Device Classification Name |
Stimulator, Muscle, Powered, For Muscle Conditioning
More FDA Info for this Device |
510(K) Number |
K162744 |
Device Name |
Stimulator, Muscle, Powered, For Muscle Conditioning |
Applicant |
EVERYWAY MEDICAL INSTRUMENT CO., LTD.
3FL., NO. 5, LANE 155, SECTION 3,
PEISHEN RD.
SHENKENG DIST, NEW TAIPEI CITY 222 TW
Other 510(k) Applications for this Company
|
Contact |
PAUL HUNG
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 |
09/30/2016 |
Decision Date |
08/03/2017 |
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 |
|