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510(k) Data Aggregation
K Number
DEN100023Device Name
AHIP INTERNAL TRIGGER POINT WAND MODEL: 1
Date Cleared
2012-11-20
(823 days)
Product Code
Regulation Number
890.5670Why 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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