inforMED
IMKClass II

Wheelchair, Stair Climbing

Physical Medicine · 21 CFR 890.3890

A device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position. The device is intended to climb stairs. FDA interprets “mobility to persons restricted to a sitting position” to mean the device type is intended to provide mobility to individuals who have mobility impairments and require an assistive device for mobility.

MDR events79All time
Recalls4All time
Registered firms6Currently listed
510(k) clearances3All time

Recent MDR events

79 adverse event reports on file

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Event type breakdown

Other46
Injury25
Malfunction7
Unspecified1

Most-reported manufacturers

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Independence Technology, L.l.c.35Mobius Mobility Llc.17Independence Technology, Llc13Independence Technology, Llc.5Mobius Mobiliyt Llc.4Independence Technology, Llc,1Johnson & Johnson Independence Tech.1Stryker Corp, Medical Division1

Recalls

4 recall events for this product code

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Registered firms

6 firms currently registered for this product code

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510(k) clearances

3 clearances for this product code

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PMA approvals

2 premarket approvals for this product code

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