Device Classification Name |
Stimulator, Muscle, Powered, For Muscle Conditioning
|
510(k) Number |
K212413 |
Device Name |
I-Motion |
Applicant |
I-Motion Group Global Iberica S.L. |
Calle Loeches 66.8 CP |
Alcorcon,
ES
28925
|
|
Applicant Contact |
Jose Luis Soto Belloso |
Correspondent |
I-Motion Group Global Iberica S.L. |
Calle Loeches 66.8 CP |
Alcorcon,
ES
28925
|
|
Correspondent Contact |
Jose Luis Soto Belloso |
Regulation Number | 890.5850
|
Classification Product Code |
|
Date Received | 08/03/2021 |
Decision Date | 05/26/2022 |
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
|
|
|