The following data is part of a premarket notification filed by Tenscare Ltd. with the FDA for Perfect Pfe.
| Device ID | K191312 |
| 510k Number | K191312 |
| Device Name: | Perfect PFE |
| Classification | Stimulator, Electrical, Non-implantable, For Incontinence |
| Applicant | TensCare Ltd. 9 Blenheim Road, Longmead Business Park Epsom, GB Kt19 9be |
| Contact | Andrew Brown |
| Correspondent | Andrew Brown TensCare Ltd. 9 Blenheim Road, Longmead Business Park Epsom, GB Kt19 9be |
| Product Code | KPI |
| CFR Regulation Number | 876.5320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-05-15 |
| Decision Date | 2019-11-01 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05033435134458 | K191312 | 000 |