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510(k) Data Aggregation

    K Number
    K251905
    Date Cleared
    2025-09-18

    (90 days)

    Product Code
    Regulation Number
    890.5650
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Normatec Elite Hip is an air pressure massager intended to temporarily relieve minor muscle aches and/or pains, and to temporarily increase circulation to the treated areas.

    Device Description

    The Normatec Elite Hip is a powered inflatable tube massager (Product Code "IRP"). It is intended to temporarily relieve minor muscle aches and/or pains, and to temporarily increase circulation to the treated areas. It simulates manual kneading and stroking of tissues by the use of an inflatable pressure cuff. The devices are to be used by people who are in good health. The devices are charged and powered from an external compliant power supply. In addition, powered by an internal IEC 62133-2 compliant lithium-ion battery.

    The user interface on the Normatec Elite Hip is a series of buttons with a small display screen to display the treatment time, pressure level, zone boost number. The user interface provides for:

    • Starting and stopping the massage treatment;
    • Adjusting time and intensity (pressure) of the treatment;
    • Selection of the zone to boost the pressure

    In addition to the user interface on the devices, the proposed devices have Bluetooth capability that allows the use of a NormaTec app to control the device. The Bluetooth app allows the user to use a compatible Android or iOS phone to select and set device parameters listed above for convenience.

    AI/ML Overview

    N/A

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