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    K Number
    K192731
    Device Name
    ZIDA Wearable Neuromodulation System
    Manufacturer
    Exodus Innovations
    Date Cleared
    2021-03-19

    (539 days)

    Product Code
    NAM
    Regulation Number
    876.5310
    Why did this record match?
    Applicant Name (Manufacturer) :

    Exodus Innovations

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ZIDA Wearable Neuromodulation System is a neuromodulation system that is intended to treat patients with an overactive bladder (OAB) and associated symptoms of urinary frequency, and urge incontinence.
    Device Description
    ZIDA Wearable Neuromodulation System (ZIDA System) is a home-use system that is a neuromodulation system designed to deliver non-invasive access to the sacral nerve plexus through transcutaneous electrical stimulation of the posterior tibial nerve. The method of treatment is referred to as Transcutaneous Tibial Nerve Stimulation (TTNS). The ZIDA System is a combination of the battery powered ZIDA Control Unit and the ZIDA Embedded Garment (Sock or Tights).
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