Device Classification Name |
Stimulator, Electrical, Non-Implantable, For Incontinence
More FDA Info for this Device |
510(K) Number |
K213133 |
Device Name |
Stimulator, Electrical, Non-Implantable, For Incontinence |
Applicant |
Oriental Inspiration Limited
Unit D (01), 14/F.,Block 1,Tai Ping Industrial Centre,
No. 57 Ting Kok Road, Tai Po, New Territories
Hong Kong CN
Other 510(k) Applications for this Company
|
Contact |
Francis Ko
Other 510(k) Applications for this Contact |
Regulation Number |
876.5320
More FDA Info for this Regulation Number |
Classification Product Code |
KPI
Other 510(k) Applications for this Device
More FDA Info for this Product Code |
Date Received |
09/27/2021 |
Decision Date |
04/13/2022 |
Decision |
SESE - SUBST EQUIV |
Classification Advisory Committee |
GU - Gastroenterology & Urology |
Review Advisory Committee |
GU - Gastroenterology & Urology |
Statement / Summary / Purged Status |
Statement |
Type |
Traditional |
Reviewed By Third Party |
N |
Expedited Review |
|