510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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PCEClass II

Permanently Mounted Wheelchair Platform Lift

21 CFR 890.3930 / Physical Medicine
FDA source (opens on fda.gov)

PCE is the FDA product code for Permanently Mounted Wheelchair Platform Lift, a class II device type, regulated under 21 CFR 890.3930. FDA's definition for this code reads: "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". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
PCE
Device name
Permanently Mounted Wheelchair Platform Lift
FDA 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.
Regulation
21 CFR 890.3930
Device class
Class II
Review panel
Physical Medicine
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
1
Ingested recalls
0

Clearances, product code PCE

By decision year
1 clearance under product code PCE with a decision year between 2013 and 2013, 2013 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code PCE by decision year
YearClearances
20131

Applicants with the most clearances

Product code PCE
Applicants holding the most 510(k) clearances under product code PCE
ApplicantClearances
Garaventa (Canada) Ltd [dba Garaventa Lift]1

Companies listing this code with FDA

Companies whose registered establishments list this code