FDA product code KNL: Board, Scooter, Prone
KNL is the FDA product code for board, scooter, prone. It is a Class I device, regulated under 21 CFR 890.5370 and reviewed by the Physical Medicine panel. FDA has cleared 5 510(k) submissions under KNL, from 3 different applicants. The average 510(k) review took 15 days (median 17).
Classification
| Field | Value |
|---|---|
| Device name | Board, Scooter, Prone |
| Device class | Class I |
| Regulation | 21 CFR 890.5370 |
| Review panel | PM — Physical Medicine |
| Medical specialty | Physical Medicine |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Top KNL applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Maddak, Inc. | 2 | 1984-05-10 |
| Fred Sammons, Inc. | 2 | 1981-06-12 |
| Convaid Product Development | 1 | 1978-02-24 |
Most recent KNL clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K841695 | Maddak, Inc. | CRAWLER | 1984-05-10 | 17 |
| K811489 | Fred Sammons, Inc. | SCOOTER BOARD | 1981-06-12 | 17 |
| K790528 | Maddak, Inc. | THERAPY GYROSCOPE | 1979-04-03 | 19 |
| K781198 | Fred Sammons, Inc. | BOARD, SCOOTER | 1978-07-31 | 17 |
| K780296 | Convaid Product Development | THERAPY SCOOTER | 1978-02-24 | 3 |
Recalls for KNL devices
openFDA lists no recalls for product code KNL.
Frequently asked questions
What is FDA product code KNL?
KNL is the FDA product code for board, scooter, prone. It is a Class I device, regulated under 21 CFR 890.5370 and reviewed by the Physical Medicine panel.
What device class is KNL?
Class I, regulation 21 CFR 890.5370. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code KNL?
Across 5 cleared submissions the average was 15 days from receipt to decision (median 17).
Which companies have the most KNL clearances?
Maddak, Inc. (2); Fred Sammons, Inc. (2); Convaid Product Development (1).
Next steps
- Run an FDA pathway report with predicate devices for product code KNL
- Run a recall and safety report across every KNL manufacturer
- Watch product code KNL for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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