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510(k) Data Aggregation

    K Number
    K971592
    Device Name
    XTANK2 MOBILE EXTREMITY WHIRLPOOL SYSTEM
    Manufacturer
    Date Cleared
    1998-02-26

    (301 days)

    Product Code
    Regulation Number
    890.5100
    Why did this record match?
    Applicant Name (Manufacturer) :

    THE SILCRAFT CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Hydromassage treatment of the user's extremities
    Device Description
    The Silcraft XTank2 and the Ferno IIIe have very similar technological characteristics. Each of these device primarily consists of the following components: (1) a tank to be filled with water; (2) a fill hose; (3) a base with four castors or wheels: (4) a handle to lift the device: (5) a control console; (6) a whirlpool motor: (7) whirlpool jets; (8) a power drain pump; (9) a manual drain and handle; and (10) a power supply cord.
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    K Number
    K971593
    Device Name
    SILCRAFT ACCESS 3700 WHIRLPOOL SYSTEM, SILCRAFT MODEL 1800 LIFT, SILCRAFT DISINFECTANT
    Manufacturer
    Date Cleared
    1998-02-26

    (301 days)

    Product Code
    Regulation Number
    890.5100
    Why did this record match?
    Applicant Name (Manufacturer) :

    THE SILCRAFT CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Models 2001, 3700D, 3600, and 3600XL: Full immersion bathing and hydromassage of the lower extremities of patients in a sitting position. Models 2300 and 3300: Full immersion and hydromassage of patients in a sitting position. Models 4300, 5300, 4400SS, and 5400SS: Full immersion bathing and hydromassage of patients in a reclining position.
    Device Description
    Ten of the eleven models of the Silcraft Whirlpool System and all of the predicate devices consist primarily of the following components: (1) a tub; (2) a shower wand; (3) a control console; (4) a water temperature control; (5) a whirlpool motor; (6) multiple whirlpool jets; and (7) a built-in automatic or manual disinfection system. One models does not have a built-in disinfection system. Each model of the Silcraft Whirlpool System and all of the predicate devices are labeled for use with one or more patient lift and/or transfer devices, including certain Silcraft transporters and lifts ("the Silcraft Patient Lift").
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