# K212184: TENS and EMS Stimulation (OTC)

- Pathway: 510(k) (Traditional)
- Applicant: Changsha Yuwen Medical Equipment Co., Ltd.
- Decided: Apr 1, 2022 after 262 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 mode: It is used for temporary relief of pain associated with sore and aching muscles in the neck, shoulder, back, joint, hip, hand, abdomen, upper extremities (arm) and lower extremities (leg) due to strain from exercise or normal household work activities. EMS mode: This mode is designed to be used for stimulate healthy muscles in order to improve and facilitate muscle performance.

Source page: https://510kreport.com/device/K212184
Methodology: https://510kreport.com/methodology