Digital TENS Unit

K170145 · Shenzhen Eapply Technology Co., Ltd. · NUH · Apr 29, 2017 · Neurology

Device Facts

• Record ID: K170145
• Device Name: Digital TENS Unit
• Applicant: Shenzhen Eapply Technology Co., Ltd.
• Product Code: NUH · Neurology
• Decision Date: Apr 29, 2017
• 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

Digital TENS Unit is a compact, portable, microprocessor-controlled transcutaneous electrical nerve stimulator. It delivers gentle electrical pulses to the user's skin via pad lead cords and electrode gel pads. The device is intended for over-the-counter use. Users operate the device via an interface to adjust pulse intensity. It functions by providing electrical stimulation to muscles to provide temporary pain relief. The device includes features such as automatic shut-off, automatic no-load trip, and low battery indicators. It is powered by a rechargeable 3.7V lithium battery.

Clinical Evidence

Bench testing only. Evidence includes biocompatibility testing (ISO 10993-5, ISO 10993-10), electromagnetic compatibility (IEC 60601-1-2), electrical safety (IEC 60601-1, IEC 60601-2-10, IEC 60601-1-11), software verification and validation, and waveform output verification per FDA guidance.

Technological Characteristics

Microprocessor-controlled TENS device; DC 3.7V rechargeable lithium battery; ABS plastic housing; 2 output channels (synchronous); regulated voltage output; 6 output modes; pulse width 94 µs; frequency 1.2-100Hz; waveform: pulsed symmetric biphasic/monophasic; connectivity: none; sterilization: not specified.

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.

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 (K141260)
• Electronic Pulse Stimulator, Model:MDTS100 (K160508)
• Tyece OTC TENS Device, Model SEM44 (K150386)
• 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

April 29, 2017

Shenzhen Eapply Technology Co., Ltd Lisa Huang Business Manager 3rd Floor, 2nd Building, Hezhou New Industrial Area Xixiang Town Shenzhen City, 518000 CN

Re: K170145/S001

Trade/Device Name: Digital Tens Unit (Model: 1653195) Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator For Pain Relief Regulatory Class: Class II Product Code: NUH Dated: March 31, 2017 Received: April 07, 2017

Dear Lisa Huang:

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

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Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated 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 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" (21 CFR 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.

William J.

Heetderks -S

Digitally signed by William J. Heetderks -S
DN: c=US, o=U.S. Government, ou=HHS, ou=FDA, ou=People,
0.9.2342.19200300.100.1.1=0010149848, cn=William J. Heetderks -S
Date: 2017.04.29 17:34:11 -04'00'

for Carlos L. Peña, PhD, MS 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)

K170145 1

#### Device Name Digital TENS Unit (Model: 1653195)

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)

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

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# 510(k) Summary

"510(k) Summary" as required by section 807.92(c).

### 1. Submitter Information

- 510(k) Owner's Name: Shenzhen Eapply Technology Co., Ltd
- Establishment Registration Number: Applying
- . Address: 3rd floor, 2nd building, Hezhou New Industrial Area, Xixiang Town, Shenzhen City, Guangdong Province, China
- Postal Code: 518000 .
- Tel: [phone]
- . Fax: [phone]
- Contact Person: Lisa Huang
- Title: Business manager
- Tel: [phone] ext.817
- Fax: [phone]
- Email: [e-mail]

# 2. Subject Device Information

- . Digital TENS Unit (Model: 1653195) Trade Name:
- Common Name: Transcutaneous electrical nerve stimulator
- . Classification name: Transcutaneous electrical nerve stimulator for pain relief
- . Review Panel: Neurology
- . NUH Product Code:
- II Regulation Class:
- 882.5890 ● Regulation Number:

#### 3. Predicate Device Information

| | Shenzhen<br>Jingkehui<br>Electronic Co.<br>LTD | Beijing Choice<br>Electronic Technology Co.,<br>Ltd. | Tyece Ltd. | IQ<br>Technologies<br>Inc. |
|----------------------------------|------------------------------------------------|------------------------------------------------------|------------------------------------------|----------------------------|
| <b>Sponsor</b> | | | | |
| <b>Device Name<br/>and Model</b> | Electronic Pulse<br>Stimulator | Electronic Pulse<br>Stimulator,<br>Model:MDTS100 | Tyece OTC<br>TENS Device,<br>Model SEM44 | IQ<br>Technologies |

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| 510(k)<br>Number | K141260 | K160508 | K150386 | K131290 |
|----------------------|-----------------|-----------------|-----------------|-----------------|
| Product Code | NUH | NUH | NUH | NUH |
| Regulation<br>Number | 21 CFR 882.5890 | 21 CFR 882.5890 | 21 CFR 882.5890 | 21 CFR 882.5890 |
| Regulation<br>Class | II | II | II | II |

#### 2. Device Description

Digital TENS Unit is a Transcutaneous Electrical Nerve Stimulator (TENS), intended for the over-the-counter use to relieve pain in different body areas (neck, shoulders, back, waists, arms, and legs). At the same time, the proposed TENS device, which is compact, portable, and microprocessor-controlled, delivers a gentle electrical pulse through the Pad Lead Cords and Electrode Gel Pads to the uses' skin for pain relief. to the user's skin through the pad lead cords and electrode gel pads to the user's skin for pain relief. According to the need of users, the pulse intensity can be adjustable on the Controller's interface of the device.

