TENS and Muscle Stimulator

K200727 · Shenzhen Astec Technology Co., Ltd. · NUH · Jun 18, 2020 · Neurology

Device Facts

• Record ID: K200727
• Device Name: TENS and Muscle Stimulator
• Applicant: Shenzhen Astec Technology Co., Ltd.
• Product Code: NUH · Neurology
• Decision Date: Jun 18, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5890
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

Portable, battery-powered (3.7V DC) TENS and PMS device; delivers electrical pulses via adhesive electrode pads to body areas. Features LCD screen, intensity/channel controls, and multiple operation programs (20 for AS8012; 24 for AS8015). Operated by user in home environment. Device transforms electrical energy into biphasic, symmetric, rectangular pulses; output parameters (voltage, frequency, pulse width) controlled by internal microprocessor. Output affects nerve/muscle tissue to provide pain relief or muscle conditioning. Safety features include automatic shut-off and no-load trip. Healthcare providers or users monitor status via LCD (time, battery, intensity). Benefits include non-pharmacological pain management and muscle performance enhancement.

Clinical Evidence

Bench testing only. No clinical data provided. Compliance demonstrated with AAMI/ANSI ES60601-1, IEC 60601-2-10, IEC 60601-1-2, IEC 62133, and IEC 60601-1-11. Electrical output parameters verified against safety limits for current density (<2mA/cm²) and power density (<0.25W/cm²).

Technological Characteristics

Portable, DC 3.7V lithium battery-powered stimulator. Materials: ABS and stainless iron. Waveform: Pulsed, symmetric, biphasic. Output: 2 channels, voltage-controlled. Connectivity: USB for charging. Standards: AAMI/ANSI ES 60601-1, IEC 60601-1-2, IEC 60601-2-10, IEC 62133, IEC 60601-1-11. Software: Microprocessor-controlled with multiple pre-set programs.

Indications for Use

Indicated for temporary relief of pain in shoulder, waist, back, upper, and lower extremities due to exercise or household strain; also indicated for stimulation of healthy muscles to improve/facilitate muscle performance. For OTC use.

Regulatory Classification

Identification

A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain.

Predicate Devices

• TENS AND POWERED MUSCLE STIMULATOR (K143268)
• MHD TENS (K190115)

Reference Devices

• K121719

Submission Summary (Full Text)

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June 18, 2020

Shenzhen As Tec Technology Co., Ltd % Doris Dong Manager Shanghai CV Technology Co., Ltd Room 903, No. 19 Dongbao Road, Songjiang Area Shanghai, China 201613

Re: K200727

Trade/Device Name: TENS and Muscle Stimulator Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator For Pain Relief Regulatory Class: Class II Product Code: NUH, NGX Dated: March 10, 2020 Received: March 20, 2020

Dear Ms. Dong:

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/cfpmr/pmn.cfm identifies combination product submissions. The general controls provisions of the Actinclude 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

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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-devices/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device (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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

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 Quality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K200727

Device Name

TENS and Muscle Stimulator (Model AS8012 & AS8015)

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)

| <span></span> Prescription Use (Part 21 CFR 801 Subpart D) |
|------------------------------------------------------------|
| <span></span> Over-The-Counter Use (21 CFR 801 Subpart C) |

_ | Prescription Use (Part 21 CFR 801 Subpart D)

X Over-The-Counter Use (21 CFR 801 Subpart C)

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# 510(k) Summary

[As required by 21 CFR 807.92]

# 1. Submission Information:

| 510(k) Number: | K200727 |
|------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date: | December 27, 2019 |
| Type of 510(k) Submission: | Traditional |
| Basis for 510(k) Submission: | New device |
| Submitter/Manufacturer: | Shenzhen As-Tec Technology Co., Ltd. |
| | 8E XinBaoYi Industrial Bld, Houting Village Beiting Road, Shajing<br>Shenzhen Guangdong, CHINA 518012 |
| Contact: | Doris Dong<br>[Consultant, from Shanghai CV Technology Co., Ltd.]<br>Add: Room 903, No. 19 Dongbao Road, Songjiang Area, Shanghai, 201613 China<br>E-mail: [e-mail]<br>Tel: [phone] / Fax: [phone] |

