BEUDAMED
    FDA 510(k) FDA class 1 Unknown 🇺🇸 United States

    RESTLESS LEG DEVICE

    K Number: DEN110009 · Decision Dec 18, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    0
    Applicant Total
    1
    Review Days
    1056

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    Basic Information

    Device Name
    RESTLESS LEG DEVICE
    K Number
    DEN110009
    Device Class
    FDA class 1
    Clearance Type
    Post-NSE
    Regulation Number
    890.5760
    Medical Specialty
    Physical Medicine
    Decision
    Unknown
    Applicant
    Mary M. Sorg (An Individual) Dba PJ Sleeper'S
    Date Received
    January 27, 2011
    Decision Date
    December 18, 2013
    Product Code
    OTX
    Advisory Committee
    Physical Medicine
    Review Advisory Committee
    NE
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    OTX Foot Wrap For Treating Restless Leg Syndrome Symptoms