TENS & EMS Device

K202866 · Shenzhen Jian Feng Electronic Technology Co., Ltd. · NUH · May 19, 2021 · Neurology

Device Facts

• Record ID: K202866
• Device Name: TENS & EMS Device
• Applicant: Shenzhen Jian Feng Electronic Technology Co., Ltd.
• Product Code: NUH · Neurology
• Decision Date: May 19, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5890
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

TENS: The device is designed to be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm), lower extremities (leg), abdomen and bottom due to strain from exercise or normal household work activities. EMS: The device is designed to be used to stimulate healthy muscles in order to improve or facilitate muscle performance.

Device Story

The TENS & EMS Device (Model FM-B2403) is a portable, battery-powered (3.7V DC) stimulator for OTC use. It delivers programmed electrical pulses via four channels to adhesive electrode pads placed on the skin. The device features 24 operation modes and 20 adjustable intensity levels. It uses a biphasic square waveform to induce minimal muscle contractions. An LCD screen displays program, intensity level, operating time, and channel information. The device is intended for adult patient self-use to manage muscle pain or improve muscle performance. Healthcare providers do not operate the device; however, the output parameters (intensity, mode) are user-controlled. The device benefits patients by providing non-pharmacological pain relief and muscle stimulation. It includes an automatic shut-off feature and patient override control.

Clinical Evidence

Bench testing only. No clinical data provided. Safety and effectiveness were established through compliance with voluntary standards (ANSI/AAMI/ES 60601-1, IEC 60601-1-2, IEC 60601-2-10, IEC 60601-1-11) and biocompatibility testing (ISO 10993-5, ISO 10993-10). Software verification was performed per FDA guidance.

Technological Characteristics

Portable, battery-powered (3.7V lithium) stimulator. Housing: ABS plastic. 4 output channels. Waveform: Biphasic square. Output: Regulated voltage control. Connectivity: Standalone. Standards: ANSI/AAMI/ES 60601-1, IEC 60601-1-2, IEC 60601-2-10, IEC 60601-1-11, ISO 10993-5/10. Software: Microprocessor-controlled with 24 modes and 20 intensity levels.

Indications for Use

Indicated for adults (age ≥ 18) for temporary relief of pain in muscles of shoulder, waist, back, neck, arms, legs, abdomen, and bottom due to exercise or household strain (TENS), and for stimulation of healthy muscles to improve or facilitate muscle performance (EMS).

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

• HIVOX OTC Electrical Stimulator SEM44 (K171803)

Reference Devices

• JQ-5C

Submission Summary (Full Text)

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May 19, 2021

SHenzhen Jianfeng Electronic Technology Co., Ltd. % Iris Lin Account Manager Intertek Testing Services Shenzhen Ltd. Guangzhou. Block E, No.7-2 Guangdong Software Science Park, Caipin Road Guangzhou Science City, GETDD, Guangdong 510700 China

Re: K202866

Trade/Device Name: TENS & EMS Device Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator For Pain Relief Regulatory Class: Class II Product Code: NUH. NGX Dated: February 24, 2021 Received: March 2, 2021

Dear Iris Lin:

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 Heather Dean, PhD Assistant Director, Acute Injury Devices Team 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)

K202866

Device Name TENS and EMS Device

Indications for Use (Describe) TENS:

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

EMS:

The device is designed to be used to stimulate healthy muscles in order to improve or 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

## K202866

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirement of 21 CFR 807.92.

- 1. Type of 510(k) submission: Traditional Date of the summary prepared: May-11-2021
- 2. Submitter's Information

Submitter: SHENZHEN JIAN FENG ELECTRONIC TECHNOLOGY CO., LTD.

- Address: 902, 903 Jialingyu Industrial Building, Da Pu Road, Houting Village, Shajing Town, Baoan District, Shenzhen City, Guangdong Province, China.
Contact Person: Feng Wen

Email: [e-mail]

Tel: [phone] Fax: [phone]

Application Correspondent

Company: SHENZHEN JIAN FENG ELECTRONIC TECHNOLOGY CO., LTD.

Address: 902, 903 Jialinqyu Industrial Building, Da Pu Road, Houting Village, Shajing Town, Baoan District, Shenzhen City, Guangdong Province, China.

