Digital TENS Unit

• K Number: K170145
• Device Name: Digital TENS Unit
• Manufacturer: SHENZHEN EAPPLY TECHNOLOGY CO., LTD
• Date Cleared: 2017-04-29 ( 102 days)
• Product Code: NUH
• Regulation Number: 882.5890

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 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.

Predicate Devices

K141260, K160508, K150386, K131290

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a standard TENS unit with adjustable pulse intensity controlled by a microprocessor. There is no mention of AI or ML in the device description, intended use, or performance studies.

Therapeutic

Yes

The device is intended for "temporary relief of pain associated with sore and aching muscles," which is a therapeutic purpose.

Diagnostic

No

Explanation: The device is described as a Transcutaneous Electrical Nerve Stimulator (TENS) intended for pain relief by delivering electrical pulses, not for identifying, monitoring, or diagnosing a medical condition.

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a "Digital TENS Unit" that delivers electrical pulses through "Pad Lead Cords and Electrode Gel Pads," indicating it includes hardware components beyond just software. The performance studies also include hardware-related tests like biocompatibility, electromagnetic compatibility, and electrical safety.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• Intended Use: The intended use is for the temporary relief of pain associated with sore and aching muscles. This is a therapeutic purpose, not a diagnostic one.
• Device Description: The device is a Transcutaneous Electrical Nerve Stimulator (TENS) that delivers electrical pulses to the skin for pain relief. This is a physical therapy modality, not a method for examining specimens from the human body.
• Lack of IVD Characteristics: The description does not mention any analysis of biological samples (blood, urine, tissue, etc.) or any diagnostic purpose.

IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This TENS unit does not fit that definition.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

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.

Product codes

NUH

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

shoulder, waist, back, arm, and leg

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Over-The-Counter Use

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

• 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

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K141260, K160508, K150386, K131290

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 882.5890 Transcutaneous electrical nerve stimulator for pain relief.

(a)
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.(b)
Classification. Class II (performance standards).

Summary

0

Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of two main elements: a circular seal on the left and a stylized symbol on the right. The circular seal contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. The symbol on the right features three stylized human profiles facing right, stacked on top of each other, creating a sense of depth and unity.

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

1

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

2

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

3

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

4

| 510(k)

Number	K141260	K160508	K150386	K131290
Product Code	NUH	NUH	NUH	NUH
Regulation
Number	21 CFR 882.5890	21 CFR 882.5890	21 CFR 882.5890	21 CFR 882.5890
Regulation
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

5

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
Items | Subject
Device | Predicate Device | | | | Remark | |
|------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------|--------------|
| Device Name
and Model | Digital TENS
Unit | Electronic
Pulse
Stimulator | Electronic
Pulse
Stimulator,
Model:MDTS1
00 | Tyece
TENS
Model SEM44 | OTC IQ
Device, Technologies | -- | |
| 510(k)
Number | Applying | K141260 | K160508 | K150386 | K131290 | -- | |
| 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. | 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. | The Electronic
Pulse
Stimulator
MDTS100 is
to be used for
temporary
relief of pain
associated
with sore and
aching
muscles in the
shoulder,
waist, back,
upper
extremities
(arm), and
lower
extremities
(leg) due to
strain from
exercise or
normal
household
activities. | The Tyece OTC
TENS Device,
Model SEM44
is to be used for
temporary relief
of pain
associated with
sore and aching
muscles in the
lower back,
arms, or legs
due to strain
from exercise or
normal
household
activities. | TENS:
To be used for
temporary
relief of pain
associated with
sore and aching
muscles in the
shoulder, waist,
back, upper
extremities
(arm), and SE
lower
extremities
(leg) due to
strain from
exercise or
normal
household
work activities. | -- | |
| Comparison
Items | Subject
Device | Predicate Device | | | | Remark | |
| | | | normal
household and
work
activities. | | PMS:
It is intended to
be used to
stimulate
healthy
muscles in
order to
improve and
facilitate
muscle
performance. | | |
| Basic Unit Specifications | | | | | | | |
| Power
Source(s) | DC 3.7V
Lithium
Battery(rechargeable) | | DC 3V, 2
AAA batteries | 4.5V(batteries,
3x1.5V AM) | DC 3.7V SE
Lithium
Battery(rechargeable) | | |
| Method of
Line Current
Isolation | Not
applicable for
DC current | | Not applicable
for DC current | Not applicable
for DC current | Not applicable SE
for DC current | | |
| Patient
Leakage
Current | -- | | -- | -- | -- | | |
| -Normal
Condition
(μΑ) | 0.7