Device Classification Name |
Stimulator, Nerve, Transcutaneous, For Pain Relief
More FDA Info for this Device |
510(K) Number |
K120569 |
Device Name |
Stimulator, Nerve, Transcutaneous, For Pain Relief |
Applicant |
GEMORE TECHNOLOGY CO., LTD.
11 FL, NO. 29-5, SEC. 2
CHUNG CHENG E. RD.
TAN SHUI, TAIPEI HSIEN 251 TW
Other 510(k) Applications for this Company
|
Contact |
BODEN S.P. LAI
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 |
02/27/2012 |
Decision Date |
07/20/2012 |
Decision |
SESE - SUBST EQUIV |
Classification Advisory Committee |
NE - Neurology |
Review Advisory Committee |
NE - Neurology |
Statement / Summary / Purged Status |
Summary |
Type |
Abbreviated |
Reviewed By Third Party |
N |
Expedited Review |
|