FDA product code PCD: Powered Stairway Chair Lift
PCD is the FDA product code for powered stairway chair lift. It is a Class II device, regulated under 21 CFR 890.5150 and reviewed by the Physical Medicine panel. Devices under PCD reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it. FDA has posted 3 recalls for PCD devices.
Definition
A powered patient stairway chair lift (Stair Machine) is a motorized lift equipped with a seat and permanently mounted in one location that is intended for use in mitigating mobility impairment caused by injury or other disease by moving a person up and down a stairway
Classification
| Field | Value |
|---|---|
| Device name | Powered Stairway Chair Lift |
| Device class | Class II |
| Regulation | 21 CFR 890.5150 |
| Review panel | PM — Physical Medicine |
| Medical specialty | Physical Medicine |
| Premarket route | 510(k) exempt |
Recalls for PCD devices
3 product recalls in 3 recall events; 0 initiated in the last five years and 1 still open. Most recent: 2017-04-12.
| Year | Recalls |
|---|---|
| 2017 | 1 |
Frequently asked questions
What is FDA product code PCD?
PCD is the FDA product code for powered stairway chair lift. It is a Class II device, regulated under 21 CFR 890.5150 and reviewed by the Physical Medicine panel.
What device class is PCD?
Class II, regulation 21 CFR 890.5150. Typical premarket route: 510(k) exempt.
Have PCD devices been recalled?
Yes: 3 product recalls across 3 recall events; the most recent began 2017-04-12.
Next steps
- Run an FDA pathway report with predicate devices for product code PCD
- Run a recall and safety report across every PCD manufacturer
- Watch product code PCD 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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