# K212377: Transcutaneous Electrical Applicator (TEA), Model SNM-FDC01

- Pathway: 510(k) (Traditional)
- Applicant: Ningbo Medkinetic Medical Device Co., Ltd.
- Decided: Apr 15, 2022 after 256 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.
1 later device descends from it; 1 cites it directly.
0 of 2 devices 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.

## Most influential descendants
- K243613: Patch-TEA (Model TRI-21) (2025), 0 descendants of its own

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

Source page: https://510kreport.com/device/K212377
Methodology: https://510kreport.com/methodology