Device Classification Name |
stimulator, transcutaneous electrical, aesthetic purposes
|
510(k) Number |
K212238 |
Device Name |
TheraFace Microcurrent |
Applicant |
Theragun, Inc. |
6100 Wilshire Blvd, Suite 200 |
Los Angeles,
CA
90048
|
|
Applicant Contact |
Jaime Sanchez |
Correspondent |
Schiff & Company, Inc. |
583 Mountain Avenue |
North Caldwell,
NJ
07006
|
|
Correspondent Contact |
Thomas Padula |
Regulation Number | 882.5890
|
Classification Product Code |
|
Date Received | 07/19/2021 |
Decision Date | 09/29/2021 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|