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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Massager, Powered Inflatable Tube
510(k) Number K000655
Device Name PPCID- PNEUMATIC PERIPHERAL CIRCULATION IMPROVEMENT (FOOTREST) DEVICE
Applicant
Ahava Stein
P.O.B. 454
Ginot Shomron, 44853,  IL
Applicant Contact AHAVA STEIN
Correspondent
Ahava Stein
P.O.B. 454
Ginot Shomron, 44853,  IL
Correspondent Contact AHAVA STEIN
Regulation Number890.5650
Classification Product Code
IRP  
Date Received02/28/2000
Decision Date 03/26/2001
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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