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

    SCD KNEE IMMOBILIZER

    K Number: K895278 · Decision Nov 30, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    129
    Registration Numbers
    129
    Same Product Code
    349
    Applicant Total
    66
    Review Days
    99

    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
    SCD KNEE IMMOBILIZER
    K Number
    K895278
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.5800
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Kendall Healthcare Products Co. Div.Of Tyco Health
    Date Received
    August 23, 1989
    Decision Date
    November 30, 1989
    Product Code
    JOW
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

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

    Product Code Device Name
    JOW Sleeve, Limb, Compressible

    Similar 510(k) Clearances

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

    Compression Therapy Device (LGT-2202DVT)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    NanoPress 760A-BT (760A-BT)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Bio Arterial Deluxe (IC-BAP-DX)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Sequential Compression System (SCD600)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    VenAir, Sequential Compression System (9P-089000); VenAir, Sequential Compression System (PM01D01 / Calf garment (S)); VenAir, Sequential Compression System (PM01E01 / Calf garment (M)); VenAir, Sequential Compression System (PM01F01 / Calf garment (L)); VenAir, Sequential Compression System (PM01G01 / Thigh garment (S)); VenAir, Sequential Compression System (PM01H01 / Thigh garment (M)); VenAir, Sequential Compression System (PM01I01 / Thigh garment (L)); VenAir, Sequential Compr

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PlasmaFlow X Compression Sleeve Device (XPF0001)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular
    View all

    Other Clearances by Kendall Healthcare Products Co. Div.Of Tyco Health

    K Number Device Name
    K973763 KENDALL CURITY IODOFORM PACKING STRIP
    K973511 KENDALL CURITY PETROLATUM GAUZE
    K973507 KENDALL XEROFORM PETROLATUM DRESSING (6311,6312,6313,6314,6315,6316,6317)
    K973619 KENDALL CURITY NON-ADHERING DRESSING
    K973509 KENDALL CURASORB ZN + MG ALGINATE WOUND DRESSING
    K973546 KENDALL FAST-CATH PRE LUBRICATED URETHRAL CATHETER
    K970266 KENDALL HYDROPHILIC POWDER WOUND DRESSING
    K963446 KENDALL DUAL LUMEN CATHETER
    K964899 KENDALL CURITY URETERAL CATHETER
    K964519 CURITY THORACENTESIS TRAY
    Search all 66 clearances from Kendall Healthcare Products Co. Div.Of Tyco Health →