# K243613: Patch-TEA (Model TRI-21)

- Pathway: 510(k) (Traditional)
- Applicant: Transtimulation Research, Inc.
- Decided: Apr 9, 2025 after 138 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: 10 generations back to K881114 (1988). 53 ancestors in all.
No later device cites it as a predicate yet.
0 of 54 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K212377: Transcutaneous Electrical Applicator (TEA), Model SNM-FDC01, Ningbo Medkinetic Medical Device Co., Ltd. (2022) Summary page 5.
- K231569: ManaFlexx 2 (model: MF002-RX, MF002-OTC), Manamed, Inc. (2023) Summary page 5.

## Indications for use
Patch-TEA is an Over-The-Counter device 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/K243613
Methodology: https://510kreport.com/methodology