SM TENS & PMS

K121719 · Hong Qiangxing (Shenzhen) Electronics Limited · NGX · May 10, 2013 · Physical Medicine

Device Facts

• Record ID: K121719
• Device Name: SM TENS & PMS
• Applicant: Hong Qiangxing (Shenzhen) Electronics Limited
• Product Code: NGX · Physical Medicine
• Decision Date: May 10, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5850
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

SM TENS & PMS is a portable, battery-powered device providing transcutaneous electrical nerve stimulation (TENS) and powered muscle stimulation (PMS). Device uses electrode adhesive pads placed on body areas to deliver electrical pulses. User interface includes ON/OFF switch, display screen, mode selection, intensity adjustment, and timer. Device features 6 operation modes and 2 output channels. Powered by DC 3.7V lithium battery, rechargeable via USB. Intended for over-the-counter use to relieve muscle pain or improve muscle performance. Output parameters (voltage, current, frequency) are controlled by internal software. Healthcare providers or patients use the device to manage muscle soreness or facilitate conditioning. Benefits include non-invasive pain relief and muscle stimulation.

Clinical Evidence

Bench testing only. Device performance verified through compliance with IEC 60601-1 (General Safety), IEC 60601-2-10 (Nerve/Muscle Stimulator Safety), IEC 60601-1-2 (EMC), IEC 62133 (Battery Safety), and FCC Part 18 (Conducted Emissions). No clinical data provided.

Technological Characteristics

Portable, DC 3.7V lithium battery-powered stimulator. Delivers pulsed, symmetric, biphasic rectangular waveforms. 2 output channels with voltage transformer isolation. Type BF applied part. Connectivity via USB for charging. Software-controlled operation with 6 modes and adjustable timer (10-60 min). Complies with IEC 60601-1, IEC 60601-2-10, IEC 60601-1-2, IEC 62133, and FCC Part 18.

Indications for Use

Indicated for temporary relief of pain in muscles of shoulder, waist, back, neck, arms, and legs due to exercise or household strain (TENS); and stimulation of healthy muscles to improve/facilitate muscle performance (PMS).

Regulatory Classification

Identification

A powered muscle stimulator is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area.

Predicate Devices

• Powered Muscle Stimulator, JQ-5C (K102598)

Submission Summary (Full Text)

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l long Qiangxing (Shen Zhen) Electronics Limited 4F. Jingcheng Building. Xicheng Industrial Zone. Xixiang Road. Bao an District. Shenzhen. Guangdong. China

Tcl: 86-755 26423605 / Url: www.sunmas.hk

### Section 5 510(k) Summary [As required by 21 CFR 807.92]

1. Submission Information:

Type of 510(k) Submission:

Basis for 510(k) Submission:

Submitter/Manufacturer:

510(k) Number:

Date:

Contactor:

·K121719 October 23td, 2012 Traditional New device Hong Qiangxing (Shen Zhen) Electronics Limited 4F, Jingcheng Building, Xicheng Industrial Zone, Xixiang Road, Bao'an District, Shenzhen City, Guangdong, China 518126 Doris Dong [Consultant, from Shanghai CV Technology Co., Ltd.] Add .: Room 1706 Yuesha, No. 128 Songle Rd., Songjiang, Shanghai, China 201600 E-mail: [e-mail] Tel: [phone] Fax: [phone]

2. Device Description: Proprietary Name: Common Name: . Classification Name:

Regulation Number: Product Code: Device Class: Review Panel: Device Description:

TENS & PMS Stimulator, nerve, transcutaneous, over-the-counter, Stimulator, muscle, powered, for muscle conditioning 882.5890. 890.5850 NUH, NGX II

Neurology & Physical Medicine

SM TENS & PMS

SM TENS & PMS is a portable and DC 3.7V battery powered multi function device, offering both Transcutancous Electrical Nerve Stimulator (TENS) and Powered Muscle Stimulator (PMS) qualities in one device. '

SM TENS & PMS has 6 operation modes, which can give certain electrical pulses through electrode adhesive pads to the suggested area of the body where the electrodes are placed.

The electronic stimulatory module has the operating elements of ON/OFF Switch, Display screen, Mode Selection key, Intensity Modification keys, Timing key, Pause key, Output socket, and USB port for battery charging

The display screen can show battery power, selected mode, current intensity, time remaining of an application mode, and indication of a pause.

