Device Classification Name |
Stimulator, Nerve, Transcutaneous, Over-The-Counter
More FDA Info for this Device |
510(K) Number |
K230829 |
Device Name |
Stimulator, Nerve, Transcutaneous, Over-The-Counter |
Applicant |
Chongqing Rob Linka Science And Technology Co., Ltd.
B3-2, Liangjiang Health Science And Technology City,
No. 2 Yuekang Road, Fuxing Street, Beibei D
Chongqing 400700 CN
Other 510(k) Applications for this Company
|
Contact |
Yixuan Li
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 |
03/27/2023 |
Decision Date |
04/26/2023 |
Decision |
SESE - SUBST EQUIV |
Classification Advisory Committee |
NE - Neurology |
Review Advisory Committee |
NE - Neurology |
Statement / Summary / Purged Status |
Statement |
Type |
Traditional |
Reviewed By Third Party |
Y |
Expedited Review |
|