The following data is part of a premarket notification filed by Nautilus Sports/medical Industries, Inc. with the FDA for Nautilus Leg Extension Testing & Rehabilitation.
| Device ID | K861206 |
| 510k Number | K861206 |
| Device Name: | NAUTILUS LEG EXTENSION TESTING & REHABILITATION |
| Classification | System, Isokinetic Testing And Evaluation |
| Applicant | NAUTILUS SPORTS/MEDICAL INDUSTRIES, INC. POST OFFICE BOX 1783 Deland, FL 32720 |
| Contact | Organ, M.d. |
| Correspondent | Organ, M.d. NAUTILUS SPORTS/MEDICAL INDUSTRIES, INC. POST OFFICE BOX 1783 Deland, FL 32720 |
| Product Code | IKK |
| CFR Regulation Number | 890.1925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-03-31 |
| Decision Date | 1986-04-18 |