K823882 is an FDA 510(k) clearance for the M-BRACE. This device is classified as a Orthosis, Lumbo-sacral (Class I — General Controls, product code IPY).
Submitted by Buckman Consultants (Mchenry, US). The FDA issued a Cleared decision on January 17, 1983, 21 days after receiving the submission on December 27, 1982.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.3490.
| 510(k) Number | K823882 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 27, 1982 |
| Decision Date | January 17, 1983 |
| Days to Decision | 21 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 |