Device Classification Name |
Stimulator, Muscle, Powered, For Muscle Conditioning
More FDA Info for this Device |
510(K) Number |
K130074 |
Device Name |
Stimulator, Muscle, Powered, For Muscle Conditioning |
Applicant |
WELL BRAIN INTERNATIONAL, LTD.
RM.1212, 12 FL, HARBOUR CRYSTAL CENTRE, NO. 100 GRANVILLE RD
HONG KONG 999077 CN
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 |
01/14/2013 |
Decision Date |
08/15/2013 |
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 |
|