The AD-2126 Transcutaneous Electrical Nerve Stimulators TENS device is intended for temporary relief of pain associated with sore and aching muscles due to strain from exercise or normal household and work activities, It is also intended for symptomatic relief and management of chronic, intractable pain associated with arthritis.

Device Description

The AD-2126 Transcutaneous Electrical Nerve Stimulators (TENS) is transcutaneous electrical nerve stimulator for relief of muscular pain and sold without prescription.

The device consists of a microprocessor, buttons, electrical pads, and display. Keys can control the device to choose the operation modes, adjust pulse output strength, then the channel that effectively transfers 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 stimulation. The LCD display can show user the mode and strength chosen and other information.

Self-adhesive electrodes are used in this device, and they are designed with conductive adhesive interface between the patient's skin and the Electrical Stimulator which help electrical signals transferred from the TENS device to the body and complete its function. The electrodes to be used with the device have been cleared under submission number K130987 with the trade name of ValuTrode® Neurostimulation Electrodes; model number: 50X50.

AI/ML Overview

This document refers to a 510(k) premarket notification for the AD-2126 Transcutaneous Electrical Nerve Stimulators (TENS). There is no acceptance criteria or study information for an AI/ML device in this document. The document describes non-clinical testing performed to establish substantial equivalence to a predicate TENS device, not an AI/ML device.

Therefore, I cannot provide the requested information.

Summary

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December 21, 2022

Andon Health Co., Ltd. Liu Yi President No. 3 Jinping Street, Ya An Road, Nankai District Tianiin 300190 P.R. China

Re: K222867

Trade/Device Name: AD-2126 Transcutaneous Electrical Nerve Stimulators (TENS) Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator For Pain Relief Regulatory Class: Class II Product Code: NUH, NYN Dated: September 22, 2022 Received: September 22, 2022

Dear Mr. Liu Yi:

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 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

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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 mediation-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).

Sincerelv.

Digitally signed by Robert M. Robert M. Stefani -S Date: 2022.12.21 Stefani -S 11:44:22 -05'00'

For Pamela Scott Assistant Director 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)

Device Name

AD-2126 Transcutaneous Electrical Nerve Stimulators (TENS)

Indications for Use (Describe)

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

(In accordance with 21 CFR 807.92)

1.0 Submitter's Information

Name:	Andon Health Co., Ltd.
Address:	No 3, Jinping Street, Ya An Road, Nankai District, Tianjin, 300190, P.R. China
Phone Number:	86-22-87611660
Fax Number:	86-22-87612379
Contact:	Mr. Liu Yi
Date of Preparation:	September 19, 2022

2.0 Device Information

Device Name:	AD-2126 Transcutaneous Electrical Nerve Stimulators(TENS)
Classification Name:	Stimulator, Nerve, Transcutaneous, Over-The-Counter

3.0 Classification

Product Code:	NUH, NYN
Regulation Number:	21 CFR 882.5890
Classification:	II
Review Panel:	882 Neurology

4.0 Predicate Device Information

Manufacturer:	Andon Health Co., Ltd.
Device:	AD-2126 Transcutaneous Electrical Nerve Stimulators(TENS)
510(k) Number:	K150043
Classification	II
Product Code	NUH, NYN

5.0 Intended Use

The AD-2126 TENS device is intended for temporary relief of pain associated with sore and aching muscles due to strain from exercise or normal household and work activities. It is also intended for symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis.

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6.0 Device Description

The AD-2126 Transcutaneous Electrical Nerve Stimulators (TENS) is transcutaneous electrical nerve stimulator for relief of muscular pain and sold without prescription.

7.0 Discussion of Non-Clinical Testing

TENS conforms to the following standards:

AAMI ANSI ES60601-1:2005/(R)2012 And Al:2012, Cl:2009/(R)2012 And . A2:2010/(R)2012 (Consolidated Text) Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance (IEC 60601-1:2005, MOD)
. IEC 60601-1-11 Edition 2.0 2015-01 Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
IEC 60601-2-10 Edition 2.1 2016-04, Medical electrical equipment Part 2-10: . Particular requirements for the basic safety and essential performance of nerve and muscle stimulators
. IEC 60601-1-2:2014, Medical Electrical Equipment Part 1-2: General Requirements For Basic Safety And Essential Performance -- Collateral Standard: Electromagnetic Disturbances -- Requirements And Tests
ISO 10993: Biological evaluation of medical devices Part 1: Evaluation and . testing within a risk management process.
. ISO 10993: Biological evaluation of medical devices Part 5: Test for in vitro cytotoxicity.

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ISO 10993: Biological evaluation of medical devices Part 10: Test for irritation •

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and skin sensitization.

None of the test demonstrate that the new device raises new questions of safety and effectiveness as compared to the predicate.

8.0 Non-clinical Testing Summary

The following testing was performed on the TENS devices in accordance with the requirements of the design control regulations and established quality assurance procedures.

(1) Biocompatibility of materials

When use the TENS device, one side of the electrode will contact the user, and the materials used on this side is tested according to ISO 10993-5 and ISO 10993-10, and the result shows it meet the applicable requirements.

(2) Electromagnetic Compatibility

Electromagnetic Compatibility test has been performed on the TENS devices according to the identical standard of IEC 60601-1-2, and the test result show that, the device meets all the applicable requirements.

(3) Electrical Safety Testing

Electrical Safety Test has been performed according to AAMI ANSI ES60601-1, and the test result shows that, the device meets all the applicable requirements. Also, particular safety test has been performed according to IEC 60601-2-10.

