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510(k) Data Aggregation

    K Number
    DEN240021
    Device Name
    Tango® Belt (Model SAS-001-01 (XS); Model SAS-001-02 (S); Model SAS-001-03 (M); Model SAS-001-04 (L); Model SAS-001-05 (XL))
    Manufacturer
    Active Protective Technologies, Inc.
    Date Cleared
    2025-04-09

    (328 days)

    Product Code
    SEC
    Regulation Number
    890.3780
    Type
    Direct
    Panel
    Physical Medicine
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    Tango**®** Belt (Model SAS-001-01 (XS); Model SAS-001-02 (S); Model SAS-001-03 (M); Model SAS-001-04 (L);

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    Device Description
    AI/ML Overview
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