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510(k) K222818

Xpedition ™ Powered Stair Chair (625700000000) by Stryker Medical — Product Code ILK

K222818 is an FDA 510(k) premarket notification submitted by Stryker Medical for the device "Xpedition ™ Powered Stair Chair (625700000000)". The FDA issued a decision of Substantially Equivalent on January 24, 2023. The device falls under product code ILK (Transport, Patient, Powered), a Class II device regulated under 21 CFR 890.5150. Stryker Medical has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 24, 2023
Date Received
September 19, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Transport, Patient, Powered
Device Class
Class II
Regulation Number
890.5150
Review Panel
PM
Submission Type

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.

Other clearances by Stryker Medical

  • K180834 — Altrix Precision Temperature Management System (August 10, 2018)
  • K171149 — Altrix Temperature Management Wraps (July 18, 2017)
  • K152266 — Altrix Precision Temperature Management System (December 2, 2016)
  • K113598 — POWER-LOAD COT FASTENER SYSTEM (December 20, 2011)
  • K946149 — STRYKER AGILITY INTENSIVE CARE BED (March 14, 1995)
  • K943864 — STRYKER 8000 SURGERY STRETCHER (August 25, 1994)
  • K935949 — STRYKER 5000 (June 17, 1994)
  • K941738 — STRYKER 5050 STRECHAIR (May 6, 1994)
  • K940068 — STRYKER OPERATING ROOM TABLE (May 5, 1994)
  • K935297 — STRYKER AMBULANCE COT MODEL 6060 (February 18, 1994)

Other clearances for product code ILK

  • K240843 — GENESIS (MS-P02-GEN) (October 7, 2024)
  • K130864 — C-MAX+ (PLUS) (February 6, 2014)
  • K121560 — LEVANT, HOMEGLIDE (November 1, 2012)
  • K121561 — FLOW2, SWING (October 26, 2012)
  • K113308 — BRUNO ELAN STAIRWAY ELEVATOR (February 1, 2012)
  • K111858 — LIFTKAR PT (November 4, 2011)
  • K103122 — C-MAX, C-MAX U1, C-MAX U1 160KG, C-MAX U2, C-MAX U2 160KG, S-MAX, S-MAX AVIATION (December 30, 2010)
  • K093946 — HOVEROUND HOVERGLIDE MODEL HOVERGLIDE MK-2 (March 22, 2010)
  • K091858 — PINNACLE STAIR WAY LIFT (July 1, 2009)
  • K073110 — MERITS E600 SERIES STAIR LIFT (February 6, 2008)

FDA data resources