Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K111514
    Device Name
    SBV2, MULTICHARGER MODEL MC10V2
    Manufacturer
    SLEEP PERFORMANCE D.B.A. FATIGUE SCIENCE
    Date Cleared
    2011-12-16

    (198 days)

    Product Code
    LEL
    Regulation Number
    882.5050
    Why did this record match?
    Applicant Name (Manufacturer) :

    SLEEP PERFORMANCE D.B.A. FATIGUE SCIENCE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SBV2 System is an activity monitor designed and intended for documenting physical movements associated with applications in physiological monitoring. The device's intended use is to analyze limb activity associated with movement during sleep and to extract information about certain sleep parameters from these movements. SBV2 can also be used to assess activity in any instance where quantifiable analysis of physical motion is desirable. The use of SBV2 is indicated for adults 22 years of age and over.
    Device Description
    The SBV2 System is a device that monitors activity. It relies on the measurement and analysis of wrist movements to detect and characterize sleep/wake periods. The device allows some aspects of sleep derived from the analysis of activity to be reported. The SBV2 System is graphically depicted in Figure 1.
    Ask a Question

    Page 1 of 1