K942311 is an FDA 510(k) clearance for the DYNASTY U1-33 AGM. This device is classified as a Components, Wheelchair (Class I - General Controls, product code KNN).
Submitted by Foley & Lardner (Washington, US). The FDA issued a Cleared decision on November 7, 1994, 178 days after receiving the submission on May 13, 1994.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.3920.
| 510(k) Number | K942311 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 13, 1994 |
| Decision Date | November 07, 1994 |
| Days to Decision | 178 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | Statement |
| Product Code | KNN — Components, Wheelchair |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 890.3920 |