K811489 is an FDA 510(k) clearance for the SCOOTER BOARD. This device is classified as a Board, Scooter, Prone (Class I - General Controls, product code KNL).
Submitted by Fred Sammons, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 12, 1981, 17 days after receiving the submission on May 26, 1981.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5370.
| 510(k) Number | K811489 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 26, 1981 |
| Decision Date | June 12, 1981 |
| Days to Decision | 17 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 |