Device Classification Name |
Stimulator, Nerve, Transcutaneous, For Pain Relief
More FDA Info for this Device |
510(K) Number |
K162663 |
Device Name |
Stimulator, Nerve, Transcutaneous, For Pain Relief |
Applicant |
WELL-LIFE HEALTHCARE LIMITED
1F, NO. 16, LANE 454, JUNGJENG ROAD
YUNGHE DISTRICT, NEW TAIPEI CITY 234 TW
Other 510(k) Applications for this Company
|
Contact |
CHIN-CHIH HSIEH
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 |
09/26/2016 |
Decision Date |
01/17/2017 |
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 |
|