Device Classification Name |
stimulator, muscle, powered, for muscle conditioning
|
510(k) Number |
K212866 |
Device Name |
truSculpt flex |
Applicant |
Johari Digital Healthcare Limited |
G-582, 584 EPIP, Boranda |
Jodhpur,
IN
342012
|
|
Applicant Contact |
Pooja Johari |
Correspondent |
Johari Digital Healthcare Limited |
G-582, 584 EPIP, Boranda |
Jodhpur,
IN
342012
|
|
Correspondent Contact |
Pooja Johari |
Regulation Number | 890.5850
|
Classification Product Code |
|
Date Received | 09/08/2021 |
Decision Date | 12/03/2022 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Physical Medicine
|
510k Review Panel |
Physical Medicine
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|