Device Classification Name |
stimulator, muscle, powered, for muscle conditioning
|
510(k) Number |
K232409 |
Device Name |
Electromagnetic Stimulation Systems |
Applicant |
Shanghai Apolo Medical Technology Co., Ltd. |
Building 11, Lane 1566, Nanle Road, Songjiang District |
Shanghai,
CN
201613
|
|
Applicant Contact |
Felix Li |
Correspondent |
Shanghai Apolo Medical Technology Co., Ltd. |
Building 11, Lane 1566, Nanle Road, Songjiang District |
Shanghai,
CN
201613
|
|
Correspondent Contact |
Felix Li |
Regulation Number | 890.5850
|
Classification Product Code |
|
Date Received | 08/10/2023 |
Decision Date | 04/10/2024 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Physical Medicine
|
510k Review Panel |
Physical Medicine
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|