Device Classification Name |
stimulator, muscle, powered, for muscle conditioning
|
510(k) Number |
K142055 |
Device Name |
GYMFORM ABS & CORE |
Applicant |
WELL BRAIN INTERNATIONAL, LTD. |
ROOM 03, 14/F, FOOK YIP BLG., 53-57 |
KWAI FUNG CRESCENT |
KWAI CHUNG, N.T.,
HK
|
|
Applicant Contact |
VICTOR K WAI |
Correspondent |
WELL BRAIN INTERNATIONAL, LTD. |
ROOM 03, 14/F, FOOK YIP BLDG., 53-57 |
KWAI FUNG CRESCENT |
CHUNG, N.T.,
HK
|
|
Correspondent Contact |
VICTOR K WAI |
Regulation Number | 890.5850
|
Classification Product Code |
|
Date Received | 07/29/2014 |
Decision Date | 05/11/2015 |
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
|
|
|