K823105 is an FDA 510(k) clearance for the RESI-WALKER. This device is classified as a Walker, Mechanical (Class I - General Controls, product code ITJ).
Submitted by Orthion Corp. (Mchenry, US). The FDA issued a Cleared decision on November 5, 1982, 16 days after receiving the submission on October 20, 1982.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.3825.
| 510(k) Number | K823105 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 20, 1982 |
| Decision Date | November 05, 1982 |
| Days to Decision | 16 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | — |
| Product Code | ITJ — Walker, Mechanical |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 890.3825 |