Device Classification Name |
Stimulator, Electrical, Non-Implantable, For Incontinence
|
510(k) Number |
K191312 |
Device Name |
Perfect PFE |
Applicant |
TensCare Ltd. |
9 Blenheim Road, Longmead Business Park |
Epsom,
GB
KT19 9BE
|
|
Applicant Contact |
Andrew Brown |
Correspondent |
TensCare Ltd. |
9 Blenheim Road, Longmead Business Park |
Epsom,
GB
KT19 9BE
|
|
Correspondent Contact |
Andrew Brown |
Regulation Number | 876.5320
|
Classification Product Code |
|
Date Received | 05/15/2019 |
Decision Date | 11/01/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|