#### 5. Intended Use / Indications for 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.

#### 6. Test Summary

Digital TENS Unit has been evaluated the safety and performance as following:

- Biocompatibility test according to ISO 10993-5 and ISO 10993-10 standards
- Electromagnetic compatibility test according to IEC 60601-1-2 standard
- Electrical safety test according to IEC 60601-1, IEC 60601-2-10 and IEC 60601-1-11 standards
- . Software verification and validation test according to the requirements of the FDA "Guidance for Pre Market Submissions and for Software Contained in Medical Devices"
- . The waveform test report has also been conducted to verify the output specifications of the device according to Guidance for Transcutaneous Electrical Nerve Stimulator for Pain Relief Intended for Over the Counter Use

# 7. Comparison to predicate device and conclusion

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The technological characteristics, features, specifications, materials, mode of operation, and intended use of the subject device is substantially equivalent to the predicate devices quoted above. The differences between the subject device and predicate devices do not raise new issues of safety or effectiveness.

| Comparison<br>Items | Subject<br>Device | Predicate Device | | | | Remark | |
|------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------|--------------|
| Device Name<br>and Model | Digital TENS<br>Unit | Electronic<br>Pulse<br>Stimulator | Electronic<br>Pulse<br>Stimulator,<br>Model:MDTS1<br>00 | Tyece<br>TENS<br>Model SEM44 | OTC IQ<br>Device, Technologies | -- | |
| 510(k)<br>Number | Applying | K141260 | K160508 | K150386 | K131290 | -- | |
| Intended Use | To be used for<br>temporary<br>relief of pain<br>associated<br>with sore and<br>aching<br>muscles in the<br>shoulder,<br>waist, back,<br>arm, and leg,<br>due to strain<br>from exercise<br>or normal<br>household<br>and work<br>activities. | To be used for<br>temporary<br>relief of pain<br>associated<br>with sore and<br>aching<br>muscles in the<br>shoulder,<br>waist, back,<br>arm, and leg,<br>due to strain<br>from exercise<br>or normal<br>household<br>and work<br>activities. | The Electronic<br>Pulse<br>Stimulator<br>MDTS100 is<br>to be used for<br>temporary<br>relief of pain<br>associated<br>with sore and<br>aching<br>muscles in the<br>shoulder,<br>waist, back,<br>upper<br>extremities<br>(arm), and<br>lower<br>extremities<br>(leg) due to<br>strain from<br>exercise or<br>normal<br>household<br>activities. | The Tyece OTC<br>TENS Device,<br>Model SEM44<br>is to be used for<br>temporary relief<br>of pain<br>associated with<br>sore and aching<br>muscles in the<br>lower back,<br>arms, or legs<br>due to strain<br>from exercise or<br>normal<br>household<br>activities. | TENS:<br>To be used for<br>temporary<br>relief of pain<br>associated with<br>sore and aching<br>muscles in the<br>shoulder, waist,<br>back, upper<br>extremities<br>(arm), and SE<br>lower<br>extremities<br>(leg) due to<br>strain from<br>exercise or<br>normal<br>household<br>work activities. | -- | |
| Comparison<br>Items | Subject<br>Device | Predicate Device | | | | Remark | |
| | | | normal<br>household and<br>work<br>activities. | | PMS:<br>It is intended to<br>be used to<br>stimulate<br>healthy<br>muscles in<br>order to<br>improve and<br>facilitate<br>muscle<br>performance. | | |
| Basic Unit Specifications | | | | | | | |
| Power<br>Source(s) | DC 3.7V<br>Lithium<br>Battery(rechargeable) | | DC 3V, 2<br>AAA batteries | 4.5V(batteries,<br>3x1.5V AM) | DC 3.7V SE<br>Lithium<br>Battery(rechargeable) | | |
| Method of<br>Line Current<br>Isolation | Not<br>applicable for<br>DC current | | Not applicable<br>for DC current | Not applicable<br>for DC current | Not applicable SE<br>for DC current | | |
