Device Classification Name |
Stimulator, Muscle, Powered, For Muscle Conditioning
|
510(k) Number |
K202653 |
Device Name |
Gymform Total ABS |
Applicant |
Well Brain International Ltd. |
Room 1403 Fook Yip Building, 53-57 Kwai Fung Crescent, |
Kwai Chung |
Hong Kong,
CN
|
|
Applicant Contact |
Victor K. Wai |
Correspondent |
Guangzhou Kinda Biological Technology Co., Ltd |
6F, No.1 TianTai road, Science City, LuoGang District, |
GuangZhou,
CN
|
|
Correspondent Contact |
Jet Li |
Regulation Number | 890.5850
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 09/14/2020 |
Decision Date | 01/15/2021 |
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
|
|
|