The following data is part of a premarket notification filed by Myo/kinetic Systems, Inc. with the FDA for Te-800 Pelvic Floor Exerciser.
| Device ID | K945937 |
| 510k Number | K945937 |
| Device Name: | TE-800 PELVIC FLOOR EXERCISER |
| Classification | Perineometer |
| Applicant | MYO/KINETIC SYSTEMS, INC. N. 84 W. 13562 LEON RD. Menomonee Falls, WI 53051 |
| Contact | Gregory L Johnson |
| Correspondent | Gregory L Johnson MYO/KINETIC SYSTEMS, INC. N. 84 W. 13562 LEON RD. Menomonee Falls, WI 53051 |
| Product Code | HIR |
| CFR Regulation Number | 884.1425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-12-05 |
| Decision Date | 1995-07-14 |