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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Transport, Patient, Powered
510(k) Number K222818
Device Name Xpedition ™ Powered Stair Chair (625700000000)
Applicant
Stryker Medical
3800 E. Centre Ave.
Portage,  MI  49002
Applicant Contact Rachel Stallworth
Correspondent
Stryker Medical
3800 E. Centre Ave.
Portage,  MI  49002
Correspondent Contact Rachel Stallworth
Regulation Number890.5150
Classification Product Code
ILK  
Date Received09/19/2022
Decision Date 01/24/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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