ELECTRONIC PULSE STIMULATOR

K141260 · Shenzhen Jingkehui Electronic Co.., Ltd. · NUH · Sep 17, 2014 · Neurology

Device Facts

• Record ID: K141260
• Device Name: ELECTRONIC PULSE STIMULATOR
• Applicant: Shenzhen Jingkehui Electronic Co.., Ltd.
• Product Code: NUH · Neurology
• Decision Date: Sep 17, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5890
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

Electronic Pulse Stimulator is a compact, portable, microprocessor-controlled Transcutaneous Electrical Nerve Stimulator (TENS). Device delivers gentle electrical pulses to user's skin via adhesive electrode pads. User adjusts pulse intensity via front control panel. Intended for over-the-counter use to provide temporary relief of pain in shoulder, waist, back, arm, and leg muscles caused by exercise or daily activities. Device operates by activating underlying nerves through electrical stimulation. Benefits include non-invasive, temporary pain management for muscle soreness.

Clinical Evidence

No clinical data. Substantial equivalence established via bench testing and compliance with voluntary standards including IEC 60601-1, IEC 60601-1-2, and IEC 60601-2-10.

Technological Characteristics

Microprocessor-controlled TENS device; delivers electrical pulses via adhesive electrode pads. Output modes vary by voltage, current, frequency, and pulse width. Standards: IEC 60601-1 (General safety), IEC 60601-1-2 (EMC), IEC 60601-2-10 (Nerve/muscle stimulators). Biocompatible electrodes used. Connectivity: Standalone.

Indications for Use

Indicated for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, arm, and leg, due to strain from exercise or normal household and work activities in adult patients.

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

• Electronic Pulse Stimulator (K131921)
• IQ Technologies (K131290)

Submission Summary (Full Text)

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

September 17, 2014

Shenzhen Jingkehui Electronic Co. LTD c/o Bill Quanqin Dai, Ph.D. Application Correspondent 513 Piazza Drive, Unit B Mountain View, CA, 94043

Re: 510(k) Number: K141260 Trade/Device Name: Electronic Pulse Stimulator Regulation Number: 21 CFR 882.5890 Regulation Name: Neurology Regulatory Class: Class II Product Code: NUH Dated: Aug 16th 2014 Received: Aug 20th 2014

Dear Dr. Dai.

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 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

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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 801), please contact the Division of Industry and Consumer Education 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

# Felipe Aguel -S

Carlos Pena, Ph.D. for

Director- Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) K141260

Device Name

Electronic Pulse Stimulator

#### Indications for Use (Describe)

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

Type of Use (Select one or both, as applicable)

- Prescription Use (Part 21 CFR 801 Subpart D)

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

#### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

#### FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

## Date: 2014.09.17 15:39:53 -04'00'

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#### 510(k) Summary

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

#### 1. Submitter's Information

Submitter: Shenzhen Jingkehui Electronic Co., Ltd. Address: 5F, Building 12, Hengmingzhu Industrial Park, Xiangxing Road, Shajing, Baoan District, Shenzhen, China Contact Person: Pu Jiang Tel: [phone] Fax: [phone] Email: [e-mail] Date of Preparation: 05/12/2014

#### 2. Subject Device

Trade/Device Name: Electronic Pulse Stimulator Common Name: Transcutaneous electrical nerve stimulator (TENS) Regulation Description: Transcutaneous electrical nerve stimulator for pain relief Definition: Temporary relief of pain due to sore/aching muscles Regulation Medical Specialty: Neurology Review Panel: Neurology Product Code: NUH Regulation Number: 21 CFR 882.5890 Device Class: II Use: Over-The-Counter

#### 3. Predicate device

Predicate Device: Electronic Pulse Stimulator 510(k) Number: K131921 Use: Over-The-Counter Submitter: Shenzhen Jingkehui Electronic Co., Ltd.

Predicate Device: IQ Technologies 510(k) Number: K131290 Use: Over-The-Counter Submitter: IO Technologies Inc.

