Device Classification Name |
Stimulator, Nerve, Transcutaneous, Over-The-Counter
More FDA Info for this Device |
510(K) Number |
K192087 |
Device Name |
Stimulator, Nerve, Transcutaneous, Over-The-Counter |
Applicant |
Shenzhen Roundwhale Technology Co., Ltd.
202, 2/F, Building 27, Dafa Industrial Park
Longxi Community, Longgang Street
Shenzhen 518108 CN
Other 510(k) Applications for this Company
|
Contact |
Kevin 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 |
08/05/2019 |
Decision Date |
11/01/2019 |
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 |
N |
Expedited Review |
|