Sunmas TENS & PMS (Model SM9187, SM9180L, SM9180S)

K190009 · Hong Qiangxing (Shenzhen) Electronics Limited · NUH · Dec 2, 2019 · Neurology

Device Facts

• Record ID: K190009
• Device Name: Sunmas TENS & PMS (Model SM9187, SM9180L, SM9180S)
• Applicant: Hong Qiangxing (Shenzhen) Electronics Limited
• Product Code: NUH · Neurology
• Decision Date: Dec 2, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5890
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Model SM9187: TENS (Mode 1, 3, 4, 5, 6): To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities. PMS (Mode 1, 2, 3, 4, 5, 6): It is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance. Model SM9180L & SM9180S: TENS (Mode 1. 3. 4. 5. 6): To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, back due to strain from exercise or normal household work activities. PMS (Mode 1, 2, 3, 4, 5, 6): It is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance.

Device Story

Portable, battery-powered TENS and PMS device; provides electrical stimulation via skin-surface electrodes to relieve pain or condition muscles. Model SM9187 controlled via 'Dr.Stim' mobile app (Bluetooth 4.0); Models SM9180L/SM9180S controlled via dedicated wireless remote. Used in home healthcare environment by patients. Device delivers biphasic/monophasic rectangular pulses; includes multiple modes and adjustable timer. Healthcare providers/patients select modes to manage muscle pain or facilitate performance. Benefits include non-pharmacological pain relief and muscle conditioning.

Clinical Evidence

Bench testing only. No clinical data provided. Safety and effectiveness demonstrated through compliance with voluntary consensus standards including IEC 60601-1, IEC 60601-2-10, IEC 60601-1-2, IEC 60601-1-11, IEC 62133, FCC Part 15, AAMI TIR69, and ANSI C63.27.

Technological Characteristics

Portable battery-powered stimulator; ABS housing. Output: Biphasic/monophasic rectangular pulses; 1-150Hz frequency; 50-250μs pulse width. Connectivity: Bluetooth 4.0 (SM9187) or proprietary RF (SM9180L/S). Power: Rechargeable lithium battery or AAA/coin cell. Standards: IEC 60601-1, IEC 60601-2-10, IEC 60601-1-2, IEC 60601-1-11, IEC 62133, ISO 10993-5/10, AAMI TIR 69, ANSI C63.27.

Indications for Use

Indicated for adults for temporary relief of pain associated with sore/aching muscles in shoulder, waist, back, neck, arms, or legs due to exercise or household strain, and for stimulation of healthy muscles to improve/facilitate muscle performance.

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

• SM TENS & PMS (K121719)
• SmartTENS (K143430)
• ALEVE Direct Therapy TENS Device (K152852)

Submission Summary (Full Text)

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December 2, 2019

Hong Qiangxing (Shen Zhen) Electronics Limited % Doris Dong Manager Shanghai CV Technology Co., Ltd. Room 903, No. 19 Dongbao Road, Songjiang Area Shanghai, 201613 China

Re: K190009

Trade/Device Name: Sunmas TENS & PMS (Model SM9187, SM9180L, SM9180S) Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator For Pain Relief Regulatory Class: Class II Product Code: NUH, NGX Dated: November 27, 2018 Received: January 3, 2019

Dear Doris 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/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.

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

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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 medical devices and radiation-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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

For Vivek Pinto, Ph.D. Acting Division 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

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# Indications for Use

510(k) Number (if known) K190009

Device Name

Sunmas TENS & PMS (Model SM9187, SM9180L, SM9180S)

Indications for Use (Describe) Model SM9187:

TENS (Mode 1, 3, 4, 5, 6):

To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities. PMS (Mode 1, 2, 3, 4, 5, 6):

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

Model SM9180L & SM9180S:

TENS (Mode 1. 3. 4. 5. 6):

To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, back due to strain from exercise or normal household work activities.

PMS (Mode 1, 2, 3, 4, 5, 6):

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)

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# 510(k) Summary

[As required by 21 CFR 807.92]

## 1. Submission Information:

| 510(k) Number: | K190009 |
|------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date: | December 12, 2019 |
| Type of 510(k) Submission: | Traditional |
| Basis for 510(k) Submission: | New device |
| Submitter/Manufacturer: | Hong Qiangxing (Shen Zhen) Electronics Limited<br>4F, Jingcheng Building, Xicheng Industrial Zone, Xixiang Road, Bao'an District,<br>Shenzhen City, Guangdong, China 518126 |
| 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: | Sunmas TENS & PMS (Model SM9187, SM9180L, SM9180S) |
| Common Name: | TENS & PMS |
| Classification Name: | Stimulator, nerve, transcutaneous, over-the-counter,<br>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: | Sunmas TENS & PMS (Model SM9187, SM9180L & SM9180S) is a<br>portable battery powered device with a wireless feature for over-the-counter<br>use, offering both Transcutaneous Electrical Nerve Stimulation (TENS) and<br>Powered Muscle Stimulation (PMS) qualities in one device.<br>Sunmas TENS & PMS has totally 6 modes, applying electrical current<br>to electrodes on a patient's skin to relieve pain or build up muscle.<br>Due to different electrode shapes and sizes, Model SM9187 can be<br>used on the shoulder, waist, back, neck, upper extremities (arm), and lower<br>extremities (legs), while Model SM9180L and SM9180S can be used on the<br>shoulder, back and abdomen.<br>Model SM9187 is designed to be controlled by a mobile phone<br>application program (APP) named “Dr.Stim”, through Bluetooth 4.0<br>technology (Frequency: 2402.0 - 2480.0MHz). The APP is developed by<br>Hong Qiangxing (Shenzhen) electronics Limited. SM9187 consists of a<br>round main unit, two sets of self-adhesive electrode pad, a mobile<br>application (APP), an AC charger and a USB cable.<br>Model SM9180L and SM9180S both have a butterfly-shaped main unit<br>(Frequency: 2450MHz) and can be remotely controlled through wireless<br>technology. SM9180L has a black remote control with an electronic display<br>screen which is powered by two AAA alkaline batteries, while SM9180S |

