K823823 is an FDA 510(k) clearance for the LUMBOSACRAL SUPPORT. This device is classified as a Orthosis, Lumbo-sacral (Class I - General Controls, product code IPY).
Submitted by Danek Medical, Inc. (Walker, US). The FDA issued a Cleared decision on January 14, 1983, 28 days after receiving the submission on December 17, 1982.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.3490.
| 510(k) Number | K823823 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 17, 1982 |
| Decision Date | January 14, 1983 |
| Days to Decision | 28 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | — |
| Product Code | IPY — Orthosis, Lumbo-sacral |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 890.3490 |