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510(k) Data Aggregation
K Number
K060125Device Name
SONIC PALPOMETER
Manufacturer
PALPOMETER SYSTEMS, INC.
Date Cleared
2006-03-16
(57 days)
Product Code
IKE
Regulation Number
890.1615Why did this record match?
Product Code :
IKE
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The intended use of the Sonic Palpometer is to assess patient sensitivity to tactile stimulus by providing quantification of fingertip pressure, for tactile response procedures and freatments that use digital palpation.
Device Description
The Palpometer is a simple device that combines the fine motor and sensory attributes of manual examination with the precision measurements made with pressure gauges. By measuring the amount of pressure between the device and a soft tissue, the Palpometer standardizes pain response by controlling the pressure of the examiner's palpating finger. The Palpometer consists of a thin sensor, positioned on the palpating portion of the examiner's finger. The sensor changes its electrical resistance caused by varying the pressure exercised by the examining finger. The Palpometer beeps in a different tone as you pass through each programmable pressure threshold (of which there are five).
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