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

    SCHUL-TEC IMMOBILIZER

    K Number: K926291 · Decision Mar 30, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    297
    Registration Numbers
    297
    Same Product Code
    26
    Applicant Total
    1
    Review Days
    106

    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
    SCHUL-TEC IMMOBILIZER
    K Number
    K926291
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    890.3490
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Medical Emergency Support Equipment
    Date Received
    December 14, 1992
    Decision Date
    March 30, 1993
    Product Code
    IQK
    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
    IQK Orthosis, Cervical

    Similar 510(k) Clearances

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

    DORMIE NECK SUPPORT SYSTEM

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    MEDICAL DISPOSABLE BEDDING

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    NOVA PILLOW

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    BATTLE CREEK PILLOW

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    CERVICAL COLLARS & HEAD HALTERS

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    STIFNICK IMMOBILIZING COLLAR

    FDA 510(k)
    FDA Class 1 ·Physical Medicine
    View all