The following data is part of a premarket notification filed by Neotonus, Inc. with the FDA for Neocontrol Pelvic Floor Therapy System.
| Device ID | K001903 |
| 510k Number | K001903 |
| Device Name: | NEOCONTROL PELVIC FLOOR THERAPY SYSTEM |
| Classification | Stimulator, Electrical, Non-implantable, For Incontinence |
| Applicant | NEOTONUS, INC. 49 PLAIN ST. North Attleboro, MA 02760 |
| Contact | Sheila Hemeon-heyer |
| Correspondent | Sheila Hemeon-heyer NEOTONUS, INC. 49 PLAIN ST. North Attleboro, MA 02760 |
| Product Code | KPI |
| CFR Regulation Number | 876.5320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-06-22 |
| Decision Date | 2000-08-29 |