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510(k) Data Aggregation

    K Number
    DEN100023
    Device Name
    AHIP INTERNAL TRIGGER POINT WAND MODEL: 1
    Date Cleared
    2012-11-20

    (823 days)

    Product Code
    Regulation Number
    890.5670
    Why did this record match?
    Applicant Name (Manufacturer) :

    NATIONAL CENTER FOR PELVIC PAIN RESEARCH DEVICES,

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The AHIP Internal Trigger Point Wand is a self-massager used to massage irritable, sore trigger points in the pelvic floor musculature to reduce internal pelvic floor trigger point sensitivity. It helps to relieve painful trigger points through this direct, manual therapeutic massage technique. Painful intrapelvic trigger points are associated with chronic pelvic pain syndromes.
    Device Description
    The AHIP Internal Trigger Point Wand is a single-patient-use internal therapeutic massager as depicted in Figure 1. The wand (ULTEM®) consists of a ball pressure applicator (Santoprene™) on a rod with a distal hook-shaped curve. A strain gauge is attached to the straight portion of the wand, which is connected to a battery-operated readout device that measures the amount of pressure being exerted at the tip of the wand. The wand also has an adjustable "stop" (to be set by the therapist) to limit the depth of insertion. The wand is to be covered with a disposable covering and lubricant (e.g., FDA-cleared KY-Jelly or other waterbased lubricants without sensates) prior to use.
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