The following data is part of a premarket notification filed by Accelerated Care Plus with the FDA for Omnistim Continence+ Pelvic Floor Stimulation System.
| Device ID | K093600 |
| 510k Number | K093600 |
| Device Name: | OMNISTIM CONTINENCE+ PELVIC FLOOR STIMULATION SYSTEM |
| Classification | Stimulator, Electrical, Non-implantable, For Incontinence |
| Applicant | ACCELERATED CARE PLUS 4850 JOULE ST, STE A-1 Reno, NV 89502 |
| Contact | Patrick Parker |
| Correspondent | Jay Y Kogoma INTERTEK TESTING SERVICES 2307 EAST AURORA ROAD UNIT B7 Twinsburg, OH 44087 |
| Product Code | KPI |
| CFR Regulation Number | 876.5320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2009-11-20 |
| Decision Date | 2009-12-04 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00858703006122 | K093600 | 000 |