br>work activities.<br>PMS (Program 1, 2,<br>5,6):<br>It is intended to be<br>used to stimulate<br>healthy muscles in<br>Order to improve<br>and Facilitate<br>muscle<br>performance. | TENS (Mode 1,<br>3, 4, 5,<br>6):<br>To be used for<br>temporary<br>relief of pain<br>associated with<br>sore and aching<br>muscles in<br>the shoulder,<br>waist, back,<br>upper<br>extremities<br>(arm), and<br>lower<br>extremities<br>(leg) due<br>to strain from<br>exercise or<br>normal<br>household work<br>activities.<br>PMS (Mode 1, 2,<br>3, 5):<br>It is intended to<br>be used to<br>stimulate<br>healthy muscles<br>in order to<br>improve and<br>facilitate muscle<br>performance | TENS:<br>To be used for<br>temporary relief<br>of pain<br>associated with<br>sore and aching<br>muscles in the<br>shoulder, waist,<br>back, neck,<br>upper extremities<br>(arm), and lower<br>extremities (leg)<br>due to strain from<br>exercise or<br>normal<br>household work<br>activities.<br>PMS: It is<br>intended to be<br>used to stimulate<br>healthy muscles<br>in order to<br>improve and<br>facilitate muscle<br>performance. | Same Note 1 | | 7. | Type of use | OTC | OTC | OTC | Same | | 7.8 | Power Source(s) | DC 3.7V lithium<br>battery | DC 3.7V lithium<br>battery | DC 3.7V lithium<br>battery | Same | | | - Method of Line<br>Current Isolation | Type BF | Type BF | Type BF | Same | | | - Patient<br>Leakage<br>Current | -- | -- | -- | Same | | | - Normal<br>Condition (μΑ) | 0.1μA | 0.1μA | 2 μA | | | | - Single Fault<br>Condition (μΑ) | 0.1μA | 0.1μA | < 10 μA | | | 9. | Average DC<br>currentthrough<br>electrodes<br>when device is on | < 0.01μA | < 0.01μA | < 0.01μA | Same | {5}------------------------------------------------ {6}------------------------------------------------ {7}------------------------------------------------ | | but no pulses are<br>being applied (μΑ) | | | | | | | | |-----|--------------------------------------------------|---------------------|----------------------------|-------------|-------------------------------|-------------|-------------------------------------|-------------------| | 10. | Number of Output<br>Modes | | 6 | | 6 | | 6 | Same | | 11. | Number of Output<br>channels: | | 2 | | 2 | | 2 | Same | | | - Synchronous<br>or Alternating? | | Synchronous | | Synchronous | | Synchronous | Same | | | - Method of<br>Channel Isolation | | Voltage<br>Isolation | transformer | Voltage<br>Isolation | transformer | Voltage<br>transformer<br>isolation | Same | | 12. | Regulated<br>Currentor<br>Regulated<br>Voltage? | | Voltage control | | Voltage control | | Voltage<br>control | Same | | 13. | Software/Firmware/<br>Microprocessor<br>Control? | | Software | | Software | | Software | Same | | 14. | Automatic<br>Overload<br>Trip? | | No | | No | | No | Same | | 15. | Automatic No-<br>Load<br>Trip? | | Yes | | No | | No | Same<br>Note<br>2 | | 16. | Automatic Shut<br>Off? | | Yes | | Yes | | Yes | Same | | 17. | User Override<br>Control? | | Yes | | Yes | | Yes | Same | | 18. | Indicator<br> | On/Off<br>Status? | Yes | | Yes | | Yes | Same | | | Display | Low<br>Battery<br>? | Yes | | Yes | | Yes | Same | | | | Voltage | Yes | | Yes | | Yes | Same | | | | Current<br>Level? | | | | | | | | 19. | Timer Range<br>(minutes) | | 10 ~ 60 min<br>10 min/step | | 10 ~ 60 minute<br>10 min/step | | 10-60<br>minutes, 10<br>min/step | Same | {8}------------------------------------------------ | 20. | Compliance with<br>Voluntary<br>Standards? | Yes.