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510(k) Data Aggregation
K Number
K943535Device Name
MODEL ME 300 MUSCLE TESTER
Manufacturer
Date Cleared
1997-06-25
(1070 days)
Regulation Number
882.5050Why did this record match?
Applicant Name (Manufacturer) :
REGULATORY STRATEGIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The intended use of the Model ME300 Muscle Tester is to record EMG sensory feedback signals to be used in various programs of muscle reeducation and relaxation training.
Device Description
The ME300 is a portable, battery powered EMG recorder. The ME300 is an electronic device used to gather and display electrophysiological signals obtained from muscle activity. These signals are used in programs related to muscle re-education and relaxation training. The signals are received via conductive adhesive skin electrodes and may be displayed or stored for display at a later time. Signals may be gathered from two channels. Data downloading or transfer is via a standard fiber optic cable to a PC. The product does not relay any electrical or stimulatory signals to the body. It is only a signal recorder with display capabilities.
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