K844368 is an FDA 510(k) clearance for the LINEAR LIFT DEVICE. This device is classified as a System, Isokinetic Testing And Evaluation (Class II - Special Controls, product code IKK).
Submitted by Cybex (Ronkonkoma, US). The FDA issued a Cleared decision on February 19, 1985, 98 days after receiving the submission on November 13, 1984.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.1925.
| 510(k) Number | K844368 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 13, 1984 |
| Decision Date | February 19, 1985 |
| Days to Decision | 98 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | — |
| Product Code | IKK — System, Isokinetic Testing And Evaluation |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 890.1925 |