<br>AAMI/ANSI ES<br>60601-1,<br>IEC 60601-1-2,<br>IEC<br>60601-2-10,<br>IEC 62133,IEC<br>60601-1-11 | Yes.<br>AAMI/ANSI ES60601-<br>1,IEC 60601-1-2, IEC<br>60601-2-10, IEC 62133,<br>IEC<br>60601-1-11 | Yes.<br>AAMI/AN<br>SI<br>ES60601<br>-1,IEC<br>60601-1-<br>2, IEC<br>60601-2-<br>10, IEC<br>62133,IEC<br>60601-1-11 | Same | |-----|-------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------|-----------| | 21. | Compliance with<br>21<br>CFR 8988? | Yes | Yes | Yes | Same | | 22. | Weight (grams) | 262g | 170g | NA | Same | | 23. | Dimensions (mm)<br>[W x H x D] | 110mm*108mm*<br>58mm | 93*50*9mm | NA | Note<br>1 | | 24. | Housing Materials<br>& Construction | ABS | ABS | ABS | | | 25. | Waveform | Pulsed,<br>symmetric,<br>biphasic | Pulsed, symmetric,<br>biphasic | Pulsed,<br>symmetric,<br>biphasic | | | 26. | Shape | Oval, spike | Rectangular, with<br>interphase<br>interval | Rectangular,<br>with<br>interphase<br>interval | | | 27. | Maximum Output<br>Voltage (volts) | 37.2V ±20%<br>@500Ω<br><br>74.2V±20%<br>@2ΚΩ<br><br>138.6V ±20%<br>@10ΚΩ | 53.5V±20% @500Ω<br><br>67V±20% @2kΩ<br><br>68V±20% @10ΚΩ | 42V±10%@5<br>00Ω<br>84V±10%@2k<br>Ω<br>130V±10%@<br>10ΚΩ | | | 28. | Maximum Output<br>Current (specify<br>units) | 74.4mA±20%<br>@500Ω<br><br>37.1mA±20%<br>@2KΩ<br><br>13.86mA±20%<br>@10KΩ | 107mA±20% @500Ω<br><br>33.5mA±20% @2ΚΩ<br><br>6.8±20% @10kΩ | 84mA±10%<br>@500Ω<br><br>42mA±10%<br>@2ΚΩ<br><br>13mA±10%<br>@10KΩ | | | 29. | Pulse width (usec) | Positive phase:<br>200μs±10%<br>Negative<br>phase:<br>200μs±10%<br>Interphase<br>interval:<br>200us±10% | Positive phase: 225µs<br>Negative phase: 225µs<br><br>Interphase interval: 225µs | 100μς | | | 30. | Pulse Period<br>(msec) | 20-1000ms | 8.9~617ms | NA | | | 31. | Pulse frequency | 1-50Hz±10% | 1.62Hz~113Hz | 110Hz | | | | (Hz) [or Rate<br>(pps)] | | | | | | 32. | Net Charge (µC per pulse) | 0µC @500Ω;<br>Method:<br>Balanced<br>waveform | 0µC@500Ω;<br>Method:<br>Balanced waveform | 0µC @500Ω;<br>Method:<br>Balanced<br>waveform | | | 33. | Maximum Phase<br>Charge, (µC) | 15.87µC@500Ω | 48µC @500Ω | 16.8µC@500Ω Note 3 | | | 34. | Maximum Average<br>Current, (mA) | 0.793mA@500Ω | 2.72mA @500Ω | 0.924mA@500Ω | | | 35. | Maximum Current<br>Density, (mA/cm²,<br>r.m.s.) | 0.06mA/cm2<br>area<br>25cm2) | 1.36mA/cm2<br>(Smallest electrode<br>area = 4cm2) | 0.462mA/cm2@500Ω | | | 36. | Maximum Average<br>Power Density,<br>(mW/cm²) | 1.57mW/cm2<br>area<br>25cm2) | 36.4mW/cm2<br>(Smallest electrode<br>area = 4cm2) | 9.702mW/cm2@<br>500Ω | | | 37. | Battery charge | ① The Lithium<br>battery can be<br>recharged<br>throughboth<br>AC adaptor<br>and computer<br>USB input.<br>② When<br>Charging is<br>finished, the<br>LCD will<br>show full cell of<br>battery. | ① The Lithium<br>battery can be<br>recharged through<br>both AC adaptor and<br>computer USB input.<br>② When charging<br>show full cell of<br>battery. | NA | | | 38. | Accessories | Self-adhesive<br>electrodes,<br>electrode<br>wires, Battery<br>charger, USB<br>cable | Self-adhesive<br>electrodes, electrode<br>wires, Battery charger,<br>USB cable | NA | | {9}------------------------------------------------ {10}------------------------------------------------ | Differences between proposed device and predicate device: | |------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | <b>Note 1:</b> | | The proposed device has more treatment