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510(k) Data Aggregation
K Number
K031820Device Name
ELECTRONIC MUSCLE MASSAGE, MODELS BE-550 AND BE-660
Manufacturer
Date Cleared
2003-11-12
(153 days)
Product Code
Regulation Number
890.5850Why did this record match?
Applicant Name (Manufacturer) :
MULTINATIONAL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Electrically powered devices intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area.
Indications For Use include:
1. Relaxation of muscle spasms
2. Prevention or retardation of disuse atrophy
3. Increasing local blood circulation
4. Muscle re-education
5. Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
6. Maintaining or increasing range of motion
Device Description
BE-550 is a single-channel battery operated muscle stimulation system. It comprises two main components, namely, an electronic stimulatory module which generates the required stimulation signals, and skin electrodes with lead wires. The product is supplied with a set of single sided adhesive electrodes, an instruction manual, and a set of batteries. Power is derived from three AA cells located in a compartment protected by a removable battery cover. The BE-550 is intended to be used as an electronic muscle stimulator.
BE-660: Is the same as the BE-550 model, but is a two-channel battery operated muscle stimulation system.
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