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

    COMPEX SPORT PLUS

    K Number: K083140 · Decision Feb 9, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    191
    Registration Numbers
    191
    Same Product Code
    161
    Applicant Total
    11
    Review Days
    109

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    COMPEX SPORT PLUS
    K Number
    K083140
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.5850
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Chattanooga Group
    Date Received
    October 23, 2008
    Decision Date
    February 9, 2009
    Product Code
    NGX
    Advisory Committee
    Physical Medicine
    Review Advisory Committee
    PM
    Third Party
    N

    Classifications

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

    Product Code Device Name
    NGX Stimulator, Muscle, Powered, For Muscle Conditioning

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (NGX), ordered by most recent decision date.

    Diacore

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    Zionic Pro Max (EMS)

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    CoolTone

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    Portable Electro Stimulation Therapy Device (LGT-2320BE, LGT-2320ME, and LGT-2320SP)

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    Motive™ Muscle Stimulator for Lower Back (OT01-1003)

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    truFlex

    FDA 510(k)
    FDA Class 2 ·Physical Medicine
    View all

    Other Clearances by Chattanooga Group

    K Number Device Name
    K090632 COMPEX REHAB
    K083433 INTELECT SWD 100, MODEL 1600; SENIOR SOLUTIONS SHORTWAVE DIATHERMY, MODEL 1601
    K070425 VITALSTIM EXPERIA
    K053223 TRITON/TRU-TRAC/TX/TRITON DTS TRACTION
    K051938 TRITON/TRU-TRAC/TX TRACTION DEVICES
    K040662 VECTRA GENISYS (MODULE & TRANSPORTABLE) AND INTELECT XT (MODULE & TRANSPORTABLE) LASER SYSTEMS
    K040285 VECTRA TRANSPORTABLE COMBO AND STIM (SPECIALTY LINE DEALERS); INTELECT TRANSPORTABLE COMBO AND STIM (GENERAL LINE DEALER
    K031077 VECTRA EPR SYSTEM AND INTELECT EPR SYSTEM
    K031116 VECTRA (INTELECT) EPR ULTRASOUND
    K023347 VITAL STIM
    Search all 11 clearances from Chattanooga Group →