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

    DR-HO's Back Pain Relief System Pro (Models BPRS-I and BPRS-II)

    K Number: K202671 · Decision Nov 12, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    160
    Registration Numbers
    160
    Same Product Code
    227
    Applicant Total
    12
    Review Days
    424

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    Basic Information

    Device Name
    DR-HO's Back Pain Relief System Pro (Models BPRS-I and BPRS-II)
    K Number
    K202671
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.5890
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Guangzhou Xinbo Electronic Co., Ltd.
    Date Received
    September 14, 2020
    Decision Date
    November 12, 2021
    Product Code
    NUH
    Advisory Committee
    Neurology
    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
    NUH Stimulator, Nerve, Transcutaneous, Over-The-Counter

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