The following data is part of a premarket notification filed by Metronic, Inc. with the FDA for Medtronic(r) Orthoflex(tm).
| Device ID | K874884 |
| 510k Number | K874884 |
| Device Name: | MEDTRONIC(R) ORTHOFLEX(TM) |
| Classification | Exerciser, Powered |
| Applicant | METRONIC, INC. 7000 CENTRAL AVENUE, N.E. Minneapolis, MN 55432 |
| Contact | David H Mueller |
| Correspondent | David H Mueller METRONIC, INC. 7000 CENTRAL AVENUE, N.E. Minneapolis, MN 55432 |
| Product Code | BXB |
| CFR Regulation Number | 890.5380 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-12-01 |
| Decision Date | 1988-01-28 |