# K150043: Transcutaneous Electrical Nerve Stimulators (TENS)

- Pathway: 510(k) (Traditional)
- Applicant: Andon Health Co, Ltd.
- Decided: Aug 14, 2015 after 217 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: 5 generations back to K881114 (1988). 16 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131159: Smartrelief, Chattem, Inc. (2013) Summary page 4.
- K140168: Easystim TN28_Otc, Easymed Instruments Co., Ltd. (2014) Summary page 4.

## Most influential descendants
- K222867: AD-2126 Transcutaneous Electrical Nerve Stimulators (TENS) (2022), 0 descendants of its own

## Indications for use
The AD-2129A 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/K150043
Methodology: https://510kreport.com/methodology