Device Classification Name |
stimulator, muscle, powered, for muscle conditioning
|
510(k) Number |
K221498 |
Device Name |
Miha Bodytec II |
Applicant |
Miha Bodytec GmbH |
Siemensstr. 1 |
Gersthofen,
DE
86368
|
|
Applicant Contact |
Felix Schweigert |
Correspondent |
Miha Bodytec GmbH |
Siemensstr. 1 |
Gersthofen,
DE
86368
|
|
Correspondent Contact |
Felix Schweigert |
Regulation Number | 890.5850
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 05/23/2022 |
Decision Date | 10/07/2022 |
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
|
|
|