BEUDAMED
    FDA Registration Active 🇨🇳 China

    FDK WRIST CUFF BPM: FT-B31Y

    Reg #: 3008167616 · FEI: 3008167616 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    17
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    FUDAKANG INDUSTRIAL CO LTD
    Registration Number
    3008167616
    FEI Number
    3008167616
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    301,3F,NO.60 BLOCK 1,SHANGSHUXIA RD,, CHANGPING TOWN,
    City
    Dongguan Guangdong
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K150430

    Owner / Operator

    Firm Name
    Fudakang Industrial Co Ltd
    Operator Number
    10031413
    Address
    301,3F, BLOCK 1,NO.60,SHANGSHUXIA ROAD,, CHANGPING TOWN,
    City
    Dongguan
    State
    Guangdong
    Postal Code
    523560
    Country
    CN
    Correspondent
    Bob Yu

    US Agent

    Business Name
    Fudakang Industrial Inc.
    Contact Name
    Jephanie Chen
    Address
    3514 Raina Ridge Ct
    City
    Las Vegas
    State
    NV
    ZIP
    89121
    Country
    US
    Email
    [email protected]
    Phone
    725 7266008

    Products

    Device Name Product Code
    System, Measurement, Blood-Pressure, Non-Invasive DXN

    Proprietary Names

    FDK WRIST CUFF BPM: FT-B31Y Blue Jay Arm & Wrist BPM:FT-C06(BJ120108), FT-B12W(BJ120110) FDK ARM CUFF BPM W/VOICE: FT-C03-V, FT-C03B-V, FT-C11B-V, FT-C12B-V, FT-C15Y-V, FT-C22Y-V, FT-C23Y-V, FT-C24Y-V FDK WRIST CUFF BPM W/BLUETHOTH & UART ( VOICE): FT-B13W-V-BT ChoiceMMed Arm&Wrist BPM: FT-C11B(MDBP12), FT-B12W(BP201) FDK ARM CUFF BPM W/NO VOICE: FT-C11B, FT-C12B, FT-C03B, FT-C15B, FT-C22Y, FT-C23Y, FT-C24Y, FT-C26Y FDK WRIST CUFF BPM W/BLUETHOTH & UART ( NO VOICE): FT-B13W-BT NuvoMed ARM CUFF BPM WITH BLUETOOTH: NBPM-6/0701 (FT-C04B-BT) FDK ARM CUFF BPM W/BLUETHOTH: FT-C11B-BT AUPO WRIST CUFF BPM:FT-B13W Sunbeam Wrist BPM : FT-B06W-V & FT-B06W WOODLANDS ARM CUFF BPM WITH BLUETOOTH: FT-C07B-BT FDK ARM CUFF BLOOD PRESSURE MONITOR: FT-C15B FDK Electronic Blood Pressure Monitor Wrist Type : FT-B14W FDK Electronic Blood Pressure Monitor Arm Type : FT-C15Y FDK Electronic Blood Pressure Monitor Arm Type : FT-C24Y FDK ARM CUFF SPEAKING BLOOD PRESSURE MONITOR: FT-C03-V

    Establishment Types

    Manufacture Medical Device