Contact Person: Feng Wen

Title: General Manager

Email: [e-mail]

Tel: [phone] Fax: [phone]

#### 3. The Predicate Device Information

| Basic Information | Predicate Device |
|-----------------------|------------------------------------------|
| Manufacturer | HIVOX BIOTEK INC. |
| Device Name and Model | HIVOX OTC Electrical Stimulator<br>SEM44 |
| 510(k) Number | K171803 |
| Product Code | NUH, NGX |
| Panel Code | Physical Medicine, Neurology |
| Regulation Number | 21 CFR 882.5890<br>21 CFR 890.5850 |
| Regulation Class | Class II |

## 4. Subject Device Information

Trade Name: TENS & EMS Device

Common Name: TENS, EMS, Stimulator for pain relief;

Classification Name: Powered muscle stimulator; Transcutaneous electrical nerve stimulator for pain

relief; Nerve muscle stimulator

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Review Panel: Physical Medicine; Neurology Product Code: NUH, NGX Regulation Number: 21CFR882.5890, 21CFR890.5850 Device Classification: Class II Use: Over-the-Counter Use (OTC)

#### 5. Device Description / Design of Device

The subject device (Model: FM-B2403) is a portable, battery powered (lithium battery 3.7V DC) multifunction device offering both Transcutaneous Electrical Nerve Stimulator (TENS) and Powered Muscle Stimulator (EMS) qualities in one device, it can be used for arm, shoulder, neck, back, waist, abdomen, and leg.

4 channels that effectively transfer your desired choice of programmed electrical pulses directly through electrode adhesive pads to the suggested area of the body where the electrodes are placed, causing minimal muscle contractions. There are 24 modes of operations.

The electrode pads are cleared by FDA, and 510(k) number is K092546 for the electrode pads. They are used as an accessory to the TENS or EMS device unit, which transmits electrical current to patient skin. The electrical current is first transmitted via the lead wire or snap button then transmitted to the conductive gel which is adhered to patient skin. The electrode pads are composed of a cover, connector lead wire or snap button, conductive carbon film, conductive hydrogel, and an electrode carrier liner. It is non-sterile and intended for single adult patient (age ≥ 18) multiple application use.

Its output waveform is provided 24 programs and 20 adjustable intensity levels. The LCD screen shows the information of program, level, operating time and channel.

#### 6. Indication for Use

TENS:

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

## EMS:

The device is designed to be used to stimulate healthy muscles in order to improve or facilitate muscle performance.