| 2. Device Description: | |
|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Proprietary Name: | TENS and Muscle Stimulator (Model AS8012, AS8015) |
| Common Name: | TENS & PMS |
| Classification Name: | Stimulator, nerve, transcutaneous, over-the-counter, Stimulator, muscle, powered, for muscle conditioning |
| Regulation Number: | 882.5890, 890.5850 |
| Product Code: | NUH, NGX |
| Device Class: | II |
| Review Panel: | Neurology & Physical Medicine |
| Device Description: | TENS and 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.<br>TENS and Muscle Stimulator can give certain electrical pulses through electrode adhesive pads to the suggested area of the body where the electrodes are placed. AS8012 has 20 operation programs and AS8015 has 24 operation programs.<br>The electronic stimulatory module has the operating elements of an On/Off Switch, LCD display screen, Intensity buttons, Output channel buttons, T button, Output ports, and USB port for battery charging,etc.<br>The LCD display screen can show time remaining of an application program, battery power, program icons, output channel and intensity,etc.<br>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 pads to the device; the USB cable is used to connect the charge and the built-in lithium battery. All accessories, including USB cables, |

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| | electrode pads, electrode cables, chargers can only be changed or replaced<br>by a qualified person. |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for use: | <b>TENS</b> ( <i>Transcutaneous Electric Nerve Stimulation</i> ):<br>To be used for temporary relief of pain associated with sore and aching<br>muscles in the shoulder, waist, back, upper extremities (arm), and lower<br>extremities (leg) due to strain from exercise or normal household work<br>activities. |
| | <b>PMS</b> ( <i>Powered Muscle Stimulation</i> ): |

It is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance.

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# 3. Substantial Equivalence to Predicate device:

Detailed comparison data is included in "Section 10.1 - Substantial Equivalence Discussion" of this 510(k) submission.

