ING

29 FDA 510(k) clearances · Product code

FDA profile

Official device name

Elevator, Wheelchair, Portable

Device class

Class II (moderate risk)

Regulation

21 CFR 890.3930

Medical specialty

Physical Medicine

Flags

Third-party review eligible

FDA 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).

Adverse events (MAUDE)

1992: 1 · 1994: 1 · 1996: 1 · 1997: 10 · 1998: 3 · 1999: 1
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.

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