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    K Number
    K133483
    Device Name
    PORTABLE THERAPEUTIX SQUID ACTIVE COLD COMPRESSION DEVICE AND COLD PACK FOR OTC USE
    Manufacturer
    PORTABLE THERAPEUTIX
    Date Cleared
    2014-03-11

    (118 days)

    Product Code
    IRP, IME
    Regulation Number
    890.5650
    Why did this record match?
    Applicant Name (Manufacturer) :

    PORTABLE THERAPEUTIX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Squid Active Cold Compression device and Cold Pack for the temporary relief of minor muscle aches and pains. The compression device is indicated for temporary increase in circulation of the treated areas in people who are in good health, and simulates kneeding and stroking of tissues using an inflatable garment. The cold pack is indicated for localized therapy in situations where cold temperature therapy is necessary or desirable.
    Device Description
    The Squid Active Cold Compression device and Cold Pack for OTC Use combines intermittent compression with cold therapy. The Squid simulates kneading and stroking of tissues using an inflatable garment attached to a gel ice pack and connected to a preprogrammed air pump. The Squid may be used for the leg, foot, feet, arm, shoulders, lower back, and hands. The device is manufactured with the following components: - 1. A portable external pump-controller unit containing the pneumatic compressor (air pump) that may be run on AC-DC external power supply or a built-in lithium battery. - 2. A wrap that contains an air bladder with sequential compression capability and Velcro attachments for the cold pack. The wrap connects to the pump controller via a flexible tube. There may also be an accessory piece to the wrap to provide an additional securing mechanism. Wraps come in two configurations and three sizes. - 3. Reusable thermogel cold pack
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    K Number
    K123829
    Device Name
    PORTABLE THERAPEUTIX SQUID ACTIVE COLD COMPRESSION DEVICE AND COLD PACK
    Manufacturer
    PORTABLE THERAPEUTIX, LLC
    Date Cleared
    2013-04-03

    (112 days)

    Product Code
    IRP, IME
    Regulation Number
    890.5650
    Why did this record match?
    Applicant Name (Manufacturer) :

    PORTABLE THERAPEUTIX, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Squid Active Cold Compression device and Cold Pack is indicated for the temporary relief of minor muscle aches and pains. The compression device is indicated for temporary increase in circulation of the treated areas in people who are in good health, and simulates kneeding and stroking of tissues using an inflatable garment. The cold pack is indicated for localized therapy in situations where a physician determines that cold temperature therapy is necessary or desirable.
    Device Description
    The Squid Active Cold Compression device and Cold Pack combines intermittent compression with cold therapy. The Squid simulates kneading and stroking of tissues using an inflatable garment attached to a gel ice pack and connected to a pre-programmed air pump. The Squid may be used for the leg, foot, feet, arm, shoulders, lower back, and hands. The device is manufactured with the following components: 1. A portable external pump-controller unit containing the pneumatic compressor (air pump) that may be run on AC-DC external power supply or a built-in lithium battery. 2. A wrap that contains an air bladder with sequential compression capability and Velcro attachments for the cold pack. The wrap connects to the pump controller via a flexible tube. There may also be an accessory piece to the wrap to provide an additional securing mechanism. Wraps come in two configurations and three sizes. 3. Reusable thermogel cold pack
    Ask a Question

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