The following data is part of a premarket notification filed by Hollister, Inc. with the FDA for Incare Pelvic Floor Therapy System With Desktop Computer.
| Device ID | K974048 |
| 510k Number | K974048 |
| Device Name: | INCARE PELVIC FLOOR THERAPY SYSTEM WITH DESKTOP COMPUTER |
| Classification | Stimulator, Electrical, Non-implantable, For Incontinence |
| Applicant | HOLLISTER, INC. 2000 HOLLISTER DR. Libertyville, IL 60048 |
| Contact | Joseph S Tokarz |
| Correspondent | Joseph S Tokarz HOLLISTER, INC. 2000 HOLLISTER DR. Libertyville, IL 60048 |
| Product Code | KPI |
| CFR Regulation Number | 876.5320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-10-24 |
| Decision Date | 1997-12-23 |
| Summary: | summary |