PCD · Class II — Moderate Risk (510(k) clearance required) · Physical Medicine · 21 CFR 890.5150
Classification
FDA Product Code
PCD
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 890.5150
Review panel
PM
Medical specialty
Physical Medicine
Submission type
4
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
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