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

    Normatec Elite Hip

    K Number: K251905 · Decision Sep 18, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    95
    Registration Numbers
    95
    Same Product Code
    152
    Applicant Total
    9
    Review Days
    90

    Basic Information

    Device Name
    Normatec Elite Hip
    K Number
    K251905
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.5650
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    NormaTec Industries, LP
    Date Received
    June 20, 2025
    Decision Date
    September 18, 2025
    Product Code
    IRP
    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
    IRP Massager, Powered Inflatable Tube

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    Other Clearances by NormaTec Industries, LP

    K Number Device Name
    K240122 Normatec Elite
    K221666 Normatec Go
    K220217 Normatec 3
    K183169 Pulse 2.0, Pulse Pro 2.0
    K183328 Pulse Rx 2.0, Pulse Pro Rx 2.0
    K161346 NormaTec PCD-T and PCD-B
    K160608 NormaTec Pulse and NormaTec Pulse Pro
    K112890 NORMATEC MVP