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510(k) Data Aggregation
K Number
K022719Device Name
PHYSICAL MONITORING REGISTRATION UNIT
Manufacturer
MARYROSE CUSIMANO, PH.D./PHIL REASTON
Date Cleared
2002-11-13
(90 days)
Product Code
IKN
Regulation Number
890.1375Why did this record match?
Applicant Name (Manufacturer) :
MARYROSE CUSIMANO, PH.D./PHIL REASTON
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
To provide non-invasive muscle testing integrating with range of motion, functional capacity of lifting, pulling, pushing, pinching and gripping. To pinpoint muscle activity during movement objectively isolating abnormal movements with abnormal muscle patterns. To establish relative functioning of muscle in any specific anomaly that may occur due to muscle damage, muscle fatigue, hypertonicity or stress. To pinpoint referred pain pattern associated with cervical, thoracic, lumbosacral upper and lower extremities. and refer pain sources. To evaluate a baseline muscle activity for pre-employment screening, sport medicine. To look at chronic vs. acute muscle function and range of motion to ascertain good effort with FCE, range of motion, and gripping, and pinch. To ascertain the ischemic activity of muscles. To ascertain chronic damage to muscles. To monitor the frequency range for cardiac muscle.
Device Description
The Physical Monitoring Registration Unit, (PMRU) combines up to 48 channels allowing for a minimum of 18 channels of refined surface EMG to monitor any muscle group in the body. This is also beneficial in monitoring the cardiac muscle. This system also features lead status circuitry to integrate correct placement of all EMG electrodes. The additional channels monitor functional capacity sensors range of motion, the J-Mar grip and pinch strength measurement devices.
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