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

    Devon 52 Sequential Compression Device

    K Number: K182150 · Decision Dec 18, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    129
    Registration Numbers
    129
    Same Product Code
    349
    Applicant Total
    6
    Review Days
    132

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    Basic Information

    Device Name
    Devon 52 Sequential Compression Device
    K Number
    K182150
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.5800
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Devon Medical Products (Jiangsu), Ltd.
    Date Received
    August 8, 2018
    Decision Date
    December 18, 2018
    Product Code
    JOW
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

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

    Product Code Device Name
    JOW Sleeve, Limb, Compressible

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    Other Clearances by Devon Medical Products (Jiangsu), Ltd.

    K Number Device Name
    K190423 Devon 24D Deep Vein Thrombosis (DVT) Prevention Therapy System
    K182578 Devon 62 Deep Vein Thrombosis (DVT) Prevention Therapy Device
    K173528 Devon 24R Deep Vein Thrombosis (DVT) Prevention Therapy System
    K172030 Devon 51
    K170814 Devon 24