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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Exerciser, Powered
510(k) Number K872639
Device Name DELUXE MOTORIZED TREADMILL MODEL #FT2300
Applicant
Invacare Corp.
899 Cleveland St.
P.O. Box 4028
Elyria,  OH  44036
Applicant Contact JAMES R THALER
Correspondent
Invacare Corp.
899 Cleveland St.
P.O. Box 4028
Elyria,  OH  44036
Correspondent Contact JAMES R THALER
Regulation Number890.5380
Classification Product Code
BXB  
Date Received07/06/1987
Decision Date 09/18/1987
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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