FDA product code KNN: Components, Wheelchair
KNN is the FDA product code for components, wheelchair. It is a Class I device, regulated under 21 CFR 890.3920 and reviewed by the Physical Medicine panel. FDA has cleared 64 510(k) submissions under KNN, 1 in the last five years, from 38 different applicants. The average 510(k) review took 59 days (median 27). FDA has posted 11 recalls for KNN devices, 10 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Components, Wheelchair |
| Device class | Class I |
| Regulation | 21 CFR 890.3920 |
| Review panel | PM — Physical Medicine |
| Medical specialty | Physical Medicine |
| Premarket route | 510(k) exempt |
510(k) clearances per year for KNN
| Year | Clearances | Avg. review days |
|---|---|---|
| 2022 | 1 | 256 |
Compare with all 510(k) review times · Search every KNN clearance
Top KNN applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Pin Dot Products, Inc. | 10 | 1991-09-05 |
| Berkeley Electric Wheelchair Co. | 5 | 1983-01-14 |
| Foley & Lardner | 4 | 1994-11-07 |
| Rolcontrol Products, Co., Inc. | 4 | 1988-12-27 |
| Fred Sammons, Inc. | 4 | 1983-01-21 |
33 more applicants have KNN clearances. See the full list in Caduvo.
Most recent KNN clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K211919 | Kinetic Innovative Seating System, LLC | KISS Dynamic Back Support, KISS Dynamic Solid Drop Seat | 2022-03-04 | 256 |
| K942309 | Foley & Lardner | DYNASTY U1-31 (GELL/CELL) | 1994-11-07 | 178 |
| K942311 | Foley & Lardner | DYNASTY U1-33 AGM | 1994-11-07 | 178 |
| K942310 | Foley & Lardner | DYNASTY GC 12550 (GELL/CELL) | 1994-11-07 | 178 |
| K942308 | Foley & Lardner | DYNASTY GC 12400 (GELL/CELL) | 1994-11-07 | 178 |
Recalls for KNN devices
11 product recalls in 5 recall events; 10 initiated in the last five years and 10 still open. Most recent: 2026-06-19.
| Year | Recalls |
|---|---|
| 2023 | 3 |
| 2025 | 6 |
| 2026 | 1 |
Frequently asked questions
What is FDA product code KNN?
KNN is the FDA product code for components, wheelchair. It is a Class I device, regulated under 21 CFR 890.3920 and reviewed by the Physical Medicine panel.
What device class is KNN?
Class I, regulation 21 CFR 890.3920. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code KNN?
Across 64 cleared submissions the average was 59 days from receipt to decision (median 27).
Which companies have the most KNN clearances?
Pin Dot Products, Inc. (10); Berkeley Electric Wheelchair Co. (5); Foley & Lardner (4); Rolcontrol Products, Co., Inc. (4); Fred Sammons, Inc. (4).
Have KNN devices been recalled?
Yes: 11 product recalls across 5 recall events; the most recent began 2026-06-19.
Next steps
- Run an FDA pathway report with predicate devices for product code KNN
- Run a recall and safety report across every KNN manufacturer
- Watch product code KNN 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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