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510(k) Data Aggregation
K Number
K141208Device Name
DYNAMIC NEUROSCREENING DEVICE
Manufacturer
PROSENEX
Date Cleared
2014-07-23
(75 days)
Product Code
LQW, LLN
Regulation Number
882.1200Why did this record match?
Applicant Name (Manufacturer) :
PROSENEX
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Dyaamic Newssreaing Device (DND) is intended to provide objective medical screening for peripheral newopathy by determining the patient's ability to discriminate temperature differences as well as determining vibration sensitivity.
Device Description
The Dynamic Neuroscreening Device (DND) is intended to screen patients and allow the practitioner to observe uny changes of sensation over a period of time. The device will be available with a cradle which provides a docking location for the handle. The DND device provides medical practitioners with an objective method for screening patient's feet for neuropathy. The device uses two methods for long term screening with the objective of determining loss of sensation in the patient's foot: vibration sensitivity and temperature discrimination screening. The primary patient population is for those that arc at risk or have been diagnosed with diabetes.
The DND is designed to be ergonomically comfortable in the practitioner's hand and simple to use. In addition safety features are installed to provent the device from becoming excessively hot or cold to ensure untient safety. No electrical pathways are going to the patient and the power supply is UL upproved to the medical device standard.
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