BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    Massage Compression Boots

    K Number: K201645 · Decision Sep 15, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    95
    Registration Numbers
    95
    Same Product Code
    152
    Applicant Total
    9
    Review Days
    90

    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
    Massage Compression Boots
    K Number
    K201645
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.5650
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Jkh USA, LLC
    Date Received
    June 17, 2020
    Decision Date
    September 15, 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.

    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 Jkh USA, LLC

    K Number Device Name
    K203636 PlusCare Temperature Probes, Skin Types: PT2252-AS, PTHP-AS, PTMQ-AS, PTSW-AS, PTSM-15AS, PTSL-AS, PTMR-AS; Rectum Types: PT2252-AG, PTHP-AG, PTMQ-AG, PTSW-AG, PTSM-15AG, PTSL-AG, PTMR-AG
    K203635 Patient Monitoring Cables
    K203652 Blood Pressure Cuff, U1883S,U1883D, U1882S, U1882D, U1881S, U1881D, Blood Pressure Cuff, U1885S, U1885D, U1880S, U1880D, U1886S, U1886D, Blood Pressure Cuff, U1869S, U1869D, U1889S, U1889D, U1884S, U1884D, Blood Pressure Cuff, U1710S, U1720S, U1730S,U1740S, U1750S, U1760S, Blood Pressure Cuff, U1770S, U1790s, U1710D, U1720D, U1730D, U1740D
    K202851 Spo2 Sensor
    K201470 Disposable Medical Face Mask
    K182671 Medi-Direct TENS Pen
    K191151 JKH Stimulator Plus
    K182203 JKH Stimulator Plus