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510(k) Data Aggregation
K Number
K023230Device Name
ECHOPULSE MUSCLE STIMULATOR SYSTEM, MODEL 800
Manufacturer
Date Cleared
2003-05-05
(220 days)
Product Code
Regulation Number
890.5850Why did this record match?
Applicant Name (Manufacturer) :
WESTERN CLINICAL TECHNOLOGY SYSTEMS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
1. Relaxation of muscle spasms
Device Description
The EchoPulse 800 is an eight channel, synchronous, biphasic, powered muscle stimulator. It produces a maximum output voltage of 105 V at 500 ohm, a maximum output current of 210 mA at 500 ohm and has a pulse width of 180 usec. The 3 pin connector leads are each 72 inches long. The electrodes are 3 inch diameter Carbonflex electrodes and use 3 inch disposable sponge fabric wetable pads for application on the skin. The EchoPulse 800 measures 19 inches wide, 5 1/4 inches tall, and 12 1/2 inches deep. It weighs 27 1/4 pounds and is rack mountable.
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