Device Classification Name |
Stimulator, Nerve, Transcutaneous, Over-The-Counter
More FDA Info for this Device |
510(K) Number |
K163166 |
Device Name |
Stimulator, Nerve, Transcutaneous, Over-The-Counter |
Applicant |
EASYWELL BIOMEDICALS, INC.
SUITE 2, 2F, NO.9, JHANYE 1 RD. HSINCHU SCIENCE PARK
Hsinchu TW
Other 510(k) Applications for this Company
|
Contact |
ARTHUR CHEN
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 |
11/14/2016 |
Decision Date |
08/11/2017 |
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 |
|