BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    2004-OC MASSAGE SYSTEM, 2008-OC MASSAGE SYSTEM

    K Number: K122112 · Decision Apr 9, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    95
    Registration Numbers
    95
    Same Product Code
    152
    Applicant Total
    15
    Review Days
    266

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    Basic Information

    Device Name
    2004-OC MASSAGE SYSTEM, 2008-OC MASSAGE SYSTEM
    K Number
    K122112
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.5650
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Bio Compression Systems, Inc.
    Date Received
    July 17, 2012
    Decision Date
    April 9, 2013
    Product Code
    IRP
    Advisory Committee
    Physical Medicine
    Review Advisory Committee
    PM
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    IRP Massager, Powered Inflatable Tube

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    Other Clearances by Bio Compression Systems, Inc.

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    K180248 VascuEase IC-1200-WH
    K171793 Sequential Circulator SC-2004FC-OC
    K150953 Sequential Circulator SC-2008-OC, Sequential Circulator SC-2004-OC
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    K131306 IC-1545-DL MULTI FLO DVT COMBO INTERMITTENT PNEUMATIC COMPRESSION DEVICE
    K131327 BIOARTERIAL PLUS ARTERIAL BLOOD FLOW ENHANCEMENT SYSTEM
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