Cleared Traditional

K222818 - Xpedition ? Powered Stair Chair (625700000000)
(FDA 510(k) Clearance)

K222818 · Stryker Medical · Physical Medicine
Jan 2023
Decision
127d
Days
Class 2
Risk

K222818 is an FDA 510(k) clearance for the Xpedition ? Powered Stair Chair (625700000000). This device is classified as a Transport, Patient, Powered (Class II — Special Controls, product code ILK).

Submitted by Stryker Medical (Portage, US). The FDA issued a Cleared decision on January 24, 2023, 127 days after receiving the submission on September 19, 2022.

This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5150. A Powered Patient Transport Is A Motorized Device Intended For Use In Mitigating Mobility Impairment Caused By Injury Or Other Disease By Moving A Person From One Location Or Level To Another, Such As Up And Down Flights Of Stairs (e.g., Attendant-operated Portable Stair-climbing Chairs). This Generic Type Of Device Does Not Include Motorized Three-wheeled Vehicles Or Wheelchairs..

Submission Details

510(k) Number K222818 FDA.gov
FDA Decision Cleared SESE
Date Received September 19, 2022
Decision Date January 24, 2023
Days to Decision 127 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF

Device Classification

Product Code ILK — Transport, Patient, Powered
Device Class Class II — Special Controls
CFR Regulation 21 CFR 890.5150
Definition A Powered Patient Transport Is A Motorized Device Intended For Use In Mitigating Mobility Impairment Caused By Injury Or Other Disease By Moving A Person From One Location Or Level To Another, Such As Up And Down Flights Of Stairs (e.g., Attendant-operated Portable Stair-climbing Chairs). This Generic Type Of Device Does Not Include Motorized Three-wheeled Vehicles Or Wheelchairs.