Device Classification Name |
Stimulator, Transcutaneous Electrical, Aesthetic Purposes
|
510(k) Number |
K200803 |
Device Name |
BEAR and BEAR mini |
Applicant |
FOREO, Inc. |
1525 E. Pama Lane |
Las Vegas,
NV
89119
|
|
Applicant Contact |
Laura HoShue |
Correspondent |
FOREO, Inc. |
1525 E. Pama Lane |
Las Vegas,
NV
89119
|
|
Correspondent Contact |
Laura HoShue |
Regulation Number | 882.5890
|
Classification Product Code |
|
Date Received | 03/27/2020 |
Decision Date | 07/31/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|