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

    Pain Therapy Device(Model: DH-P.T.S-I, DH-P.T.S-II, DH-P.T.S-IIA, DH-P.T.S-IIB, DH-CP-I)

    K Number: K212948 · Decision Nov 1, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    191
    Registration Numbers
    191
    Same Product Code
    161
    Applicant Total
    12
    Review Days
    46

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    Basic Information

    Device Name
    Pain Therapy Device(Model: DH-P.T.S-I, DH-P.T.S-II, DH-P.T.S-IIA, DH-P.T.S-IIB, DH-CP-I)
    K Number
    K212948
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.5850
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Guangzhou Xinbo Electronic Co., Ltd.
    Date Received
    September 16, 2021
    Decision Date
    November 1, 2021
    Product Code
    NGX
    Advisory Committee
    Physical Medicine
    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
    NGX Stimulator, Muscle, Powered, For Muscle Conditioning

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    Other Clearances by Guangzhou Xinbo Electronic Co., Ltd.

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    K200402 DR-HO'S Electro Therapy Conductive Gel
    K190118 Dr-Ho's Foot Pad Electrode (Models: DHFRE-I, CP-I, CP-II, CP-III)
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    Search all 12 clearances from Guangzhou Xinbo Electronic Co., Ltd. →