Transcutaneous Electrical Nerve Stimulators (TENS)

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

No FDA recalls found in the data synced 22 Oct 2026.

Trade Name

Tens

Model / Reference

AD-2126, /

FDA applicant

Andon Health Co, Ltd.

Primary DI / UDI-DI

16930251800993

Basic UDI-DI

B-16930251800993

510(k) Number

K150043 ↗

FDA Product Code

NUH

EMDN Code

Z12101106 Neurological stimulators

Device Class

Class IIa EUDAMED

Class II 510(k)

Regulation

21 CFR Part 882.5890

EU market of registration

Poland

Advisory Committee

Neurology

FDA Decision

SESE Substantially Equivalent

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See all devices from Andon Health Co., Ltd. →

• What types of pain is this TENS device designed to manage, and how does it work to provide relief?

  This TENS device is specifically designed to manage muscular pain by delivering low-voltage electrical currents through adhesive electrodes placed on the skin. It works by modulating nerve signals, which helps interrupt pain signals traveling to the brain, providing relief for muscle-related discomfort. It is not intended for other types of pain (e.g., neuropathic or visceral pain) or acute trauma.

• Is the TENS unit reusable, and if so, how should it be maintained to ensure proper function?

  Yes, the TENS unit itself is reusable, while the electrodes are disposable. To maintain proper function, follow standard electrical medical device protocols, including regular cleaning of the reusable unit with a mild disinfectant (if applicable) and ensuring electrodes are replaced after each use. Avoid submerging the unit in water or exposing it to extreme temperatures.

• What storage conditions should be followed for the TENS device and its disposable electrodes?

  The TENS unit and its disposable electrodes should be stored in a dry, clean environment away from direct sunlight, extreme heat, or moisture. The reusable unit should be kept in its original packaging or a protective case when not in use, while disposable electrodes should be stored in their sealed packaging until ready for application to maintain sterility.

• Are there different models or sizes available for this TENS device, and how would I determine which one is best for my needs?

  The provided data does not specify multiple models or sizes for this TENS device, so it appears to be a single-unit design with interchangeable adhesive electrodes. The choice of electrode placement (e.g., size and location) depends on the targeted pain area, but the device itself does not offer variable intensity or waveform settings beyond what is standard for TENS units. Always consult clinical guidelines or a healthcare provider for proper electrode application.