The device is equipped with accessories of electrode pads, electrode cables, battery chargers, and USB cables. The electrode cables are used to connect the pads to 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 by special

# MAY 1 0 2013

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Hong Qiangxing (Shen Zhen) Electronics Limited

Hong Qiangxing (Shen Zhen) Electronics Limited
4ti, Jingsteng Building, Xicheng Industrial Zone, Xixiang Road, Bao' an District, Shenzhen, Ghangdong. China
Tel: [phone]

| Indications for use: | person.<br>The electrodes are interchangeable. The application area of electrode pads<br>must be larger than 4cm². The electrode pads are provided by GMDASZ<br>Manufacturing Co., Ltd. with 510(k) cleared Number K092546.<br>TENS:<br>To be used for temporary relief of pain associated with sore and aching<br>muscles in the shoulder, waist, back, neck, upper extremities (arm), and<br>lower extremities (leg) due to strain from exercise or normal household<br>work activities.<br>PMS:<br>It is intended to be used to stimulate healthy muscles in order to improve |
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### 3. Substantial Equivalence to Predicate device:

Detailed comparison data is included in "Section 9 - Substantial Equivalence Discussion" of this 510(k) submission. .

and facilitate muscle performance.

| Parameters | | New Device | Predicate Device |
|-------------|----------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------|
| 1. | 510(k) Number | K121719 | K102598 |
| 2. | Marketing clearance date: | - | May 13, 2011 |
| 3. | Device Name | SM TENS & PMS | Powered Muscle Stimulator, JQ-SC |
| 4. | Manufacturer | Hong Qiangxing (Shenzhen) Electronics<br>Limited | Hi-Dow International, Inc. |
| 5. | Accessories | Self-adhesive electrodes, electrode wires. | Self-adhesive electrodes, electrode wires, |
| | | Battery charger, USB cable. | Battery charger, USB cable |
| 6. | Intended use | TENS (Mode 1, 3, 4, 5, 6): | TENS (Mode 1. 3. 4. 5. 6): |
| | | To be used for temporary relief of pain | To be used for temporary relief of pain |
| | | associated with sore and aching muscles in | associated with sore and aching muscles |
| | | the shoulder, waist, back, neck, upper | in the shoulder, waist, back, neck, upper |
| | | extremities (arm), and lower extremities | extremities (arm), and lower extremities |
| | | (leg) due to strain from exercise or normal | (leg) due to strain from exercise or |
| | | household work activities. | normal household work activities. |
| | | PMS (Mode 1, 2, 3, 6): | PMS (Mode 1, 2, 3, 6): |
| | | It is intended to be used to stimulate healthy | It is intended to be used to stimulate |
| | | muscles in order to improve and facilitate | healthy muscles in order to improve and |
| | | muscle performance. | facilitate muscle performance. |
| 7. | Power Source(s) | DC 3.7V lithium battery | DC 3.7V lithium battery |
| | - Method of Line Current | Type BF | Type BF |
| | Isolation | | |
| | - Patient Leakage Current | - | - |
| | - Normal Condition | 2μA | 2μA |
| | - Single Fault | < 10μA | < 10μA |
| | Condition | | |
| 8. | Average DC current | < 0.01 μA | < 0.01 μA |
| | through electrodes when | | |
| | Tel: [phone] / Url: www.sunmas.hk | | |
| | device is on but no pulses<br>are being applied (µA) | | |
| 9. | Number of Output Modes | 6 | 6 |
| 10. | Number of Output<br>channels: | 2 | 2 |
| | - Synchronous or<br>Alternating? | Synchronous | Synchronous |
| | - Method of Channel<br>Isolation | Voltage transformer Isolation | Voltage transformer Isolation |
| 11. | Timer Range (minutes) | 10 - 60 minutes, 10 min./step | 10 - 60 minutes, 10 min./step |
| 12. | Compliance with Voluntary<br>Standards? | IEC 60601-1, IEC 60601-1-2,<br>IEC 60601-2-10, IEC 62133,<br>FCC 47 CFR Part 18 | IEC 60601-1, IEC 60601-1-2,<br>IEC 60601-2-10 |
| 13. | Waveform | Pulsed, symmetric, biphasic | Pulsed, symmetric, biphasic |
| 14. | Shape | Rectangular, with interphase interval, | Rectangular, with interphase interval |
| 15. | Maximum Output Voltage<br>(volts) | $42V±10% @500Ω$<br>$84V±10% @2kΩ$<br>$130V±10% @10kΩ$ | $62.4V @500Ω$<br>$76V @2KΩ$<br>$84V @10KΩ$ |
| 16. | Maximum Output Current<br>(specify units) | $84mA±10% @500Ω$<br>$42mA±10% @2KΩ$<br>$13mA±10% @10KΩ$ | $124.8mA @500Ω$<br>$38mA @2KΩ$<br>$8.4mA @10KΩ$ |
| 17. | Pulse width (µsec) | 100µs | 100µs |
| 18. | Max. pulse frequency (Hz) | 110Hz | 61.3Hz |
| 19. | Net Charge (µC per pulse) | 0µC @500Ω; Method: Balanced waveform | 0µC @500Ω; Method: Balanced<br>waveform |
| 20. | Maximum Phase Charge,<br>(µC) | 16.8µC @500Ω | 17.92µC @500Ω |
| 21. | Maximum Average Current,<br>(mA) | 0.924mA @500Ω | 1.248mA @500Ω |
| 22. | Maximum Current Density,<br>(mA/cm², r.m.s ) | 0.462mA/cm² @500Ω | 9.92mA/cm² @500Ω |
| 23. | Maximum Average Power<br>Density. (W/cm³) | 9.702mW/cm² @500Ω | 2.72mW/cm²@500Ω |
| | Similarities between New device<br>and Predicate Device: | Same intended use, power supply, components, 6 modes, 2 channels, software controlled,<br>standards, same waveform and wave shape, same pulse width, net charge, similar phase<br>charge and maximum average current | |
| | Differences between New device<br>and Predicate Device: | Different weight and dimensions, different values of Maximum Average Power Density<br>because of different smallest surface area of electrodes;<br>The new device provides safety test report on battery | |
| Conclusion: | | The SM TENS & PMS is substantially equivalent to the Powered Muscle Stimulator,<br>JQ-5C (K102598). This conclusion is based upon comparison on design, technical<br>characteristics, output mode, intended use, and safety standards complied with. Any<br>differences in the technological characteristics do not raise any new safety and<br>effectiveness issues. | |

