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510(k) Data Aggregation
K Number
K080787Device Name
BIOMOVE 5000 SYSTEM
Manufacturer
Date Cleared
2008-04-17
(28 days)
Product Code
Regulation Number
890.5850Why did this record match?
Applicant Name (Manufacturer) :
CURATRONIC, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Biomove 5000 is indicated for:
1. Stroke Rehabilitation by Muscle Re-education
2. Prevention of retardation of disuse atrophy
3. Increasing local blood circulation
4. Muscle re-education
5. Maintaining or increasing range of motion
Device Description
The Biomove 5000 is a powered EMG triggered neuromuscular electrical stimulator device used as a training system for rehabilitation of paralyzed muscles, mainly after stroke. The following accessories are supplied with the system: Patient Cable, re-usable electrodes (Biotrodes).
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K Number
K042650Device Name
BIOMOVE 3000
Manufacturer
Date Cleared
2005-01-27
(121 days)
Product Code
Regulation Number
890.5850Why did this record match?
Applicant Name (Manufacturer) :
CURATRONIC, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Biomove 3000 is indicated for:
1. Stroke Rehabilitation by Muscle Re-education
2. Prevention or retardation of disuse atrophy
3. Increasing local blood circulation
4. Muscle re-education
5. Maintaining or increasing range of motion
Device Description
The Biomove 3000 is a portable, battery powered EMG triggered neuromuscular electrical stimulator device used as a training system for rehabilitation of paralyzed muscles, mainly after stroke. The controls of the device are simple to operate. It has only 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 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.
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