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

    Heat StimPlus

    K Number: K212918 · Decision Dec 13, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    160
    Registration Numbers
    160
    Same Product Code
    227
    Applicant Total
    6
    Review Days
    90

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    Basic Information

    Device Name
    Heat StimPlus
    K Number
    K212918
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.5890
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Famidoc Technology Co., Ltd.
    Date Received
    September 14, 2021
    Decision Date
    December 13, 2021
    Product Code
    NUH
    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
    NUH Stimulator, Nerve, Transcutaneous, Over-The-Counter

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    Other Clearances by Famidoc Technology Co., Ltd.

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    K113010 FDES100(TENS AND EMS STIMULATOR, FDES102(ED402) TENS STIMULATOR
    K113761 INFRARED THERMOMETER
    K072641 DIGITAL ELECTRONIC THERMOMETER, MODEL: FDTH-V0-1 THRU 4.
    K052849 INFRARED THERMOMETER, FDIR-V1