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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 K964957
Device Name INTERMITTENT COMPRESSOR SYSTEM
Applicant
Eischoco, Inc.
1232 SE 282nd Ave.
Gresham,  OR  97080
Applicant Contact CLEMENT EISCHEN
Correspondent
Eischoco, Inc.
1232 SE 282nd Ave.
Gresham,  OR  97080
Correspondent Contact CLEMENT EISCHEN
Regulation Number890.5650
Classification Product Code
IRP  
Date Received12/11/1996
Decision Date 02/24/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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