FDA product code PCE: Permanently Mounted Wheelchair Platform Lift
PCE is the FDA product code for permanently mounted wheelchair platform lift. It is a Class II device, regulated under 21 CFR 890.3930 and reviewed by the Physical Medicine panel. FDA has cleared 1 510(k) submission under PCE. The average 510(k) review took 239 days (median 239).
Definition
Intended for medical purposes to provide a guided platform to move a person with impaired mobility, with or without a wheelchair, from one level to another.
Classification
| Field | Value |
|---|---|
| Device name | Permanently Mounted Wheelchair Platform Lift |
| Device class | Class II |
| Regulation | 21 CFR 890.3930 |
| Review panel | PM — Physical Medicine |
| Medical specialty | Physical Medicine |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every PCE clearance
Top PCE applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Garaventa (Canada) Ltd [Dba Garaventa Lift] | 1 | 2013-03-21 |
Most recent PCE clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K122206 | Garaventa (Canada) Ltd [Dba Garaventa Lift] | GARAVENTA X3 INCLINED PLATFORM LIFT | 2013-03-21 | 239 |
Recalls for PCE devices
openFDA lists no recalls for product code PCE.
Frequently asked questions
What is FDA product code PCE?
PCE is the FDA product code for permanently mounted wheelchair platform lift. It is a Class II device, regulated under 21 CFR 890.3930 and reviewed by the Physical Medicine panel.
What device class is PCE?
Class II, regulation 21 CFR 890.3930. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code PCE?
Across 1 cleared submissions the average was 239 days from receipt to decision (median 239).
Which companies have the most PCE clearances?
Garaventa (Canada) Ltd [Dba Garaventa Lift] (1).
Next steps
- Run an FDA pathway report with predicate devices for product code PCE
- Run a recall and safety report across every PCE manufacturer
- Watch product code PCE 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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