Device Classification Name |
Stimulator, Nerve, Transcutaneous, Over-The-Counter
More FDA Info for this Device |
510(K) Number |
K222870 |
Device Name |
Stimulator, Nerve, Transcutaneous, Over-The-Counter |
Applicant |
Shenzhen Kentro Medical Electronics Co., Ltd
2nd Floor No 11, Shanzhuang Road, Xikeng Village,
Yuanshan Street, Longgang District
Shenzhen 518100 CN
Other 510(k) Applications for this Company
|
Contact |
Zewu Zhang
Other 510(k) Applications for this Contact |
Regulation Number |
882.5890
More FDA Info for this Regulation Number |
Classification Product Code |
NUH
Other 510(k) Applications for this Device
More FDA Info for this Product Code |
Date Received |
09/22/2022 |
Decision Date |
05/10/2023 |
Decision |
SESE - SUBST EQUIV |
Classification Advisory Committee |
NE - Neurology |
Review Advisory Committee |
NE - Neurology |
Statement / Summary / Purged Status |
Summary |
Type |
Traditional |
Reviewed By Third Party |
N |
Expedited Review |
|