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510(k) Data Aggregation

    K Number
    K201694
    Device Name
    Air Compression Therapy Device
    Manufacturer
    Shenzhen Dongjilian Electronics Co.,Ltd.
    Date Cleared
    2020-11-19

    (150 days)

    Product Code
    IRP
    Regulation Number
    890.5650
    Why did this record match?
    Applicant Name (Manufacturer) :

    Shenzhen Dongjilian Electronics Co.,Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Air Compression Therapy Device are indicated for the temporary relief of minor muscle aches and for temporary increase in circulation to the treated areas in people who are in good health. The Air Compression Therapy Device simulates kneading and stroking of tissues by using an inflatable garment.
    Device Description
    The Air Compression Therapy Device simulates kneading and stroking of tissues by using an inflatable garment.
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    K Number
    K200354
    Device Name
    Electronic stimulator
    Manufacturer
    Shenzhen Dongjilian Electronics Co.,Ltd.
    Date Cleared
    2020-06-29

    (137 days)

    Product Code
    NUH
    Regulation Number
    882.5890
    Why did this record match?
    Applicant Name (Manufacturer) :

    Shenzhen Dongjilian Electronics Co.,Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back of the neck, arm, lower extremities (leg) and foot due to strain from exercise or normal household work activities by applying current to stimulate nerve.
    Device Description
    Not Found
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    K Number
    K193354
    Device Name
    Air Compression Therapy Device
    Manufacturer
    Shenzhen Dongjilian Electronics Co.,Ltd.
    Date Cleared
    2020-06-08

    (187 days)

    Product Code
    IRP
    Regulation Number
    890.5650
    Why did this record match?
    Applicant Name (Manufacturer) :

    Shenzhen Dongjilian Electronics Co.,Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Air Compression Therapy Device is indicated for the temporary relief of minor muscle aches and for temporary increase in circulation to the treated areas in good health. The Air Compression Therapy Device simulates kneading and stroking of tissues by using an inflatable garment.
    Device Description
    Air Compression Therapy Device consists of an air pump, air pressure sensor, and sleeves working together as one unit. The air pump is connected to the dedicated sleeves via a series of hoses; each sleeve has 3 compression chambers. The compression massage direction is from foot to thigh. By inflating the air chambers sequentially and then deflating as one cycle, the pressure can be adjusted to avoid any discomfort to the patient. The sleeve works under the action of sensor and microprocessor. Software controls the timing and pressure reflected by the sensor, cycling airflow into and out of the sleeves to compress body.
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