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510(k) Data Aggregation
K Number
K031995Device Name
COMPREHENSIVE NEUROMUSCULAR PROFILER
Manufacturer
MEDICAL TECHNOLOGIES UNLIMITED, INC.
Date Cleared
2004-01-07
(194 days)
Product Code
IKN
Regulation Number
890.1375Why did this record match?
Applicant Name (Manufacturer) :
MEDICAL TECHNOLOGIES UNLIMITED, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Surface electromyography with range of motion tracking, functional capacity and grip strength measuring.
Device Description
The Comprehensive Neuromuscular Profiler is a muscle and range of motion monitoring system that is portable, stand-alone and in a convenient package suitable for use in a medical environment. The system consists of a number of sensors to be connected to various parts of the human body which will be fed into a customized enclosure containing all connectors and mediums for conditioning, acquiring and transferring the sensor data. The conditioned data will then be sent to the notebook computer (PC) that is connected to the enclosure. The system will be capable of monitoring and recording data from electromyography (EMG) sensors connected to various muscle groups in the human body. During the acquisition of EMG signals, the system will simultaneously acquire motion of the body and/or muscle strength.
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