Device Classification Name |
Stimulator, Muscle, Powered, For Muscle Conditioning
More FDA Info for this Device |
510(K) Number |
K181728 |
Device Name |
Stimulator, Muscle, Powered, For Muscle Conditioning |
Applicant |
Shenzhen Kentro Medical Electronics Co., Ltd
No.3, Xihu Industry Zone, Xikeng Village, Henggang Town,
Longgang District
Shenzhen 518115 CN
Other 510(k) Applications for this Company
|
Contact |
Zewu Zhang
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 |
06/29/2018 |
Decision Date |
10/17/2018 |
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 |
|