The following data is part of a premarket notification filed by Utah Medical Products, Inc. with the FDA for Liberty Rectal Pelvic Floor Exerciser.
| Device ID | K964526 |
| 510k Number | K964526 |
| Device Name: | LIBERTY RECTAL PELVIC FLOOR EXERCISER |
| Classification | Stimulator, Electrical, Non-implantable, For Incontinence |
| Applicant | UTAH MEDICAL PRODUCTS, INC. 7043 SOUTH 300 WEST Midvale, UT 84047 -1048 |
| Contact | John W Smith |
| Correspondent | John W Smith UTAH MEDICAL PRODUCTS, INC. 7043 SOUTH 300 WEST Midvale, UT 84047 -1048 |
| Product Code | KPI |
| CFR Regulation Number | 876.5320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-11-12 |
| Decision Date | 1997-02-10 |
| Summary: | summary |