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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 K213533
Device Name Sequential Circulators SC-1004-DL, SC-1008-DL, SC-2004-DL, SC-2008-DL, SC-4004-DL, SC-4008-DL
Applicant
Bio Compression Systems, Inc.
120 W. Commercial Ave.
Moonachie,  NJ  07074
Applicant Contact Marc Somelofski
Correspondent
Bio Compression Systems, Inc.
120 W. Commercial Ave.
Moonachie,  NJ  07074
Correspondent Contact Marc Somelofski
Regulation Number890.5650
Classification Product Code
IRP  
Date Received11/05/2021
Decision Date 02/16/2022
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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