# K222867: AD-2126 Transcutaneous Electrical Nerve Stimulators (TENS)

- Pathway: 510(k) (Abbreviated)
- Applicant: Andon Health Co, Ltd.
- Decided: Dec 21, 2022 after 90 days
- Product code: NUH (Stimulator, Nerve, Transcutaneous, Over-The-Counter)
- Device class: 2
- Regulation: 21 CFR 882.5890
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K881114 (1988). 17 ancestors in all.
No later device cites it as a predicate yet.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150043: Transcutaneous Electrical Nerve Stimulators (TENS), Andon Health Co, Ltd. (2015)

## Indications for use
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 and relief of pain associated with arthritis.

Source page: https://510kreport.com/device/K222867
Methodology: https://510kreport.com/methodology