| Patient<br>Leakage<br>Current | -- | | -- | -- | -- | | |
| -Normal<br>Condition<br>(μΑ) | 0.7<10μΑ | | ≤10μΑ | Not applicable | | SE | |
| - Single Fault<br>Condition(μΑ<br>) | 0.7<50μΑ | | ≤50μΑ | Not applicable | | SE | |
| Number<br>of<br>Output Modes | 6 | | 7 | 15 | 6 | SE | |
| Comparison<br>Items | Subject<br>Device | Predicate Device | | | Remark | | |
| Number of<br>Output<br>Channels | 2 | / | 2 | 2 | 2 | SE | |
| -Synchronous<br>or<br>Alternating? | Synchronous | / | Alternating | Synchronous | / | SE | |
| -Method of<br>Channel<br>Isolation | No | / | No | PCB Insulation<br>Boost Isolation | No | SE | |
| Regulated<br>Current or<br>Regulated<br>Voltage? | Regulated<br>Voltage | / | Regulated<br>Voltage | Regulated<br>Voltage | Regulated<br>Voltage | SE | |
| Software/Fir<br>mware/Micro<br>processor<br>Control? | Yes | / | Yes | Yes | Yes | SE | |
| Automatic<br>Overload<br>Trip? | No | / | No | No | No | SE | |
| Automatic<br>No-Load<br>Trip? | Yes | / | Yes | Yes | No | SE | |
| Automatic<br>Shut Off? | Yes | / | Yes | Yes | Yes | SE | |
| User Override<br>Control | Yes | / | Yes | Yes | Yes | SE | |
| Indicat -<br>or On/O | Yes | / | Yes | Yes | Yes | SE | |
| Comparison<br>Items | Subject<br>Device | Predicate Device | | | | Remark | |
| Display ff:<br>Status? | | | | | | | |
| | Yes | Yes | Yes | Yes | Yes | SE | |
| | Low<br>Battery? | | | | | | |
| | -Volt<br>age/<br>Current<br>Level? | Yes for<br>Voltage | Yes | Yes | Yes for Voltage | Yes | SE |
| Timer<br>(Min) | Range 10, 20, 30,/<br>40, 50 and 60 | | 20 | | 5-100 | 10 to 60 | SE |
| Weight | 35g (1.2 oz,/<br>Battery<br>Included) | | 62.3 g(2.2 oz,/<br>Battery<br>Excluded) | | / | | SE<br>Note 1 |
| Dimensions<br>(W x H x D) | 84.93mm x/<br>43mm x<br>10.3 mm | | 661 mm x<br>1560 mm x<br>265 mm(2.17<br>in. x 5.12 in. x<br>0.87 in.) | x 135 mm x 65 mm/<br>x x 20 mm | | | SE<br>Note 1 |
| Housing<br>Materials and<br>Construction | ABS | | ABS | | ABS | | SE |
| Compliance<br>with<br>Voluntary<br>Standards | IEC 60601-1,<br>IEC<br>60601-1-2,<br>IEC 60601-2- | IEC 60601-1,<br>IEC<br>60601-1-2,<br>IEC 60601-2- | IEC 60601-1,<br>IEC<br>60601-1-2,<br>60601-2- | IEC 60601-1,<br>IEC<br>60601-1-2,<br>60601-2- | | IEC 60601-1, SE<br>IEC<br>IEC 60601-1-2, IEC<br>60601-2- | |
| Comparison<br>Items | Subject<br>Device | Predicate Device | | | | | Remark |
| | IEC 10,<br>60601-1-11,<br>ISO 10993-5<br>and -10 | IEC 10,<br>60601-1-11,<br>ISO 10993-5<br>and -10 | IEC 10,<br>60601-1-11,<br>ISO 10993-5<br>and -10 | IEC 10,<br>60601-1-11,<br>ISO 10993-5<br>and -10 | IEC 10,<br>60601-1-11,<br>ISO 10993-5<br>and -10 | IEC<br>10993-5 | |
| Compliance<br>with 21 CFR<br>898 | Yes | Yes | Yes | Yes | Yes | Yes | SE |
| Output Specifications | | | | | | | |
| Waveform | Pulsed<br>symmetric,<br>biphasic/<br>Pulsed<br>monophasic | / | Pulsed<br>monophasic | Biphasic | Pulsed | | SE |
| Shape | Rectangular | / | Rectangular | Rectangular | Rectangular | | SE |
| Maximum<br>Output<br>Voltage | 58 V @ 500 Ω<br>86 V @ 2k Ω<br>142V @ 10k Ω | 75.2V@500Ω<br>121V @2kΩ<br>134V@10kΩ | 150V@500Ω<br>160V @2kΩ<br>165V@10kΩ | 70V @500 Ω<br>110V @2kΩ<br>190V@10kΩ | 64V@500 Ω<br>94,4V @2kΩ<br>129V@10kΩ | | SE |
| Maximum<br>Output<br>Current | 116 mA @<br>500 Ω<br>43 mA @ 2k Ω<br>14.2 mA @<br>10k Ω | 121.6 mA<br>@500Ω<br>60.5 mA<br>@2kΩ<br>13.4 mA<br>@10kΩ | 300 mA<br>@500Ω<br>80 mA @2kΩ<br>16.5 mA<br>@10kΩ | 86 mA@50Ω<br>23.3 mA@2KΩ<br>3.75 mA@10KΩ | 128mA@50Ω<br>47.2<br>mA@2KΩ<br>12.9<br>mA@10KΩ | | SE |
| Pulse Width | 94 µs | 100 µs | 50~140 µs | 50~360 µs | 100 µs | | SE |
| Pulse<br>frequency | 1.2~100Hz | 1.2Hz~164.4<br>Hz | 0.9Hz~82Hz | 1-150Hz | 1.2~100Hz | | SE |
| Net Charge<br>(per pulse) | 0 µC @<br>500Ω/ | / | 42µC@ 500Ω | 0.001 µC<br>500Ω | 0 µC @ 500Ω | | SE |

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