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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bed, Patient Rotation, Powered
510(k) Number K950681
Device Name MODEL TURN Q PLUS AUTOMATIC TURNING MATTRESS WITH LOW AIR LOSS THERAPY
Applicant
Invacare Corp.
899 Cleveland St.
P.O. Box 4028
Elyria,  OH  44036
Applicant Contact EDWARD A KROLL
Correspondent
Invacare Corp.
899 Cleveland St.
P.O. Box 4028
Elyria,  OH  44036
Correspondent Contact EDWARD A KROLL
Regulation Number890.5225
Classification Product Code
IKZ  
Date Received02/14/1995
Decision Date 05/16/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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