# K200237: Transcutaneous Electronic Nerve Stimulator

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Kentro Medical Electronics Co., Ltd.
- Decided: Oct 19, 2020 after 269 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: 7 generations back to K940301 (1994). 34 ancestors in all.
No later device cites it as a predicate yet.
0 of 35 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160893: HANAROCare ReJu, M.I.Tech Co., Ltd. (2016) Summary page 5.
- K183288: Transcutaneous Electrical Nerve Stimulator, Shenzhen Kentro Medical Electronics Co., Ltd. (2019) Summary page 5.
- K163611: Pain Therapy Device, Guangzhou Xinbo Electronic Co., Ltd. (2017) Summary page 5.

## Indications for use
Transcutaneous Electronic Nerve Stimulator is indicated for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm) and lower extremities (leg) due to strain from exercise or normal household work activities.

Source page: https://510kreport.com/device/K200237
Methodology: https://510kreport.com/methodology