# K212238: TheraFace Microcurrent

- Pathway: 510(k) (Traditional)
- Applicant: Theragun, Inc.
- Decided: Sep 29, 2021 after 72 days
- Product code: NFO (Stimulator, Transcutaneous Electrical, Aesthetic Purposes)
- 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: 15 generations back to K943450 (1995). 154 ancestors in all.
No later device cites it as a predicate yet.
0 of 155 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171821: 2 Face / Face Evolution, Heat IN A Click (2018) Summary page 4.

## Indications for use
The TheraFace microcurrent is a hand-held device for over-the-counter aesthetic purposes. The TheraFace microcurrent is indicated for facial stimulation.

Source page: https://510kreport.com/device/K212238
Methodology: https://510kreport.com/methodology