## 7. Technological characteristics and substantial equivalence

#### 7.1 The following table is the basic characteristic:

| Contents | Subject Device | Predicate Device | SE | |
|--------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------|----|
| Trade Name | TENS & EMS Device | HIVOX OTC Electrical Stimulator | SE | |
| Device Model | FM-B2403 | SEM44 | / | |
| 510(k) Number | K202866 | K171803 | / | |
| Manufacturer | Shenzhen Jian Feng Electronic<br>Technology Co., Ltd. | HIVOX BIOTEK INC. | / | |
| | | 1) 882.5890 | | |
| Regulatory Information | 882.5890, 890.5850 | 2) 890.5850 | / | |
| Classification | Class II | Class II | / | |
| Product code | NUH, NGX | NUH, NGX | / | |
| Panel | Physical Medicine; Neurology | 1) Neurology<br>2) Physical Medicine | / | |
| OTC/RX | OTC | OTC | / | |
| Intended Use | TENS: The device is designed to be<br>used for temporary relief of pain<br>associated with sore and aching<br>muscles in the shoulder, waist, back,<br>neck, upper extremities (arm), lower<br>extremities (leg), abdomen and<br>bottom due to strain from exercise or<br>normal household work activities.<br>EMS: The device is designed to be<br>used to stimulate healthy muscles in<br>order to improve or facilitate muscle<br>performance. | TENS: The device is designed to be<br>used for temporary relief of pain<br>associated with sore and aching<br>muscles in the shoulder, waist,<br>back, neck, upper extremities (arm),<br>lower extremities (leg), abdomen<br>and bottom due to strain from<br>exercise or normal household work<br>activities.<br>EMS: The device is designed to be<br>used for stimulate healthy muscles<br>in order to improve and facilitate<br>muscle performance. | SE | |
| Apply parts of the body | Shoulder, waist, back, neck, upper<br>extremities (arm), lower extremities<br>(leg), abdomen and bottom | Shoulder, waist, back, neck, upper<br>extremities (arm), lower extremities<br>(leg), abdomen and bottom | SE | |
| Power Source | Built-in 3.7V lithium battery | Batteries, 3x1.5V AAA | SE | |
| Number of Output Modes | TENS:19, EMS:5 | TENS: 15 EMS: 35 | SE | |
| Number of Output Channels | 4 | 2 | SE | |
| Synchronous or Alternating | Synchronous | Synchronous | SE | |
| Method of Channel Isolation | By electrical circuit and software | By electrical circuit and software | SE | |
| Regulated Current or<br>Regulated Voltage | Regulated voltage control | Regulated voltage control | SE | |
| Software/Firmware/Microproce<br>ssor Control? | Yes | Yes | SE | |
| Automatic Overload Trip? | No | Yes | SE | |
| Automatic No-Load Trip? | No | Yes | SE | |
| Automatic Shut Off? | Yes | Yes | SE | |
| Patient Override Control? | Yes | Yes | SE | |
| Indicator Display?<br>On/Off Status?<br>Low Battery?<br>Voltage/Current Level? | Yes | Yes | SE | |
| Timer Range (minutes) | 10-80 | 5-100 | | |
| Compliance with Voluntary<br>Standards? | ANSI/AAMI/ES 60601-1<br>IEC60601-1-2<br>IEC 60601-2-10<br>IEC60601-1-11<br>ISO10993-5<br>ISO10993-10 | IEC60601-1<br>IEC60601-1-2<br>IEC 60601-2-10<br>IEC60601-1-11<br>ISO10993-5<br>ISO10993-10 | SE | |
| Compliance* with 21 CFR<br>898? | Yes | Yes | SE | |
| Weight(g) | 82 g | 89 g (including belt clip, without<br>batteries),<br>123 g (including belt clip and<br>batteries) | SE | |
| Dimensions (mm) [D x W H] | 110*60*15 | 132 x 63 x 29.5 mm<br>(including belt clip) | SE | |
| Housing Materials and<br>Construction | ABS | ABS | SE | |
| Contents | Subject Device | Predicate Device | Additional-Predicate<br>Device | SE |
| Device Name, Model | FM-B2403 | SEM44 | JQ-5C | / |
| Waveform (e.g., pulsed<br>monophasic, biphasic) | biphasic | biphasic | biphasic | SE |
| Shape (e.g., rectangular,<br>spike, rectified sinusoidal) | Square | Square | Rectangular | SE |
| Maximum Output Voltage<br>(volts) (+/- 10%) | 97.6@500Ω<br>135@2KΩ<br>157@10KΩ | 100volts peak-<br>peak±10%@500Ω<br>180volts peak-<br>peak±10%@2kΩ<br>250volts peak-<br>peak±10%@10KΩ | 62@500Ω | SE |
| Maximum Output Current<br>(mA) (+/- 10%) | 195.2@500Ω<br>67.5@2KΩ<br>15.7@10KΩ | 200mA peak-<br>peak±10% @500Ω<br>90mA peak-peak±10%<br>@2kΩ<br>25mA peak-peak±10%<br>@10kΩ | 124@500Ω<br>37.6@2KΩ | SE |
| Pulse Duration (µsec) | 90µS | 50-450µS | 100µS | SE |
| Frequency† (Hz) [or<br>Rate† (pps)] | < 90.9Hz | 1-150Hz | 61Hz | SE |
| Net Charge (micro<br>coulombs (µC) per pulse)<br>(If zero, state method of<br>achieving zero net<br>charge.) | 0.001@500Ω | 0.001@500Ω | 0 | SE |
| Maximum Phase Charge,<br>(µC) | 15.5@500Ω | 45@500Ω | 17.92µC | SE |
| Maximum Current<br>Density(mA/cm2) | 0.1192@500Ω | 0.667@500Ω | 9.95 mA/cm² | SE |
| Maximum Power<br>Density(mW/cm2) | 0.176@500Ω | 4.6@500Ω | 2.7 | SE |
| Pulses per burst | 2 | 3 | Not publicly available | SE |
| Bursts per second | 1/30 | 2/60 | Not publicly available | SE |
| Burst duration (ms) | 45 | 36 | Not publicly available | SE |
| Duty Cycle: Line (b) x Line<br>(%) | 0.016 | 36ms/390ms | Not publicly available | SE |
| ON Time (seconds) | 1 | 2 | Not publicly available | SE |
| OFF Time (seconds) | 1 | 2 | Not publicly available | SE |
| Standard/Guidance<br>Document Referenced | ANSI/AAMI/ES 60601-1<br>IEC60601-1-2<br>IEC60601-1-11<br>IEC 60601-2-10<br>ISO 10993-5:2009<br>ISO 10993-10:2010 | IEC 60601-1<br>IEC 60601-1-2<br>IEC 60601-2-10<br>ISO10993-5/10 | Not publicly available | SE |

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## 7.2The following table is the output parameters:

## 8. Non-Clinical Tests Performed

Compliance to applicable voluntary standards include: ANSI/AAMI/ES 60601-1, IEC60601-1-2, IEC 60601-2-10, IEC60601-1-11.

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In addition to the compliance of voluntary standards, the software verification has been carried out according to the FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.

#### 9. Conclusion:

After analyzing non-clinical laboratory studies and safety testing data, it can be concluded that the EMS and TENS Devices (Model FM-B2403) is substantially equivalent to the predicate device (Model: SEM44).