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

    DYNATRON PELTIER THERMOSTIM PROBE

    K Number: K132057 · Decision Jan 24, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    243
    Registration Numbers
    243
    Same Product Code
    436
    Applicant Total
    24
    Review Days
    205

    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
    DYNATRON PELTIER THERMOSTIM PROBE
    K Number
    K132057
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.1320
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Dynatronics Corp.
    Date Received
    July 3, 2013
    Decision Date
    January 24, 2014
    Product Code
    GXY
    Advisory Committee
    Neurology
    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
    GXY Electrode, Cutaneous

    Similar 510(k) Clearances

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

    BioWave BioWraps

    FDA 510(k)
    FDA Class 2 ·Neurology

    Elde Medical Electrodes (T5/ 5 cm x 5cm electrode T10/ 5 cm x 10cm electrode)

    FDA 510(k)
    FDA Class 2 ·Neurology

    MR Conditional Cup Electrodes

    FDA 510(k)
    FDA Class 2 ·Neurology

    Tutamen Self Adhesive Electrodes

    FDA 510(k)
    FDA Class 2 ·Neurology

    myosmart. (13E522); myosmart.cuff (757M20-2); connectgrip. (560X27-1); myosmart trial kit (642V64=T)

    FDA 510(k)
    FDA Class 2 ·Neurology

    Ceribell Brain Monitor Headband

    FDA 510(k)
    FDA Class 2 ·Neurology
    View all

    Other Clearances by Dynatronics Corp.

    K Number Device Name
    K113250 DYNATRON TRI-WAVE LIGHT PAD DYNATRON TRI-WAVE LIGHT PROBE
    K060814 DYNATRON ION IONTOPHORESIS ELECTRODE
    K051680 DYNATRON DX2 TRACTION UNIT
    K051261 DYNATRON X3 , DYNATRON XP IR LIGHT PAD, D405 IR LIGHT PROBE
    K043047 DYNATRON IBOX IONTOPHORESIS DEVICE
    K040729 SOLARIS D890 THERAPY PROBE
    K031329 DYNATRON SOLARIS SERIES, MODELS 705, 706, 708, 709 D880 INFRARED PROBE (OPTIONAL ACCESSORY)
    K010948 DYNATRON STS RX
    K010565 DYNATRON STS
    K993919 DYNATRON 900
    Search all 24 clearances from Dynatronics Corp. →