ING · Class II — Moderate Risk (510(k) clearance required) · Physical Medicine · 21 CFR 890.3930
Classification
FDA Product Code
ING
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 890.3930
Review panel
PM
Medical specialty
Physical Medicine
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
Y
Definition
A motorized lift device that is not permanently mounted in one location and that is intended for medical purposes to provide a means to move a person with impaired mobility, with or without a wheelchair, from one level to another (e.g., portable platform lifts, attendant-operated stair climbing devices for wheelchairs).