K942260 is an FDA 510(k) clearance for the ALDEN WHEELCHAIR CUSHION. This device is classified as a Components, Wheelchair (Class I - General Controls, product code KNN).
Submitted by Ward and Assoc. (Boulder, US). The FDA issued a Cleared decision on May 26, 1994, 17 days after receiving the submission on May 9, 1994.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.3920.
| 510(k) Number | K942260 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 09, 1994 |
| Decision Date | May 26, 1994 |
| Days to Decision | 17 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 |