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510(k) Data Aggregation

    K Number
    DEN180057
    Device Name
    IB-Stim
    Manufacturer
    Innovative Health Solutions (IHS), Inc.
    Date Cleared
    2019-06-07

    (225 days)

    Product Code
    QHH
    Regulation Number
    876.5340
    Why did this record match?
    Applicant Name (Manufacturer) :

    Innovative Health Solutions (IHS), Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The IB-Stim is a percutaneous electrical nerve field stimulator (PENFS) system intended to be used in patients 11-18 years of age with functional abdominal pain associated with irritable bowel syndrome (IBS). The IB-Stim is intended to be used for 120 hours per week up to 3 consecutive weeks, through application to branches of Cranial Nerves V, VII, IX and X, and the occipital nerves identified by transillumination, as an aid in the reduction of pain when combined with other therapies for IBS.
    Device Description
    The IB-Stim is a device that delivers electrical stimulation through percutaneous electrodes to areas usually innervated by branches of occipital nerves and cranial nerves V, VII, IX and X that are located by transillumination. The device consists of (1) a percutaneous electrical nerve field stimulator (PENFS), (2) a multi-pin wire harness percutaneous electrode array, and (3) a pen light for use in the transillumination technique that aids in positioning of the percutaneous electrodes (Figure 1). The wire harness percutaneous electrode array consists of 4 leads. The 1-1-1-4 configuration consists of three single-needle leads, and one 4-needle array (Figure 2). The stimulator is placed behind the ear and the percutaneous electrodes are positioned utilizing the transillumination function of the device (Figure 1). The transillumination technique assists in the visualization of the vasculature of the ear to aid in the placement of the percutaneous electrodes near the nerve branches in the ear.
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    K Number
    DEN170018
    Device Name
    NSS-2 System
    Manufacturer
    Innovative Health Solutions (IHS), Inc.
    Date Cleared
    2017-11-15

    (243 days)

    Product Code
    PZR
    Regulation Number
    882.5896
    Why did this record match?
    Applicant Name (Manufacturer) :

    Innovative Health Solutions (IHS), Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The NSS-2 BRIDGE is a percutaneous nerve field stimulator (PNFS) system, that can be used as an aid to reduce the symptoms of opioid withdrawal, through application to branches of Cranial Nerves V, VII, IX and X, and the occipital nerves identified by transillumination.
    Device Description
    NSS-2 BRIDGE is a device that electrically stimulates branches of Cranial Nerves V. VII. IX and X, and the occipital nerves identified by transillumination through percutaneous electrodes to aid in the reduction of opioid withdrawal symptoms. The device consists of (1) a percutaneous nerve field stimulator (PNFS; Figure 1), (2) a multi-pin wire harness percutaneous electrode array (Figure 2), and (3) a pen light for use in the transillumination technique that aids in positioning of the percutaneous electrodes (Figure 3).
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