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

    Air Compression Therapy Device

    K Number: K193354 · Decision Jun 8, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    91
    Registration Numbers
    91
    Same Product Code
    138
    Applicant Total
    3
    Review Days
    187

    Basic Information

    Device Name
    Air Compression Therapy Device
    K Number
    K193354
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.5650
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Shenzhen Dongjilian Electronics Co.,Ltd.
    Date Received
    December 4, 2019
    Decision Date
    June 8, 2020
    Product Code
    IRP
    Advisory Committee
    Physical Medicine
    Review Advisory Committee
    PM
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    IRP Massager, Powered Inflatable Tube

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (IRP), ordered by most recent decision date.

    ZT Clinic (MG675A); ZT Cube (ZC3) (MG465A); Z-ONE (MG455A)

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    Air Compression Leg Massager (UM605, UM606, UM607, UM608,UM609,UM610, UM611, UM617)

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    Air Compression Leg Massager (K-705)

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    Air compression massager (ACM-PLUS-A1, ACM-PLUS-A2, ACM-PLUS-A3, ACM-PLUS-A4, ACM-PLUS-A5, ACM-PLUS-A6)

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    Game Ready system (550500-04); Game Ready Control Unit (550550-04); Game Ready Full Leg Boot Wrap - Medium (590923-04); Game Ready Full Leg Boot Wrap - Large (590922-04); Game Ready C-T Spine Wrap (590502-04); Game Ready Half Leg Boot (590906-04); Game Ready Back Wrap (590500-04); Game Ready Hand/Wrist Wrap (590811-04); Game Ready Flexed Elbow Wrap (590903-04); Game Ready Straight Elbow Wrap (590200-04); Game Ready Shoulder Wrap, Medium, Right (590422-04); Game Ready Shoulder Wrap, La

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    Air Pressure Therapy System

    FDA 510(k)
    FDA Class 2 ·Physical Medicine
    View all

    Other Clearances by Shenzhen Dongjilian Electronics Co.,Ltd.

    K Number Device Name
    K201694 Air Compression Therapy Device
    K200354 Electronic stimulator