Device Classification Name |
Stimulator, Nerve, Transcutaneous, For Pain Relief
More FDA Info for this Device |
510(K) Number |
K092448 |
Device Name |
Stimulator, Nerve, Transcutaneous, For Pain Relief |
Applicant |
HIVOX BIOTEK, INC.
8 F.,NO. 98, SHINDE RD.,
SANCHONG CITY
TAIPEI HSIEN 24158 TW
Other 510(k) Applications for this Company
|
Contact |
Ke-Min Jen
Other 510(k) Applications for this Contact |
Regulation Number |
882.5890
More FDA Info for this Regulation Number |
Classification Product Code |
GZJ
Other 510(k) Applications for this Device
More FDA Info for this Product Code |
Date Received |
08/10/2009 |
Decision Date |
03/30/2010 |
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 |
|