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**Hong Qiangxing (Shen Zhen) Electronics Limited**

l l one Qiangxing (Shen Zhen) Electronics Limited
4F. Jingcheng Building. Xicheng Industrial Zone. Xixiang Roud. Bao'an District. Shenzhen, Guangdong. China
Tel: [phone]

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Hong Qiangxing (Shen Zhen) Electronics Limited

4F. Jingcheng Building, Xicheng Industrial Zone. Xixiang Road, Bao'an District, Shenzhen, Guangdong, China Tel: [phone] / Url: www.sunmas.hk

#### 4. Safety and Effectiveness of the device:

SM TENS & PMS is safe and effective as the predicate devices cited above.

The new device has passed testing according to the safety standards:

1) IEC 60601-1: 2005, Medical Electrical Equipment - Part 1: General Requirements for Safety 2) IEC 60601-2-10: 2001, Medical electrical equipment - Part 2-10: Particular requirements for the safety of nerve and muscle stimulators;

3) IEC 60601-1-2: 2001, Medical Electrical Equipment - Part 1-2: General Requirements for Safety -

Collateral Standard: Electromagnetic Compatibility -- Requirements and Tests;

4) IEC 62133: 2002, 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

5) FCC 47 CFR Part 18 Telecommunication: Industrial, Scientific, and Medical Equipment; Conducted Emissions

The conclusion drawn from the safety testing is that the new device is substantially equivalent to the predicate device. Furthermore, the new device complies with the recognized standards and performs its intended tasks as well as the legally marketed predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/4/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.

May 14,2013

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

Hong Qiangxing (Shen Zhen) Electronics Limited % Shanghai CV Technology Co., Ltd. Attn: Ms. Doris Dong Room 1706 Yuesha, No. 128 Songle Rd., Songjiang Area Shanghai, 201600 China

Re: K121719

Trade/Device Name: SM TENS & PMS Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: NGX, NUH Dated: April 24, 2013 Received: May 1, 2013

Dear Ms. Dong:

This letter corrects our substantially equivalent letter of May 10, 2013.

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

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Page 2 - Ms. Doris Dong

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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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 Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# Joyce M. Whang -S

for Victor Krauthamer, Ph.D. Acting Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Section 4 Indications for Use Statement

510(k) Number (if known):

Device Name: SM TENS & PMS

### Indications for Use:

TENS:

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:

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

Prescription Use_ (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use __ J (21 CFR 807 Subpart C)

## (PLEASE DO NOT WRITE BELOW LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

| Joyce M. Whang -S |
|---------------------|
| (Division Sign Off) |

Division of Neurological and Physical Medicine Devices (DNPMD)

K121719 510(k) Number

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