#### 4. Description of Subject Device

The subject device is a Transcutaneous Electrical Nerve Stimulator (TENS), intended for the over-thecounter use to temporarily relieve pain in different body areas. The subject device, which is compact, portable, and microprocessor-controlled, delivers a gentle electrical pulse to the user's skin through the electrode pads for pain relief. According to the need of users, the pulse intensity can be adjustable on the front control panel of the device.

## 5. Intended Use of Subject Device

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

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### 6. Summary of Substantial Equivalence

The following table summarizes the comparison between the subject device and predicate devices, indicating the technical characteristics of the subject device are substantially equivalent to those of the predicate devices.

| Parameter | Subject Device | Subject Device | Predicate Device | Predicate Device |
|------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------|----------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K141260 | K141260 | K131921 | K131290 |
| Device Name/Model | Electronic<br>Pulse<br>Stimulator/PL-029BL | Electronic<br>Pulse<br>Stimulator/PL-029K | Electronic<br>Pulse<br>Stimulator/PL-029 | IQ Technologies |
| Maximum output<br>voltage (Volts +/-<br>20%) at 500Ω | Mode 1: 41.6<br>Mode 2: 66.4<br>Mode 3: 60.8<br>Mode 4: 35.2<br>Mode 5: 32.8<br>Mode 6: This mode<br>cycles the above<br>modes<br>Mode 7: 75.2<br>Mode 8: 24.0 | Mode 1: 46.0<br>Mode 2: 59.6<br>Mode 3: 49.2<br>Mode 4: 64.8<br>Mode 5: 37.2<br>Mode 6: This mode<br>cycles the above<br>modes<br>Mode 7: 71.2<br>Mode 8: 64.0 | 49.6 | Mode 1: 42<br>Mode 2: 63.2<br>Mode 3: 64<br>Mode 4: 34.4<br>Mode 5: 32<br>Mode 6: This<br>mode cycles the<br>above modes |
| Maximum output<br>voltage (Volts +/-<br>20%) at 2ΚΩ | Mode 1: 80.0<br>Mode 2: 100<br>Mode 3: 83.2<br>Mode 4: 70.4<br>Mode 5: 67.2<br>Mode 6: This mode<br>cycles the above<br>modes<br>Mode 7: 121<br>Mode 8: 46.4 | Mode 1: 86.4<br>Mode 2: 111<br>Mode 3: 80<br>Mode 4: 90.4<br>Mode 5: 64.8<br>Mode 6: This mode<br>cycles the above<br>modes<br>Mode 7: 122<br>Mode 8: 89.6 | 99.2 | Mode 1: 80.8<br>Mode 2: 94.4<br>Mode 3: 87.2<br>Mode 4: 68<br>Mode 5: 64<br>Mode 6: This<br>mode cycles the<br>above modes |
| Maximum output<br>voltage (Volts +/-<br>20%) at 10kΩ | Mode 1: 125<br>Mode 2: 128<br>Mode 3: 84.8<br>Mode 4: 123<br>Mode 5: 116<br>Mode 6: This mode<br>cycles the above<br>modes<br>Mode 7: 134<br>Mode 8: 85.6 | Mode 1: 116<br>Mode 2: 146<br>Mode 3: 138<br>Mode 4: 106<br>Mode 5: 111<br>Mode 6: This mode<br>cycles the above<br>modes<br>Mode 7: 136<br>Mode 8: 96.8 | 114 | Mode 1: 129<br>Mode 2: 129<br>Mode 3: 96.8<br>Mode 4: 128<br>Mode 5: 119<br>Mode 6: This<br>mode cycles the<br>above modes |
