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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Exerciser, Measuring
510(k) Number K861348
Device Name R1361 & R1372 MEASURED EXERCISE EQUIPMENT
Applicant
TRI W-G, INC.
P.O. BOX 905
VALLEY CITY,  ND  58072
Applicant Contact JOHN WEBER
Correspondent
TRI W-G, INC.
P.O. BOX 905
VALLEY CITY,  ND  58072
Correspondent Contact JOHN WEBER
Regulation Number890.5360
Classification Product Code
ISD  
Date Received04/07/1986
Decision Date 05/02/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
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