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510(k) Data Aggregation

    K Number
    K150180
    Device Name
    InTone
    Manufacturer
    INCONTROL MEDICAL, LLC.
    Date Cleared
    2015-03-16

    (48 days)

    Product Code
    KPI, HIR
    Regulation Number
    876.5320
    Why did this record match?
    Applicant Name (Manufacturer) :

    INCONTROL MEDICAL, LLC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    InTone is intended to provide electrical stimulation and/or visual biofeedback (via manometry) for the treatment of female urinary incontinence.
    Device Description
    The InTone device includes three parts: an Insertion Unit, a Control Unit, and a Software Application for clinicians. - The Insertion Unit includes an inflation pump and an inflatable probe. The inflatable probe is inserted into the vagina and the inflation pump is used by the patient to manually inflate the probe, ensuring a customized fit. Electrical stimulation is delivered via stainless steel electrodes on the inflatable probe to induce a contraction of the pelvic floor muscles. Biofeedback is monitored via a pressure sensor within the Insertion Unit which records changes in pressure related to volitional muscle contraction. - The Control Unit includes user keys to initiate and control treatment sessions, and a visual biofeedback graph to encourage muscle re-training. The Control Unit is designed to record and store results of the electrical stimulation and biofeedback sessions for clinician review at follow-up visits. - The Software Application is utilized by the clinician to program the Control Unit and display the results of electrical stimulation and biofeedback sessions. The Software Application allows the clinician to select and lock in the appropriate electrical stimulation level necessary to stimulate pelvic floor contraction.
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