# K253896: TENS/EMS device (GUSE01)

- Pathway: 510(k) (Traditional)
- Applicant: Globalcare Medical Technology Co., Ltd.
- Decided: Mar 4, 2026 after 89 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). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171803: HIVOX OTC Electrical Stimulator, Hivox Biotek, Inc. (2017) Summary page 5.

## Indications for use
TENS: The device is designed to be used for temporary relief of pain associated with sore and aching muscles due to strain from exercise or normal household and work activities EMS: The device is designed to be used for stimulating healthy muscles in order to improve and facilitate muscle performance.

Source page: https://510kreport.com/device/K253896
Methodology: https://510kreport.com/methodology