| Maximum output<br>current (mA +/- 20%)<br>at 500Ω | Mode 1: 83.2<br>Mode 2: 132.8<br>Mode 3: 121.6<br>Mode 4: 70.4<br>Mode 5: 65.6<br>Mode 6: This mode<br>cycles the above<br>modes | Mode 1: 92.0<br>Mode 2: 119.2<br>Mode 3: 98.4<br>Mode 4: 129.6<br>Mode 5: 74.4<br>Mode 6: This mode<br>cycles the above<br>modes | 18 | Mode 1: 84<br>Mode 2: 126.4<br>Mode 3: 128<br>Mode 4: 68.8<br>Mode 5: 64<br>Mode 6: This<br>mode cycles the |
| | modes | modes | | above modes |
| | Mode 7: 150.4 | Mode 7: 142.4 | | |
| | Mode 8: 48.0 | Mode 8: 128.0 | | |
| Maximum output<br>current (mA +/- 20%)<br>at 2ΚΩ | Mode 1: 40.0 | Mode 1: 43.2 | 3.2 | Mode 1: 40.4 |
| | Mode 2: 50 | Mode 2: 55.5 | | Mode 2: 47.2 |
| | Mode 3: 41.6 | Mode 3: 40 | | Mode 3: 43.6 |
| | Mode 4: 35.2 | Mode 4: 45.2 | | Mode 4: 34 |
| | Mode 5: 33.6 | Mode 5: 32.4 | | Mode 5: 32 |
| | Mode 6: This mode<br>cycles the above<br>modes | Mode 6: This mode<br>cycles the above<br>modes | | Mode 6: This<br>mode cycles the<br>above modes |
| | Mode 7: 60.5 | Mode 7: 61 | | |
| | Mode 8: 23.2 | Mode 8: 44.8 | | |
| Maximum output<br>current (mA +/- 20%)<br>at 10KΩ | Mode 1: 12.5 | Mode 1: 11.6 | 0.6 | Mode 1: 12.9 |
| | Mode 2: 12.8 | Mode 2: 14.6 | | Mode 2: 12.9 |
| | Mode 3: 8.5 | Mode 3: 13.8 | | Mode 3: 9.7 |
| | Mode 4: 12.3 | Mode 4: 10.6 | | Mode 4: 12.8 |
| | Mode 5: 11.6 | Mode 5: 11.1 | | Mode 5: 11.9 |
| | Mode 6: This mode<br>cycles the above<br>modes | Mode 6: This mode<br>cycles the above<br>modes | | Mode 6: This<br>mode cycles the<br>above modes |
| | Mode 7: 13.4 | Mode 7: 13.6 | | |
| | Mode 8: 8.6 | Mode 8: 9.7 | | |
| Pulse Width (μSec) | 100 | 50~100 | 50~140 | 100 |
| Pulse period (mSec) | 6.1~824 | 12~832 | 40 | 10~840 |
| Frequency (Hz) | Mode 1: 69.4 | Mode 1: 54.3 | 86 | Mode 1: 69.4 |
| | Mode 2: 12.8~53.2 | Mode 2: 35.7 | | Mode 2: 12.3~54.3 |
| | Mode 3: 1.2 | Mode 3: 62.5 | | Mode 3: 1.2 |
| | Mode 4: 96.2 | Mode 4: 6.7 | | Mode 4: 100 |
| | Mode 5: 96.2 | Mode 5: 83.3 | | Mode 5: 100 |
| | Mode 6: This mode<br>cycles the above<br>modes | Mode 6: This mode<br>cycles the above<br>modes | | Mode 6: This<br>mode cycles the<br>above modes |
| | Mode 7: 19.2 | Mode 7: 19.8 | | |
| | Mode 8: 164.4 | Mode 8: 1.2 | | |
| Maximum Phase<br>charge (µC) at 500Ω | Mode 1: 17.3 | Mode 1: 19.9 | 23 | Mode 1: 18.1 |
| | Mode 2: 24.4 | Mode 2: 6.0 | | Mode 2: 27.3 |
| | Mode 3: 24.3 | Mode 3: 4.9 | | Mode 3: 25.6 |
| | Mode 4: 14.6 | Mode 4: 6.5 | | Mode 4: 14.9 |
| | Mode 5: 12.6 | Mode 5: 3.7 | | Mode 5: 12.8 |
| | Mode 6: This mode<br>cycles the above<br>modes | Mode 6: This mode<br>cycles the above<br>modes | | Mode 6: This<br>mode cycles the<br>above modes |
| | Mode 7: 31.3 | Mode 7: 33.0 | | |
| | Mode 8: 9.2 | Mode 8: 25.6 | | |
| Maximum current<br>density (mA/cm2) | Mode 1: 3.33 | Mode 1: 5.75 | 1.4 | Mode 1: 3.36 |

