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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wheelchair, Mechanical
510(k) Number K240120
Device Name Merlexi Craft Bariatric series of manual wheelchairs
Applicant
Turbo Wheelchair Co., Inc.
247 America Place
Jeffersonville,  IN  47130
Applicant Contact Jane Hermes
Correspondent
Turbo Wheelchair Co., Inc.
247 America Place
Jeffersonville,  IN  47130
Correspondent Contact Jane Hermes
Regulation Number890.3850
Classification Product Code
IOR  
Date Received01/16/2024
Decision Date 07/05/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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