BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    AR1000 SERIES ULTRASONIC WOUND THERAPY SYSTEM

    K Number: K131096 · Decision May 16, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    8
    Applicant Total
    3
    Review Days
    393

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    Basic Information

    Device Name
    AR1000 SERIES ULTRASONIC WOUND THERAPY SYSTEM
    K Number
    K131096
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4410
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Arobella Medical, LLC
    Date Received
    April 18, 2013
    Decision Date
    May 16, 2014
    Product Code
    NRB
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    NRB Wound Cleaner, Ultrasound

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    Other Clearances by Arobella Medical, LLC

    K Number Device Name
    K091038 AS 1000 ULTRASOUND WOUND THERAPY SYSTEM
    K062544 AR1000 ULTRASONIC WOUND THERAPY SYSTEM