K843739 is an FDA 510(k) clearance for the CYBEX TORSO TESTING & REHABILITATION. 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 November 29, 1984, 65 days after receiving the submission on September 25, 1984.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.1925.
| 510(k) Number | K843739 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 25, 1984 |
| Decision Date | November 29, 1984 |
| Days to Decision | 65 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 |