9.0 Comparison to the Predicate Device and Conclusion

The conclusion drawn from the nonclinical tests demonstrate that the subject device AD-2126 Transcutaneous Electrical Nerve Stimulators is substantially equivalent to theAD-2129A Transcutaneous Electrical Nerve Stimulators (K150043).

Characteristics	Subject device	Predicate device	Comparison
Product name	AD-2126 TENS device	AD-2129A TENS device
510(K)number	To be assigned	K150043
Product code	NUH,NYN	NUH,NYN	Same
Regulation No.	21 CFR 882.5890	21 CFR 882.5890	Same
Intended use	The device is intendedfortemporary relief of painassociated with sore and achingmuscles due to strain fromexercise or normal household	The device is intendedfortemporary relief of painassociated with sore and achingmuscles due to strain fromexercise or normal household	Same
	and work activities, It is alsointended for symptomatic reliefand management of chronic,intractable pain and relief ofpain associated with arthritis.	and work activities, It is alsointended for symptomatic reliefand management of chronic,intractable pain and relief ofpain associated with arthritis.
Presentation orOTC	OTC	OTC	Same
Environment ofuse	Home use	Home use	Same
Number ofOutputs mode	24	8	See 3.3Note 1
Number ofOutputs	2	2	Same
Waveform	Biphasic rectangularMonophasic rectangular	Asymmetrical Biphasicrectangular	See 3.5Note2
Maximum outputvoltage(max)$500\Omega$ , 2 k $\Omega$ , and10 k $\Omega$	$500 \Omega$ : 60V$2K \Omega$ :64.8V$10K \Omega$ : 68.4V	$500 \Omega$ : 48V$2K \Omega$ : 91.2V$10 k \Omega$ : 46V	See 3.6Note 3
MaximumOutputCurrent$500\Omega$ , 2 k $\Omega$ , and10 k $\Omega$	$500\Omega$ : 120mA$2K \Omega$ : 32.4mA$10K \Omega$ : 6.84mA	$500 \Omega$ : 96mA$2K \Omega$ : 4.33mA$10 k \Omega$ :0.44 mA	See 3.6Note3
Maximum PhaseCharge, ( $\mu$ C) @$500\Omega$	12uC	13.82uC	See 3.6Note3
Maximum AverageCurrent( $500\Omega$ )	8.49mA	1.0mA	See 3.6Note 3
Maximum CurrentDensity, (mA/cm²@ $500\Omega$ )	0.34mA/cm²	0.39mA/cm²	See 3.6Note 3
Maximum AveragePower Density,(W/cm²@ $500\Omega$ )	1.44mW/cm²	1.66mW/cm²	See 3.6Note 3
Frequency (Hz)	1-100Hz	2-125HZ	See 3.6Note 3
PulseDuration(us)	1-100	60-120	See 3.6Note 3
Burst Mode	None	None	Same
Timerrange(min)	15~30 minutes can be set forall programs(The default valueis 15 minutes)	15 minutes for all programs	See 3.8Note4
Indicationdisplay:	-On/Off status-Low battery	-On/Off status-Output strength	See 3.9Note 5
	-Voltage/Current level-Output mode-Time to cut-off	-Output mode-Time to cut-off
Power Source	4x 1.5 size AAA	4x1.5 size AAA	Same
Dimension	120.3mmx60.3mmx20.6mm	140mmx63mmx30mm	See 3.11Note6
Weight	73g (exclude battery)	88g (exclude battery)	See 3.11Note6
HousingMaterials	ABS	ABS	Same
Microprocessorcontrol	Yes	Yes	Same
AutomaticOverload trip	No	No	Same
Automaticno-load trip	Yes	Yes	Same
Automaticshut-off	Yes	Yes	Same
User overridecontrol	No	No	Same
Electrodecompliance with21 CFR 898	Yes	Yes	Same
Electrode cable	Yes	Yes	Same

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Note: For the Maximum Average Power Density: Surface area: S=25 cm²; maximum average current output: 1=8.49mA; Load: R=5002; power density: P= IIR/S=0.00144(watts/cm²)

Note 1 The number of output mode of the new device is changed, EMC test, Electrical Safety test and particular safety test have been performed on the new device, and the result show that, the new device is the same safe and effective as the predicate device.
Note 2 The waveform of the new device AD-2126 is different from the predicate device, they all have the Biphasic rectangular waveform. EMC test, Electrical Safety test and particular safety test have been performed on the new device, and the result show that, the new device is the same safe and effective as the predicate device.
Note 3 The output specification are different from the predicate device, such as the Maximum output voltage (at 500Ω, 2 k Ω, and 10 k Ω), the Maximum Output Current (at 500Ω, 2 kΩ, and 10 kΩ), the Maximum Phase Charge(at 500Ω), the Maximum Average Current(at 500Ω), the Maximum Current Density(at 500Ω) and the Maximum Average Power Density(at 500Ω). Moreover, the frequency and time

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duration are also changed. However, the Electrical Safety test and particular safety test can conform that, they are the same safe and effective.

Note 4 15-30 minutes timer range can be set for all programs, which is different from the predicate device, but the software validation can confirm that, the new device is the same safe and effective as the predicate device.
Note 5 The indication display of the new device is the changed, but the software validation can confirm that, the new device is the same safe and effective as the predicate device.

6.Note 6 The dimension and weight are different, because the appearance of the device is changed, however, the Electrical test report and the EMC test report for the new devices can confirm that they are the same safe and effective as the predicate device.

However, the tests in this submission demonstrates that these small differences do not raise any new questions of safety and effectiveness.

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).