Table 1 -

| Parameters | New Device | Predicate Device | Same/Different | | |
|---------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------|----------------|
| 1. | 510(k) Number | Unassigned | K143268 | | |
| 2. | Marketing clearance<br>date | / | 07/21/2015 | | |
| 3. | Device Name | TENS and Muscle<br>Stimulator | TENS AND POWERED<br>MUSCLE STIMULATOR | | |
| 4. | Model | AS8012 | N/A | | |
| 5. | Manufacturer | Shenzhen As-Tec<br>Technology Co., Ltd. | Shenzhen As-Tec<br>Technology Co., Ltd. | SE | |
| 6. | Intended use | TENS (Program 3, 4, 8,<br>9,12, 13, 14, 15, 17, 18, 19,<br>20):<br>To be used for temporary<br>relief of pain associated with<br>sore and aching muscles in<br>the shoulder, waist, back,<br>upper extremities (arm), and<br>lower extremities (leg) due<br>to strain from exercise or<br>normal household work<br>activities.<br>PMS (Program 1, 2, 5, 6, 7,<br>10, 11, 16):<br>It is intended to be used to<br>stimulate healthy muscles in<br>order to improve and<br>facilitate muscle<br>performance. | TENS (Mode 1, 3, 4, 5, 6):<br>To be used for temporary<br>relief of pain associated with<br>sore and aching muscles in<br>the shoulder, waist, back,<br>upper extremities (arm), and<br>lower extremities (leg) due<br>to strain from exercise or<br>normal household work<br>activities.<br>PMS (Mode 1, 2, 3, 5):<br>It is intended to be used to<br>stimulate healthy muscles in<br>order to improve and<br>facilitate muscle<br>performance. | Same<br>Note 1 | |
| 7. | Type of use | OTC | OTC | Same | |
| 7.8 | Power Source(s) | DC 3.7V lithium battery | DC 3.7V lithium battery | Same | |
| | - Method of Line<br>Current Isolation | Type BF | Type BF | Same | |
| | - Patient Leakage<br>Current | -- | -- | Same | |
| | - Normal<br>Condition (μΑ) | 0.1μΑ | 0.1μΑ | | |
| | - Single Fault<br>Condition (μΑ) | 0.1μΑ | 0.1μΑ | | |
| 9. | Average DC current<br>through electrodes<br>when device is on | < 0.01μΑ | < 0.01μΑ | Same | |
| 8E XinBao Y1 Industrial Bld, Houting Village Beiting Road, Shajing Shenzhen Guangdong, CHINA 518012<br>but no pulses are being applied (µA) | | | | | |
| 10. | Number of Output Modes | | 20 | 6 | Same<br>Note 1 |
| 11. | Number of Output channels: | | 2 | 2 | Same |
| | | - Synchronous or Alternating? | Alternating | Synchronous | Same<br>Note 2 |
| | | - Method of Channel Isolation | Voltage transformer<br>Isolation | Voltage transformer<br>Isolation | Same |
| 12. | Regulated Current or Regulated Voltage? | | Voltage control | Voltage control | Same |
| 13. | Software/Firmware/Microprocessor Control? | | Software | Software | Same |
| 14. | Automatic Overload Trip? | | No | No | Same |
| 15. | Automatic No-Load Trip? | | Yes | No | Same<br>Note 2 |
| 16. | Automatic Shut Off? | | Yes | Yes | Same |
| 17. | User Override Control? | | Yes | Yes | Same |
| 18. | Indicator Display | On/Off Status? | Yes | Yes | Same |
| | | Low Battery? | Yes | Yes | Same |
| | | Voltage/ Current Level? | Yes | Yes | Same |
| 19. | Timer Range (minutes) | | 10 ~ 60 minutes, 10 min/step | 10 ~ 60 minutes, 10 min/step | Same |
| 20. | Compliance with Voluntary Standards? | | Yes.<br>AAMI/ANSI ES 60601-1, IEC 60601-1-2, IEC 60601-2-10, IEC 62133, IEC 60601-1-11 | Yes.<br>AAMI/ANSI ES60601-1, IEC 60601-1-2, IEC 60601-2-10, IEC 62133, IEC 60601-1-11 | Same |
| 21. | Compliance with 21 CFR 8988? | | Yes | Yes | Same |
| 22. | Weight (grams) | | 72g | 170g | Same |
| 23. | Dimensions (mm) [W x H x D] | | 55.4*103*12mm | 93*50*9mm | Same<br>Note 1 |
| 24. | Housing Materials & Construction | | ABS+Stainless iron | ABS | Same |
| 25. | Waveform | Pulsed, symmetric, biphasic | Pulsed, symmetric, biphasic | Same | |
| 26. | Shape | Rectangular, with interphase interval | Rectangular, with interphase interval | Same | |
| 27. | Maximum Output<br>Voltage (volts) | $49.6V±20% @500Ω$<br>$90V±20% @2kΩ$<br>$120V±20% @10kΩ$ | $53.5V±20% @500Ω$<br>$67V±20% @2kΩ$<br>$68V±20% @10kΩ$ | Same<br>Note 3 | |
| 28. | Maximum Output<br>Current (specify<br>units) | $99.2mA±20% @500Ω$<br>$45mA±20% @2kΩ$<br>$12mA±20% @10kΩ$ | $107mA±20% @500Ω$<br>$33.5mA±20% @2kΩ$<br>$6.8±20% @10kΩ$ | | |
| 29. | Pulse width (µsec) | Positive phase: 80µs±10%<br>Negative phase: 80µs±10%<br>Interphase interval: 80µs±10% | Positive phase: 225µs<br>Negative phase: 225µs<br>Interphase interval: 225µs | | |
| 30. | Pulse Period (msec) | 10-1000ms | 8.9~617ms | | |
| 31. | Pulse frequency<br>(Hz) [or Rate (pps)] | 1-100Hz±10% | 1.62Hz~113Hz | | |
| 32. | Net Charge (µC per<br>pulse) | $0μC @500Ω$ ; Method:<br>Balanced waveform | $0μC @500Ω$ ; Method:<br>Balanced waveform | Same | |
| 33. | Maximum Phase<br>Charge, (µC) | $15.87μC@500Ω$ | $48μC @500Ω$ | Same<br>Note 4 | |
| 34. | Maximum Average<br>Current, (mA) | $0.793mA@500Ω$ | $2.72mA @500Ω$ | | |
| 35. | Maximum Current<br>Density, (mA/cm²,<br>r.m.s.) | 0.06mA/cm² @500Ω<br>(Smallest electrode area 25cm²) | 1.36mA/cm² (Smallest electrode area 4cm²) | | |
| 36. | Maximum Average<br>Power Density,<br>(mW/cm²) | 1.57mW/cm² @500Ω<br>(Smallest electrode area 25cm²) | 36.4mW/cm² (Smallest electrode area 4cm²)…