BEUDAMED
    FDA Registration Active 🇨🇳 China

    FOOTREST, COMPLETE - PMT XD

    Reg #: 3003781173 · FEI: 3003781173 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    26
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    ZHONGSHAN A&E MACHINERY INDUSTRY CO., LTD
    Registration Number
    3003781173
    FEI Number
    3003781173
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    No 4 and No 8 Plants 9 Shenghui South Road, Nantou Town
    City
    Zhongshan City Guangdong
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K052586

    Owner / Operator

    Firm Name
    Zhongshan A&E Machinery Industry Co., LTD
    Operator Number
    10049449
    Address
    No 4 and No 8 Plants 9 Shenghui South Rd, Nantou Town
    City
    Zhongshan City
    State
    Guangdong
    Postal Code
    510000
    Country
    CN

    US Agent

    Business Name
    Regulatory Insight, Inc.
    Contact Name
    Kevin Walls
    Address
    33 Golden Eagle Lane
    City
    Littleton
    State
    CO
    ZIP
    80127
    Country
    US
    Email
    [email protected]
    Phone
    720 9625412

    Products

    Device Name Product Code
    Wheelchair, Mechanical IOR

    Proprietary Names

    FOOTREST, COMPLETE - PMT XD ANTI-TIPPER PR, PARAMOUNT XD SEAT UPH,BLK NYLN 30X18-PMT XD ELR BLACK PANEL - PMT XD W/C PARAMOUNT XD 26W DSK SWF BACK UPH,BLK NYLON 26W-PMT XD AXLE,NUT&WASHER(10EA) PMT XD MEDICHOICE BARI WC 30W DSK SWF BACK UPH,BLK NYLON 30W-PMT XD W/C PARAMOUNT XD 30W DSK SWF ANTI-FOLDING BAR, CHROMED (LOWER FRAME) W/C PARAMOUNT XD 30W DSK ELR ARM PAD, DSK - PMT XD WHL LOCK,PUSH TO LOCK-PMT XD MEDICHOICE BARI WC 30W DSK ELR ARMS,DETACH DSK - PMT XD GRIP(10EACH) PMT XD WHL LOCK EXTENSION - PMT XD RPL KNOBS PLASTIC-PMT XD MEDICHOICE BARI WC 26W DSK ELR POSITIONING BELT - PMT XD SEAT UPH,BLK NYLN 26X18-PMT XD REAR WHL, 24" - PMT XD LEGREST, COMPLETE - PMT XD MEDICHOICE BARI WC 26W DSK SWF W/C PARAMOUNT XD 26W DSK ELR

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device