K861632 is an FDA 510(k) clearance for the SIMS CHAIR. This device is classified as a System, Isokinetic Testing And Evaluation (Class II - Special Controls, product code IKK).
Submitted by Twin City Surgical, Inc. (St. Paul, US). The FDA issued a Cleared decision on May 27, 1986, 28 days after receiving the submission on April 29, 1986.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.1925.
| 510(k) Number | K861632 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 29, 1986 |
| Decision Date | May 27, 1986 |
| Days to Decision | 28 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 |