Device Classification Name |
Stimulator, Muscle, Powered, For Muscle Conditioning
More FDA Info for this Device |
510(K) Number |
K142055 |
Device Name |
Stimulator, Muscle, Powered, For Muscle Conditioning |
Applicant |
WELL BRAIN INTERNATIONAL, LTD.
ROOM 03, 14/F, FOOK YIP BLG., 53-57
KWAI FUNG CRESCENT
KWAI CHUNG, N.T. HK
Other 510(k) Applications for this Company
|
Contact |
VICTOR K WAI
Other 510(k) Applications for this Contact |
Regulation Number |
890.5850
More FDA Info for this Regulation Number |
Classification Product Code |
NGX
Other 510(k) Applications for this Device
More FDA Info for this Product Code |
Date Received |
07/29/2014 |
Decision Date |
05/11/2015 |
Decision |
SESE - SUBST EQUIV |
Classification Advisory Committee |
PM - Physical Medicine |
Review Advisory Committee |
PM - Physical Medicine |
Statement / Summary / Purged Status |
Summary |
Type |
Traditional |
Reviewed By Third Party |
N |
Expedited Review |
|