LogoFDA 510(k) Search
Search Filters

Search Results

Found 3 results

510(k) Data Aggregation

    K Number
    K232230
    Device Name
    YJ-K1/K2 Wheelchair (YJ-K1F 16 NDE; YJ-K1F 16 NDS; YJ-K1F 18 NDE; YJ-K1F 18 NDS; YJ-K1F 20 NDE; YJ-K1F 20 NDS; YJ-K1F 18 NDEE; YJ-K1F 16 VDE; YJ-K1F 16 VDS; YJ-K1F 18 VDE; YJ-K1F 18 VDS; YJ-K1F 20 VDE; YJ-K1F 20 VDS; YJ-K2 16 VDFE; YJ-K2 16 VDFS; YJ-K2 18 VDFE; YJ-K2 18 VDFS; YJ-K2 20 VDFE; YJ-K2 20 VDFS; YJ-K1G 18 NFFE; YJ-K1G 18 NFFS; YJ-K2TC 16 NAFE; YJ-K2TC 18 NAFE; YJ-K2TC 20 NAFE)
    Manufacturer
    Zhenjiang Assure Medical Equipment Co., Ltd.
    Date Cleared
    2023-10-03

    (68 days)

    Product Code
    IOR
    Regulation Number
    890.3850
    Why did this record match?
    Applicant Name (Manufacturer) :

    Zhenjiang Assure Medical Equipment Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The YJ-K1/K2 Manual Wheelchair is to provide mobility to persons limited to a sitting position.
    Device Description
    The YJ- K1,K2 series are mechanical wheelchairs which are a manually operated devices with wheels that are intended for medical purposes to provide mobility to persons restricted to a sitting position. It can be folded for transport by bring the two sides together. The manual wheelchair incorporates a main frame, a seat, two adjustable footrests and four wheels. The larger rear wheels have hand rims of slightly smaller diameter projecting just beyond the tire. These allows the user to manoeuvre the chair by pushing them on without requiring them to grasp the tires. The manual wheelchairs have brakes that bear on the tires of the rear wheels and two push handles at the upper rear of the frame to allow for manual propulsion by an assistant.
    Ask a Question
    K Number
    K232198
    Device Name
    Reclining wheelchair (YJ-011S 16”D, YJ-011S 16”DF, YJ-011S 18”D, YJ-011S 18”DF, YJ-011S 20”D, YJ-011S 20”DF)
    Manufacturer
    Zhenjiang Assure Medical Equipment Co., Ltd.
    Date Cleared
    2023-09-15

    (52 days)

    Product Code
    IOR
    Regulation Number
    890.3850
    Why did this record match?
    Applicant Name (Manufacturer) :

    Zhenjiang Assure Medical Equipment Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The YJ-011S Manual Wheelchair is to provide mobility to persons limited to a sitting position.
    Device Description
    The YJ-011S series is a mechanical wheelchair which is a manually operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position. It can be folded for transport by bringing the two sides together. The manual wheelchair incorporates a main frame, a seat, two adjustable footrests and four wheels. The larger rear wheels have hand rims of slightly smaller diameter projecting just beyond the tire. These allows the user to maneuver the chair by pushing them on without requiring them to grasp the tires. The manual wheelchairs have brakes that bear on the tires of the rear wheels and two push handles at the upper rear of the frame to allow for manual propulsion by an assistant.
    Ask a Question
    K Number
    K232199
    Device Name
    Bariatric Heavy Duty Wheelchair (YJ-010B 20’’DS; YJ-010B 20’’DE; YJ-010B 20’’DFS; YJ-010B 20’’DFE;YJ-010B 20’’ADS; YJ-010B 20’’ADE; YJ-010B 20’’ADFS; YJ-010B 20’’ADFE; YJ-010B 22’’DS; YJ-010B 22’’DE; YJ-010B 22’’DFS;YJ-010B 22’’DFE; YJ-010B 22’’ADS;YJ-010B 22’’ADE; YJ-010B 22’’ADFS; YJ-010B 22’’ADFE; YJ-010B 24’’DS; YJ-010B 24’’DE; YJ-010B 24’’DFS; YJ-010B 24’’DFE; YJ-010B 24’’ADS; YJ-010B 24’’ADE; YJ-010B 22’’ADFS; YJ-010B 24’’ADFE)
    Manufacturer
    Zhenjiang Assure Medical Equipment Co., Ltd.
    Date Cleared
    2023-09-15

    (52 days)

    Product Code
    IOR
    Regulation Number
    890.3850
    Why did this record match?
    Applicant Name (Manufacturer) :

    Zhenjiang Assure Medical Equipment Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The YJ-010B Manual Wheelchair is to provide mobility to persons limited to a sitting position.
    Device Description
    The YJ-010B series is a mechanical wheelchair which is a manually operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position. It can be folded for transport by bringing the two sides together. The manual wheelchair incorporates a main frame, a seat, two adjustable footplates and four wheels. The larger rear wheels have hand rims of slightly smaller diameter projecting just beyond the tire. These allows the user to maneuver the chair by pushing them on without requiring them to grasp the tires. The manual wheelchairs have brakes that bear on the tires of the rear wheels and two push handles at the upper rear of the frame to allow for manual propulsion by an assistant.
    Ask a Question

    Page 1 of 1