Device Classification Name |
Stimulator, Muscle, Powered, For Muscle Conditioning
More FDA Info for this Device |
510(K) Number |
K231136 |
Device Name |
Stimulator, Muscle, Powered, For Muscle Conditioning |
Applicant |
Shenzhen KeLuTongDa Industrial Co.,Ltd.
217,44-46 Xintun South Road,Xinlian community,Longcheng
street, Longgang District
Shenzhen 518172 CN
Other 510(k) Applications for this Company
|
Contact |
Zhongliang Luo
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 |
04/21/2023 |
Decision Date |
06/16/2023 |
Decision |
SESE - SUBST EQUIV |
Classification Advisory Committee |
PM - Physical Medicine |
Review Advisory Committee |
PM - Physical Medicine |
Statement / Summary / Purged Status |
Statement |
Type |
Traditional |
Reviewed By Third Party |
N |
Expedited Review |
|