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510(k) Data Aggregation

    K Number
    K160246
    Device Name
    SimulCare II(TM)
    Manufacturer
    XANACARE TECHNOLOGIES, LLC
    Date Cleared
    2016-10-06

    (248 days)

    Product Code
    GZJ, ILY, ISA
    Regulation Number
    882.5890
    Why did this record match?
    Applicant Name (Manufacturer) :

    XANACARE TECHNOLOGIES, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SimulCare II™ is intended for the temporary relief of minor muscle and joint pain, promoting the relaxation of muscle tissue, temporarily increasing local blood circulation, symptomatic relief and management of chronic intractable pain, and adjunctive relief of post-surgical or post-traumatic pain.
    Device Description
    The SimulCare II Multi-function Therapeutic Device is modified from the SimulCare and ComboCare 2000 devices previously cleared under 510(k)s K083202 & K081141 and includes improved interface features, EMI filters, additional audible alarm and battery monitoring circuit drain prevention. Portable, lightweight, rechargeable unit consisting of a hand-held controller with digital control of stimulation parameters and an attached flexible pad that produces battery-charged therapy consisting of red light emitting diodes, infrared light emitting diodes, micro current, macro current (E-stim), permanent magnets and vibratory massage.
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    K Number
    K083202
    Device Name
    COMBOCARE 2000
    Manufacturer
    XANACARE TECHNOLOGIES, LLC
    Date Cleared
    2008-12-15

    (46 days)

    Product Code
    GZJ, ILY, ISA
    Regulation Number
    882.5890
    Why did this record match?
    Applicant Name (Manufacturer) :

    XANACARE TECHNOLOGIES, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ComboCare 2000 is intended for the temporary relief of minor muscle and joint pain, promoting the relaxation of muscle tissue, temporarily increasing local blood circulation, symptomatic relief and management of chronic intractable pain, and adjunctive relief of post-surgical or post-traumatic acute pain.
    Device Description
    This device, modified from the ComboCare 2000 device previously cleared under 510(k) K081141, includes the addition of permanent magnets to the flexible pads to create a static magnetic field and increased Infrared light strength for therapeutic heating.
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    K Number
    K081141
    Device Name
    COMBOCARE 2000
    Manufacturer
    XANACARE TECHNOLOGIES, LLC
    Date Cleared
    2008-08-29

    (129 days)

    Product Code
    GZJ, ISA, NHN
    Regulation Number
    882.5890
    Why did this record match?
    Applicant Name (Manufacturer) :

    XANACARE TECHNOLOGIES, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ComboCare 2000 is intended for the temporary relief of minor muscle and joint pain, promoting relaxation of muscle tissue, symptomatic relief and management of chronic intractable pain, and adjunctive relief of post-surgical or post-traumatic acute pain.
    Device Description
    The ComboCare 2000 is intended for the temporary relief of minor muscle and joint pain, promoting relaxation of muscle tissue, symptomatic relief and management of chronic intractable pain, and adjunctive relief of post-surgical or post-traumatic acute pain.
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