# K183288: Transcutaneous Electrical Nerve Stimulator

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Kentro Medical Electronics Co., Ltd.
- Decided: Jul 30, 2019 after 246 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 K940301 (1994). 9 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

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

## Most influential descendants
- K200237: Transcutaneous Electronic Nerve Stimulator (2020), 0 descendants of its own

## Indications for use
To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, back, arm, leg, foot, due to strain from exercise or normal household and work activities.

Source page: https://510kreport.com/device/K183288
Methodology: https://510kreport.com/methodology