AD-2126 Transcutaneous Electrical Nerve Stimulators (TENS)
510(k) K222867
Active
Valid until
Not listed
FDA recalls
None foundTrust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE 510(k) | NumberK222867 | Date21 Dec 2022 | StatusActive |
| European Union | CE/MDR EUDAMED | Number— | Date— | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- 510(k) Number
- FDA Product Code
- NUH
- FDA applicant
- Andon Health Co, Ltd.
- Device Class
- Class II
- Regulation
- 21 CFR Part 882.5890
- Advisory Committee
- Neurology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 18 Sep 2026
The AD-2126 is a transcutaneous electrical nerve stimulator (TENS), a device designed to deliver low-voltage electrical currents through electrodes placed on the skin to modulate pain perception. It operates by stimulating peripheral nerves to interfere with pain signals, providing non-invasive pain relief for conditions such as chronic pain, muscle soreness, or postoperative discomfort. The device falls under the category of neuromodulation devices, targeting nerve pathways to alleviate symptoms without pharmacological intervention.
The AD-2126 is supplied as a reusable medical device, intended for use in clinical and home settings by trained personnel or patients under supervision. It is not sterile and requires proper cleaning and maintenance between uses to ensure hygiene and functionality. The device is classified under product code NUH (Neurology) and has received FDA 510(k) clearance as substantially equivalent to a predicate device, alongside compliance with the EU Medical Device Regulation (MDR). Storage conditions include protection from moisture and extreme temperatures, and it must be used in accordance with manufacturer instructions to maintain performance and safety.
Other devices from Andon Health Co., Ltd.
Questions
AI-generated answers, 18 Sep 2026
Is the AD-2126 TENS device meant for single-use or can it be reused in a clinical setting?
The AD-2126 is designed as a reusable medical device, intended for use in both clinical and home settings. Since it is not sterile, proper cleaning and maintenance between uses are required to ensure hygiene and functionality, as outlined in the manufacturer’s instructions.
What types of pain conditions is the AD-2126 TENS device intended to help with?
The AD-2126 is designed to provide non-invasive pain relief for conditions like chronic pain, muscle soreness, and postoperative discomfort by delivering low-voltage electrical currents to modulate pain perception through nerve stimulation.
How should the AD-2126 TENS device be stored to maintain its performance?
The device must be stored in a dry environment, protected from moisture and extreme temperatures. Adherence to the manufacturer’s instructions ensures optimal performance and safety, as specified in the device documentation.
What regulatory pathways has the AD-2126 TENS device followed for approval?
The AD-2126 has received FDA 510(k) clearance as substantially equivalent to a predicate device and complies with the EU Medical Device Regulation (MDR). It was classified under product code NUH (Neurology) and reviewed by the Neurology (NE) advisory committee.