K820591 is an FDA 510(k) clearance for the MECHANICAL CHAIR. This device is classified as a Stroller, Adaptive (Class I - General Controls, product code LBE).
Submitted by Kaye Products, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 15, 1982, 11 days after receiving the submission on March 4, 1982.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.3850.
| 510(k) Number | K820591 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 04, 1982 |
| Decision Date | March 15, 1982 |
| Days to Decision | 11 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | — |
| Product Code | LBE — Stroller, Adaptive |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 890.3850 |