K780296 is an FDA 510(k) clearance for the THERAPY SCOOTER. This device is classified as a Board, Scooter, Prone (Class I - General Controls, product code KNL).
Submitted by Convaid Product Development (Mchenry, US). The FDA issued a Cleared decision on February 24, 1978, 3 days after receiving the submission on February 21, 1978.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5370.
| 510(k) Number | K780296 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 21, 1978 |
| Decision Date | February 24, 1978 |
| Days to Decision | 3 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | — |
| Product Code | KNL — Board, Scooter, Prone |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 890.5370 |