programs than the predicate device<br>K143268, but allof the treatment programs have passed the IEC 60601-2-10 test<br>codes. So this difference doesn't raise any safety issues. And the weight,<br>dimensions, housing material, appearance of proposed device are a little<br>different from predicate device K143268. Consider the same intended use,<br>components, working principle, test standards, these differences are<br>insignificant in the terms of safety or effectiveness. | | <b>Note 2:</b> | | The maximum phase charge of the proposed device (15.87µC@500Ω) is less<br>than the predicate device (48µC @500Ω), but the cleared device K121719, which<br>is the predicate device of K143268, has the maximum phase charge of<br>16.8µC@500Ω. The value of the proposed device is similar to that of the 510K<br>clearance device K121719, therefore this difference doesn't raise any new safety<br>and effectiveness issues. | | The maximum average current, maximum current density, maximum average<br>power density have some differences between proposed device and predicate<br>device due to they are calculated by different electrode area. Both of them meet<br>maximum current density <2mA/cm² and maximum average power density<br><0.25W/cm². Therefore these differences don't raise any new safety and<br>effectiveness issues. | | <b>Note 3</b><br>The reference device is being included to demonstrate that the different technological<br>parameters do not have an effect on the safety and effectiveness of the subject<br>device | Muscle Stimulator is safe and effective as the predicate devices cited above. The new devices have passed testing according to the safety standards: # Non-Clinical Testing - 1) ANSI AAMI ES60601-1: 2005/(R)2012 And A1:2012, C1:2009/(R)2012 And A2:2010/(R)2012 (Consolidated Text) Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance (IEC 60601-1:2005, MOD); - 2) IEC 60601-2-10 Edition 2.1 2016-04, Medical Electrical Equipment Part 2-10: Particular Requirements For The Basic Safety And Essential Performance Of Nerve And Muscle Stimulators - 3) ANSI AAMI IEC 60601-1-2:2014, Medical Electrical Equipment -- Part 1-2: General Requirements For Basic Safety And Essential Performance -- Collateral Standard: Electromagnetic Disturbances -- Requirements And Tests; - 4) IEC 62133-2 Edition1.0 2017-02 Secondary Cells And Batteries Containing Alkaline Or Other Non-Acid Electrolytes - Safety Requirements For Portable Sealed Secondary Cells, And For Batteries Made From Them, For Use In Portable Applications - Part 2: Lithium Systems {11}------------------------------------------------ - 5) IEC 60601-1-11 Edition 2.0 2015-01, Medical Electrical Equipment Part 1-11: 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 . (General II (ES/EMC)) ### Clinical Testing No clinical testing was performed on the device. The conclusion drawn from the safety testing is that the new devices are substantially equivalent to the predicate devices. Furthermore, the new devices comply with the recognized standards and perform its intended tasks as well as the legally marketed predicate devices. ## Conclusion In accordance with the Federal Food, Drug and Cosmetic Act 21, CFR Part 807 and based on the Intended Use, Technological Characteristics, Performance data and non-clinical tests performed, the subject device is substantially equivalent and is as safe and as effective as the legally marketed predicate device.