K Number
K213835
Device Name
TENS & EMS Device
Date Cleared
2022-03-03

(84 days)

Product Code
Regulation Number
882.5890
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
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 Description
The device of the model TU3424-F 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.
More Information

No
The description focuses on standard TENS/EMS functionality with pre-programmed modes and adjustable intensity, and there is no mention of AI or ML in the device description, intended use, or performance studies.

Yes
Explanation: The device is described as a Transcutaneous Electrical Nerve Stimulator (TENS) and Powered Muscle Stimulator (EMS), which are both types of therapeutic devices used for pain relief and muscle performance improvement.

No

The device is described as providing temporary relief of pain (TENS) and stimulating muscles to improve performance (EMS), not to diagnose a condition.

No

The device description explicitly states it is a "portable, battery powered (lithium battery 3.7V DC) multifunction device" that transmits electrical pulses through electrode pads, indicating it is a hardware device with embedded software, not a software-only medical device.

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

Here's why:

  • Intended Use: The intended use clearly states the device is for temporary relief of pain and muscle stimulation. These are therapeutic applications, not diagnostic ones.
  • Device Description: The description details a device that delivers electrical pulses to the body through electrodes. This is consistent with TENS and EMS devices, which are used for physical therapy and pain management.
  • Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing information about a patient's health status based on such analysis. IVD devices are specifically designed for these purposes.

In summary, the device's function and intended use are entirely focused on delivering electrical stimulation for therapeutic benefits, not on diagnosing any condition.

N/A

Intended Use / Indications 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 (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.

Product codes

NUH, NGX

Device Description

The device of the model TU3424-F 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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

shoulder, waist, back, neck, upper extremities (arm), lower extremities (leg), abdomen and bottom

Indicated Patient Age Range

≥ 18 years

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)

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. 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.

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

Not Found

Predicate Device(s)

K202866

Reference Device(s)

K092546

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 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).

0

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March 3, 2022

Shenzhen Jian feng Electronic Technology Co. Ltd. Feng Wen GM 902,903 Jialingyu Industrial Building, Da Pu Road Houting Village, Shajing Town, Baoan District Shenzhen, Guangdong 518104 China

Re: K213835

Trade/Device Name: TENS & EMS Device Regulation Number: 21 CFR 882.5890; 21 CFR 890.5850 Regulation Name: Transcutaneous Electrical Nerve Stimulator For Pain Relief: Powered muscle stimulator Regulatory Class: Class II Product Code: NUH, NGX Dated: December 9, 2021 Received: December 9, 2021

Dear Feng Wen:

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.

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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 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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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) K213835

Device Name TENS & 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

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

Type of 510(k) submission: Traditional

Date of the summary prepared: Jan-30-2022

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: wenfeng@fzjhealth.com

Tel: +86-755-33858361 Fax: +86-755-33858360

Application Correspondent

Company: 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: Fenq Wen

Title: General Manager

Email: wenfeng@fzjhealth.com

Tel: +86-755-33858361 Fax: +86-755-33858360

The Predicate Device Information

Basic InformationPredicate Device
ManufacturerShenzhen Jian Feng Electronic Technology Co., Ltd.
Device NameTENS & EMS Device
ModelFM-B2403
510(K) NumberK202866
Product CodeNUH, NGX
Panel CodePhysical Medicine, Neurology
Regulation Number21 CFR 882.5890
21 CFR 890.5850
Regulation ClassClass II

Subject Device Information

Trade Name: TENS & EMS Device Common Name: TENS, EMS, Stimulator for pain relief; Classification Name: Transcutaneous electrical nerve stimulator for pain relief; Powered muscle stimulator Review Panel: Physical Medicine; Neurology

4

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

Device Description / Design of Device

The device of the model TU3424-F 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.

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.

Technological characteristics and substantial equivalence The following table is the basic characteristic:

ContentsNew devicePredicate DeviceSE
Trade NameTENS & EMS DeviceTENS & EMS DeviceSE
Device ModelTU3424-FFM-B2403/
510(k) NumberK213835K202866/
ManufacturerShenzhen Jian Feng Electronic
Technology Co., Ltd.Shenzhen Jian Feng Electronic
Technology Co., Ltd.SE
Regulatory Information882.5890, 890.5850882.5890, 890.5850SE
ClassificationClass IIClass IISE
Product codeNUH, NGXNUH, NGXSE

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PanelPhysical Medicine; NeurologyPhysical Medicine; NeurologySE
OTC/RXOTCOTCSE
Intended UseTENS: 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.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.SE
Apply parts of the bodyShoulder, waist, back, neck, upper
extremities (arm), lower extremities
(leg), abdomen and bottomShoulder, waist, back, neck, upper
extremities (arm), lower extremities
(leg), abdomen and bottomSE
Power SourceBuilt-in 3.7V lithium batteryBuilt-in 3.7V lithium batterySE
- Method of Line Current
IsolationBFBFSE
- Patient Leakage Current//
- Normal condition