BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇳 China

    MStim Drop Model: LGT-233

    K Number: K202110 · Decision Nov 5, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    38
    Registration Numbers
    38
    Same Product Code
    60
    Applicant Total
    6
    Review Days
    463

    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
    MStim Drop Model: LGT-233
    K Number
    K202110
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.5810
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Guangzhou Longest Science & Technology Co., Ltd.
    Date Received
    July 30, 2020
    Decision Date
    November 5, 2021
    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 Guangzhou Longest Science & Technology Co., Ltd.

    K Number Device Name
    K201845 Portable Electro-Stimulation Therapy Device, Model: LGT-232(US)
    K182020 Portable Electro-Stimulation Therapy Device
    K191856 Compression Therapy Device
    K191862 Compression Therapy Device Model LGT-2200SP
    K182108 Portable Electro-Stimulation Therapy Device