FDA product code KNO: Accessories, Wheelchair
KNO is the FDA product code for accessories, wheelchair. It is a Class I device, regulated under 21 CFR 890.3910 and reviewed by the Physical Medicine panel. FDA has cleared 35 510(k) submissions under KNO, from 7 different applicants. The average 510(k) review took 24 days (median 17). FDA has posted 3 recalls for KNO devices.
Classification
| Field | Value |
|---|---|
| Device name | Accessories, Wheelchair |
| Device class | Class I |
| Regulation | 21 CFR 890.3910 |
| Review panel | PM — Physical Medicine |
| Medical specialty | Physical Medicine |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Compare with all 510(k) review times · Search every KNO clearance
Top KNO applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Fred Sammons, Inc. | 25 | 1983-01-21 |
| Orthopedic Equipment Co., Inc. | 4 | 1978-03-09 |
| Skil-Care Corp. | 2 | 1980-07-14 |
| Redman, Inc. | 1 | 1987-02-26 |
| Danek Medical, Inc. | 1 | 1983-01-14 |
2 more applicants have KNO clearances. See the full list in Caduvo.
Most recent KNO clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K870298 | Redman, Inc. | REDMAN ACCESSORIES | 1987-02-26 | 29 |
| K823646 | Fred Sammons, Inc. | FRICTION FEEDER | 1983-01-21 | 46 |
| K823645 | Fred Sammons, Inc. | VELCRO STRAPS TO HOLD ARM TO WHEELCHAIR | 1983-01-21 | 46 |
| K823816 | Danek Medical, Inc. | WHEELCHAIR PATIENT RESTRAINTS | 1983-01-14 | 28 |
| K823635 | Fred Sammons, Inc. | CUSHIONS FOR WHEELCHAIR ARMS | 1982-12-28 | 22 |
Recalls for KNO devices
3 product recalls in 3 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2020-03-02.
| Year | Recalls |
|---|---|
| 2020 | 1 |
Frequently asked questions
What is FDA product code KNO?
KNO is the FDA product code for accessories, wheelchair. It is a Class I device, regulated under 21 CFR 890.3910 and reviewed by the Physical Medicine panel.
What device class is KNO?
Class I, regulation 21 CFR 890.3910. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code KNO?
Across 35 cleared submissions the average was 24 days from receipt to decision (median 17).
Which companies have the most KNO clearances?
Fred Sammons, Inc. (25); Orthopedic Equipment Co., Inc. (4); Skil-Care Corp. (2); Redman, Inc. (1); Danek Medical, Inc. (1).
Have KNO devices been recalled?
Yes: 3 product recalls across 3 recall events; the most recent began 2020-03-02.
Next steps
- Run an FDA pathway report with predicate devices for product code KNO
- Run a recall and safety report across every KNO manufacturer
- Watch product code KNO 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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