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510(k) Data Aggregation
K Number
K973450Device Name
SENSOR PAD
Manufacturer
INVENTIVE PRODUCTS, INC.
Date Cleared
1997-11-14
(64 days)
Product Code
IYO
Regulation Number
892.1560Why did this record match?
Applicant Name (Manufacturer) :
INVENTIVE PRODUCTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Sensor Pad is indicated as an aid for performing breast self-examination.
Device Description
The Sensor Pad® is a thin polyether polyurethane bladder, 9.5 inches in diameter containing a small quantity of a lubricating fluid. The very thin nature of the polyether polyurethane allows the pad to conform to the shape of the tissues underlying it. The very low coefficient of friction property of the silicone fluid in combination with the very thin and flexible bladder, results in an easy sliding relationship between the upper and lower surfaces of the bladder. Therefore when properly used between the finger and the soft tissues of the patient, a reduction of friction is observed.
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