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

    VERI/DFS TM #817

    K Number: K813515 · Decision Jan 19, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    38
    Registration Numbers
    38
    Same Product Code
    60
    Applicant Total
    10
    Review Days
    35

    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
    VERI/DFS TM #817
    K Number
    K813515
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.5810
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Applicant
    Verite
    Date Received
    December 15, 1981
    Decision Date
    January 19, 1982
    Product Code
    GZI
    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
    GZI Stimulator, Neuromuscular, External Functional

    Similar 510(k) Clearances

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

    Synchrony (20-3000)

    FDA 510(k)
    FDA Class 2 ·Neurology

    CIONIC NEURAL SLEEVE (NS-200)

    FDA 510(k)
    FDA Class 2 ·Neurology

    Neuvotion NeuStim NN-01

    FDA 510(k)
    FDA Class 2 ·Neurology

    MyndMove, MyndMove 2.0

    FDA 510(k)
    FDA Class 2 ·Neurology

    EvoWalk 1.0 System

    FDA 510(k)
    FDA Class 2 ·Neurology

    Cionic Neural Sleeve NS-100

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

    Other Clearances by Verite

    K Number Device Name
    K844727 MODEL 1000
    K840099 MODEL 800-A VERI/PPR
    K840098 MODEL 811 VERI/TENS & PO
    K822929 VERIL/PPR PERSONAL PAIN RELIEVER #800
    K820651 MODEL 860-1 VERI/PROBE
    K813108 MODEL 500 VERI/500
    K811351 VERI-FIER
    K810496 VERI/PMS MODEL 815
    K791187 MODEL 810 VERI/TGS