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| 500Ω | Mode 3: 4.86<br>Mode 4: 2.82<br>Mode 5: 2.62<br>Mode 6: This mode cycles the above modes<br>Mode 7: 6.02<br>Mode 8: 1.92 | Mode 3: 6.15<br>Mode 4: 8.10<br>Mode 5: 4.65<br>Mode 6: This mode cycles the above modes<br>Mode 7: 8.90<br>Mode 8: 8.00 | 0.23 | Mode 3: 5.12<br>Mode 4: 2.75<br>Mode 5: 2.56<br>Mode 6: This mode cycles the above modes |
|------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|------|-------------------------------------------------------------------------------------------------------------------------------|
| Maximum average power density (mW/cm²) at 500Ω | Mode 1: 2.00<br>Mode 2: 0.83~3.45<br>Mode 3: 0.07<br>Mode 4: 1.98<br>Mode 5: 1.59<br>Mode 6: This mode cycles the above modes<br>Mode 7: 1.81<br>Mode 8: 1.45 | Mode 1: 3.10<br>Mode 2: 0.79<br>Mode 3: 0.95<br>Mode 4: 0.18<br>Mode 5: 0.72<br>Mode 6: This mode cycles the above modes<br>Mode 7: 2.91<br>Mode 8: 0.12 | | Mode 1: 2.11<br>Mode 2: 0.85~3.75<br>Mode 3: 0.08<br>Mode 4: 2.05<br>Mode 5: 1.64<br>Mode 6: This mode cycles the above modes |

## 7. Substantial Equivalence

The operational principle of the above predicate device is to generate small pulses of electrical current and deliver the pulses to the user's skin through adhesive electrode pads such that the underlying nerves are activated and the pain associated with sore and aching muscles is temporarily relieved.

Identically, the subject device generates small pulses of electrical current and delivers the pulses to the user's skin through adhesive electrode pads such that the underlying nerves are activated and the pain associated with sore and aching muscles is temporarily relieved.

The comparison between the subject device and predicate devices demonstrates the technical characteristics, specifications, and intended use of the subject device are substantially equivalent to those of the predicate devices.

The differences, such the output voltage and current, between the subject device and the predicate devices are insignificant in terms of safety or effectiveness. The verification and validation tests, such as IEC 60601-1, IEC 60601-1-2, and IEC 60601-2-10, further demonstrate these differences maintain the same safety and effectiveness as those of the 510(k) cleared predicate devices. In other words, these differences do not affect the intended use or alter the fundamental technology of the device. There are no new safety or effectiveness issues concerning the subject device, which offers substantially equivalent technical specifications, features, intended use, and effective results as the predicate devices.

Concerns of the safe and proper use of the biocompatible electrode pads have been fully addressed by making the use conscious of the proper placement of the electrode pads and appropriate operations of the device through details in the labeling.

#### 8. Non-Clinical Tests Performed

The subject device does not conduct, nor rely upon, clinical tests to determine substantial equivalence. Non-clinical tests were performed on the subject device in order to validate the design and to assure

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conformance with the following voluntary design standards in connection with medical device electrical safety, and electromagnetic compatibility.

- (a) IEC 60601-1 "Medical Electrical Equipment Part 1: General requirements for basic safety and essential performance".
- (b) IEC 60601-1-2 "Medical Electrical Equipment Part 1-2: General Requirements for Basic Safety and Essential Performance - Collateral standard: Electromagnetic Compatibility - Requirements and Tests".
- (c) IEC 60601-2-10 "Medical electrical equipment Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators".

In addition to the compliance of voluntary standards, the verification of software used in the subject device has been carried out according to the FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices. The biocompatible electrodes, as the accessory of the subject device, also meet the requirement of safety.

#### 9. Conclusion

The tests performed and the comparison of technical characteristics, specifications, and intended use demonstrate the subject device is substantially equivalent to the predicate device. Therefore, the subject device is as safe and effective as the foregoing identified OTC predicate devices that have been legally marketed in the United States.