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has a white remote control powered by a CR2032 coin battery. The radio frequency of remote control (both black and white) is 2405.0 - 2470.0MHz. Model SM9180L and SM9180S consists of a unit, two pairs of electrode gels, a remote control (black or white), an AC charger and a USB cable. Model SM9187:

Indications for use:

## TENS (Mode 1, 3, 4, 5, 6):

To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities.

## PMS (Mode 1, 2, 3, 4, 5, 6):

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

## Model SM9180L & SM9180S:

## TENS (Mode 1, 3, 4, 5, 6):

To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, back due to strain from exercise or normal household work activities.

## PMS (Mode 1, 2, 3, 4, 5, 6):

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:

Table 1 -

| | Parameters | New Device | Predicate Device 1 | Predicate Device 2 | |
|-----|--------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------|
| 1. | 510(k) Number: | K190009 | K121719 | K143430 | |
| 2. | Marketing clearance date: | May 10, 2013 | May 10, 2013 | May 29, 2015 | |
| 3. | Device Name | SM9187 | SM TENS & PMS | SmartTENS | |
| 4. | Manufacturer | Hong Qiangxing (Shenzhen) Electronics Limited | Hong Qiangxing (Shenzhen) Electronics<br>Limited | EasyMed Instruments Co., Ltd. | |
| 5. | Product code | NUH, NGX | NGX, NUH | NUH | |
| 6. | Accessories | Self-adhesive electrodes, Battery charger, USB cable | Self-adhesive electrodes, electrode wires, Battery<br>charger, USB cable | Button-affixed electrode, Replaceable Hydrogel<br>Pads( (gel-pads) )73mm x 62mm, charger cradle,<br>charging adapter | |
| 7. | Intended use | TENS (Mode 1, 3, 4, 5, 6):<br>To be used for temporary relief of pain associated<br>with sore and aching muscles in the shoulder,<br>waist, back, neck, upper extremities (arm), and<br>lower extremities (leg) due to strain from exercise<br>or normal household work activities.<br>PMS (Mode 1, 2, 3, 4, 5, 6):<br>It is intended to be used to stimulate healthy<br>muscles in order to improve and facilitate muscle<br>performance. | TENS (Mode 1, 3, 4, 5, 6):<br>To be used for temporary relief of pain associated<br>with sore and aching muscles in the shoulder,<br>waist, back, neck, upper extremities (arm), and<br>lower extremities (leg) due to strain from exercise<br>or normal household work activities.<br>PMS (Mode 1, 2, 3, 6):<br>It is intended to be used to stimulate healthy<br>muscles in order to improve and facilitate muscle<br>performance. | This device is intended for the relief of pain<br>associated with sore or aching muscles of the<br>lower back, arms, or legs due to strain from<br>exercise or normal household and work activities. | |
| 8. | Target Population | Adult | Adult | Adult | |
| 9. | Type of use | OTC | OTC | OTC | |
| 10. | Wireless Control | Yes(Bluetooth device controlled by Application) | No | Yes(Bluetooth device controlled by Application) | |
| 11. | Number of Output Modes | 6 | 6 | 7 | |
| | | | | | |
| 12. | Number of Output channels: | | 1 | 2 | 1 |
| | - Synchronous or | | NA | Synchronous | NA |
| | Alternating? | | | | |
| | - Method of Channel | | NA | Voltage transformer Isolation | NA |
| | Isolation | | | | |
| 13. | Waveform (e.g. pulsed | | Biphasic rectangular | Biphasic rectangular | Biphasic rectangular |
| | monophasic, biphasic) | | Monophasic rectangular | Monophasic rectangular | Monophasic rectangular |
| 14. | Power Source(s) | | 3.7V rechargeable lithium battery | 3.7V rechargeable lithium battery | 3.7V rechargeable lithium battery |
| | - Method of Line Current | | Type BF | Type BF | Type BF |
| | Isolation | | | | |
| | - Patient Leakage Current | | -- | -- | -- |
| | | - Normal Condition (μΑ) | < 10μΑ | < 10μΑ | Not publicly available |
| | Single Fault Condition (μΑ) | | < 50μΑ | < 50μA | Not publicly available |
| | | | | | |
| 15. | Average DC current through electrodes when | | <0.01μA | <0.01μA | Not publicly available |
| | device is on but | | | | |
| | no pulses are being applied (µA) | | | | |
| 16. | Regulated Current or Regulated | | Voltage control | Voltage control | Not publicly available |
| | Voltage? | | | | |
| 17. | Software/Firmware/Microprocessor Control? | | Yes | Yes | Yes |
| | | | | | |
| 18. | Automatic Overload Trip? | | No | No | Yes |
| 19. | Automatic No-Load Trip? | | No | No | Yes |
| 20. | Automatic Shut Off? | | Yes | Yes | Yes |
| 21. | User Override Control? | | Yes | Yes | Yes |
| 22. | Indicator | On/Off Status? | Yes | Yes | Yes |
| | Display: | Low Battery? | No | Yes | Yes |
| | | Voltage/Current | Yes | Yes | Yes…