The following data is part of a premarket notification filed by Ne Services Ltd. with the FDA for Kegel8 Pelvic Exerciser, Model Oph 400.
| Device ID | K081480 |
| 510k Number | K081480 |
| Device Name: | KEGEL8 PELVIC EXERCISER, MODEL OPH 400 |
| Classification | Stimulator, Electrical, Non-implantable, For Incontinence |
| Applicant | NE SERVICES LTD. 4663 KATE LANE Oxford, OH 45056 |
| Contact | Brent Reider |
| Correspondent | Brent Reider NE SERVICES LTD. 4663 KATE LANE Oxford, OH 45056 |
| Product Code | KPI |
| CFR Regulation Number | 876.5320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-05-27 |
| Decision Date | 2008-09-12 |
| Summary: | summary |