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510(k) Data Aggregation

    K Number
    K233784
    Device Name
    ENSO (Model 2)
    Manufacturer
    Date Cleared
    2024-02-23

    (88 days)

    Product Code
    Regulation Number
    882.5890
    Why did this record match?
    Applicant Name (Manufacturer) :

    Hinge Health, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    A transcutaneous electrical nerve stimulation (TENS) Mode which is indicated for the symptomatic relief and management of chronic intractable pain, and for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm) and lower extremities (leg) due to strain from exercise or normal household work activities., and A powered muscle stimulation (PMS) mode which is indicated to improve and facilitate muscle performance in healthy muscles. The ENSO Model 2 should be applied to normal, healthy, dry and clean skin of adult patients.
    Device Description
    The Hinge Health ENSO® Device System consists of the main ENSO Device, a disposable Gel Pad, and a charging cable with AC adapter for recharging. The ENSO App is used to access and control the device. ENSO 2 is a wearable medical device that provides professional-grade transcutaneous electrical nerve stimulation (TENS) therapy along with an easy-to-use interface within a compact design. The device system consists of the main ENSO 2 Device, a disposable Gel Pad, and a charging cable with AC adapter for recharging the Device. ENSO 2 is controlled wirelessly using the Hinge Health app on a compatible Mobile Device.
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