KNL
5 FDA 510(k) clearances · Product code
17 daysmedian time to decision
19 days90th percentile
5clearances measured
FDA profile
- Official device name
- Board, Scooter, Prone
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 890.5370
- Medical specialty
- Physical Medicine
- Flags
- GMP exempt
- Adverse events (MAUDE)
- 1999: 1
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| CRAWLER (K841695) | Maddak, Inc. | 1984-05-10 |
| SCOOTER BOARD (K811489) | Fred Sammons, Inc. | 1981-06-12 |
| THERAPY GYROSCOPE (K790528) | Maddak, Inc. | 1979-04-03 |
| BOARD, SCOOTER (K781198) | Fred Sammons, Inc. | 1978-07-31 |
| THERAPY SCOOTER (K780296) | Convaid Product Development | 1978-02-24 |
Track KNL automatically
Every clearance here is in the API, with alerts when new ones post.