K830784 is an FDA 510(k) clearance for the WALK N ROLL. This device is classified as a Walker, Mechanical (Class I - General Controls, product code ITJ).
Submitted by Meta-Morris (Mchenry, US). The FDA issued a Cleared decision on May 25, 1983, 75 days after receiving the submission on March 11, 1983.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.3825.
| 510(k) Number | K830784 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 11, 1983 |
| Decision Date | May 25, 1983 |
| Days to Decision | 75 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 |