The following data is part of a premarket notification filed by Theragun, Inc. with the FDA for Theraface Microcurrent.
| Device ID | K212238 |
| 510k Number | K212238 |
| Device Name: | TheraFace Microcurrent |
| Classification | Stimulator, Transcutaneous Electrical, Aesthetic Purposes |
| Applicant | Theragun, Inc. 6100 Wilshire Blvd, Suite 200 Los Angeles, CA 90048 |
| Contact | Jaime Sanchez |
| Correspondent | Thomas Padula Schiff & Company, Inc. 583 Mountain Avenue North Caldwell, NJ 07006 |
| Product Code | NFO |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-07-19 |
| Decision Date | 2021-09-29 |