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510(k) Data Aggregation
K Number
K955736Device Name
STIM-8
Manufacturer
Date Cleared
1996-05-22
(156 days)
Product Code
Regulation Number
890.5850Why did this record match?
Applicant Name (Manufacturer) :
BMR LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Stim-8 is used for stimulation of muscles for the purposes of relaxation of muscle spasms, prevention or retardation of disuse atrophy, increasing local blood circulation, muscle re-education, immediate post-surgical stimulation of calf muscles to prevent venous thrombosis and maintaining or increasing range of motion.
Device Description
The Stim-8 is a compact, battery powered muscle stimulator. It is used to repetitively contract skeletal muscles by providing transcutaneous electrical pulses to areas of the body that require therapy for the indicated medical conditions. The parameters of the Stim-8 cannot be set by the user. Four channels are available on the Stim-8. Each channel operates independently and if desired one, two, three or four channels may be used simultaneously. The only controllable parameters are the amplitude intensity controls of the stimulation.
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