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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 K051090
Device Name X-CHANGE
Applicant
MEYRA
12801 EAST INDEPENDENCE BLVD.
MATTHEWS,  NC  28106
Applicant Contact KIRK MACKENZIE
Correspondent
MEYRA
12801 EAST INDEPENDENCE BLVD.
MATTHEWS,  NC  28106
Correspondent Contact KIRK MACKENZIE
Regulation Number890.3850
Classification Product Code
IOR  
Date Received04/28/2005
Decision Date 05/13/2005
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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