Device Classification Name |
Stimulator, Nerve, Transcutaneous, Over-The-Counter
More FDA Info for this Device |
510(K) Number |
K203574 |
Device Name |
Stimulator, Nerve, Transcutaneous, Over-The-Counter |
Applicant |
Hivox Biotek Inc.
SF, No. 123, Xingde Road, Sanchong District,
New Taipei City 241 TW
Other 510(k) Applications for this Company
|
Contact |
Ruby Lu
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 |
12/07/2020 |
Decision Date |
03/10/2021 |
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 |
|