K802603 is an FDA 510(k) clearance for the ECONO-FLOAT WHEELCHAIR FLOTATION CUSHION. This device is classified as a Restraint, Wheelchair, Non-protective (Class I - General Controls, product code KID).
Submitted by Jefferson Industries, Inc. (Mchenry, US). The FDA issued a Cleared decision on November 12, 1980, 22 days after receiving the submission on October 21, 1980.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.3910.
| 510(k) Number | K802603 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 21, 1980 |
| Decision Date | November 12, 1980 |
| Days to Decision | 22 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | — |
| Product Code | KID — Restraint, Wheelchair, Non-protective |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 890.3910 |