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

    Air Compression Recovery System

    K Number: K233536 · Decision Dec 16, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    95
    Registration Numbers
    95
    Same Product Code
    152
    Applicant Total
    2
    Review Days
    43

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    Air Compression Recovery System
    K Number
    K233536
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.5650
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Shenzhen Dongjilian Medical Tech Co., Ltd.
    Date Received
    November 3, 2023
    Decision Date
    December 16, 2023
    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.

    Cryo And Thermo Therapy System

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    Cryo Sport 2.0 (AVA 501)

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    Air Compression Leg Massager (LF-FT001, LF-FT002-1, LF-FT003, LF-FT003-1, LF-FT004-1, LF-FT005-1, LF-FT006-1, LF-FT007, LF-FT008, LF-FT009, LF-FT010, LF-FT011, LF-FT012, LF-FT013, LF-FT014, LF-FT015, LF-FT016, UM-01, UM-02, UM-03, UM-03-1, UM-04-1, UM-05-1, UM-06-1, UM-07, UM-08, UM-09, UM-10, UM-11, UM-12, UM-13, UM-14, UM-15, UM-16, AI-01, AI-02, AI-03, AI-04, AI-05, AI-06, AI01, AI02, AI03, AI-07, AI-08, AI-09, AI-10, AI-11, AI-12, AI-13, AI-14)

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    Air Pressure Therapy System (VU-IPC8M); Air Pressure Therapy System (VU-IPC6M); Air Pressure Therapy System (VU-IPC4X)

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    Hot and Cold Compression System (A02-C-032)

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    Cryopush Cold Compression Device (A02-P-001)

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

    Other Clearances by Shenzhen Dongjilian Medical Tech Co., Ltd.

    K Number Device Name
    K222206 Air Compression Leg Massager (Models: S9036C, S9036B and S9036A)