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

    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))

    K Number: DEN240021 · Decision Apr 9, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    0
    Applicant Total
    1
    Review Days
    328

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    Basic Information

    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))
    K Number
    DEN240021
    Device Class
    FDA class 2
    Clearance Type
    Direct
    Regulation Number
    890.3780
    Medical Specialty
    Physical Medicine
    Decision
    Unknown
    Applicant
    Active Protective Technologies, Inc.
    Date Received
    May 16, 2024
    Decision Date
    April 9, 2025
    Product Code
    SEC
    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
    SEC Wearable Fall Injury Prevention Device