Device Classification Name |
Stimulator, Muscle, Powered, For Muscle Conditioning
|
510(k) Number |
K202148 |
Device Name |
E-Fit Infinity System (EF-2090 Controller and EF-100 Unit) |
Applicant |
Fit-Pro Ltd. |
7 Szabadsag Ter |
Budapest,
HU
1054
|
|
Applicant Contact |
Janos Papp |
Correspondent |
Fit-Pro Ltd. |
7 Szabadsag Ter |
Budapest,
HU
1054
|
|
Correspondent Contact |
Janos Papp |
Regulation Number | 890.5850
|
Classification Product Code |
|
Date Received | 08/03/2020 |
Decision Date | 08/25/2021 |
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
|
|
|