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Dateline: Jan 27th 2005
The US FDA has allowed the marketing of the Biomove 3000. In the FDA's 510K listing, they have shown it as substantially equivalent to the Neuromove NM900 device being marketed by another company.
The following information has been excerpted from the FDA 510K Summary Document dated Jan-27-05 number K-042650.
The FDA states that the Biomove 3000 is a portable, battery powered EMG triggered neuromuscular electrical stimulator device used as a training system for the rehabilitation of paralyzed muscles, mainly after a stroke.
The controls of the device are simple to operate. It has two main control knobs: one to set the gain of the EMG amplifier (sensitivity for picking up the residual electrical muscle signal) and one to set the stimulation level for the stimulation impulse to the muscles to be re-educated.
The following parts are supplied with the system: 3-lead Patient Cable, re-usable electrodes (Biotrodes) and a belt for fastening the device to the body of the user. A 5-lead Patient Cable is optional.
In the FDA listing it is stated that the Biomove 3000 is indicated for:
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Stroke Rehabilitation by Muscle Re-education
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Prevention or retardation of disuse atrophy
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Increasing local blood circulation
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Muscle re-education
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Maintaining or increasing range of motion
The Biomove 3000 complies with the US Federal Performance Standard as set forth in 21 CFR 898 for electrode lead wires and patient cables.
Here is the direct link to the listing for the Biomove 3000 at the FDA website.
See http://www.fda.gov/cdrh/pdf4/k042650.pdf.
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