BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    QUICK RELEASE LIMB HOLDER (24442,24442-050,24442-350)

    K Number: K963552 · Decision Nov 22, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    117
    Registration Numbers
    117
    Same Product Code
    133
    Applicant Total
    21
    Review Days
    78

    Basic Information

    Device Name
    QUICK RELEASE LIMB HOLDER (24442,24442-050,24442-350)
    K Number
    K963552
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6760
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    TECNOL MEDICAL PRODUCTS, INC.
    Date Received
    September 5, 1996
    Decision Date
    November 22, 1996
    Product Code
    FMQ
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

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

    Product Code Device Name
    FMQ Restraint, Protective

    Similar 510(k) Clearances

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

    PROTECTIVE RESTRAINT

    FDA 510(k)
    FDA Class 1 ·General Hospital

    STATSTRAP NEONATAL INCUBATOR SAFETY STRAP, MODELS SS-001, SS-002

    FDA 510(k)
    FDA Class 1 ·General Hospital

    CENTURION PROTECTIVE RESTRAINT, SCR SERIES

    FDA 510(k)
    FDA Class 1 ·General Hospital

    COMFORTCARE COMPRESSION SUPPORT WITH MAGNETS COMFORTCARE MAGNETIC INSOLES

    FDA 510(k)
    FDA Class 1 ·General Hospital

    INFANT LIMB HOLDER, MODELS 306080 & 306081

    FDA 510(k)
    FDA Class 1 ·General Hospital

    CINCH-TYPE DISPOSABLE LIMB HOLDERS, MODEL 912025

    FDA 510(k)
    FDA Class 1 ·General Hospital
    View all

    Other Clearances by TECNOL MEDICAL PRODUCTS, INC.

    K Number Device Name
    K974068 PFR95 PARTICULATE FILTER RESPIRATOR AND SURGICAL MASK REGULAR SIZE, PFR95 PARTICULATE FILTER RESPIRATOR AND SURGICAL
    K970448 PCM 2000; ISOLAIR APR MODEL 2735
    K963559 WRPAROUND LIMB HOLDER (24446,24446-350,24447-010,24449-010)
    K963564 PERSONAL LIMB HOLDER (24444-200,300,24444-KIT)
    K963557 SYSTEM 2 ZIPPERED BODY HOLDER, SMALL/MEDIUM 24453-010,24453-020,24453-030
    K963561 ULTRA CARE VEST STYLE BODY HOLDER, SMALL (24455-010,020,030,040,24456-010,020,030,040)
    K963556 SECURE-ALL 1-PIECE BODY HOLDER, SMALL/MEDIUM (24451-010,020,24452-010,020,030)
    K963563 ULTRACARE VEST STYLE BODY HOLDER WITH SAFETY SLEEVES, SMALL(24454-010,020,030,040,015,025,035,045,115,125,135,145)
    K963554 24448-010 SECURE-ALL FINGER CONTROL MITT
    K963773 24457-010 SECURE ALL PELVIC HOLDER/24458-010 SECURE ALL BODY BELT
    Search all 21 clearances from TECNOL MEDICAL PRODUCTS, INC. →