Permanently Mounted Wheelchair Platform Lift

PCE · Class II — Moderate Risk (510(k) clearance required) · Physical Medicine · 21 CFR 890.3930

Classification

FDA Product Code: PCE
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 890.3930
Review panel: PM
Medical specialty: Physical Medicine
Submission type: 4
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

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.

Market data

Cleared 510(k) submissions: 1
Registered establishments: 11

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown