# K230174: TENS and EMS Stimulation (OTC)

- Pathway: 510(k) (Traditional)
- Applicant: Changsha Yuwen Medical Equipment Co., Ltd.
- Decided: Mar 20, 2023 after 59 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
TENS: To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm), lower extremities (leg), abdomen and bottom due to strain from exercise or normal household work activities. EMS: To be used for stimulation healthy muscles in order to improve or facilitate muscle performance.

Source page: https://510kreport.com/device/K230174
Methodology: https://510kreport.com/methodology