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

    INFLATABLE FULL LEG SPLINT

    K Number: K874051 · Decision Nov 23, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    51
    Registration Numbers
    51
    Same Product Code
    6
    Applicant Total
    5
    Review Days
    49

    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
    INFLATABLE FULL LEG SPLINT
    K Number
    K874051
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.3900
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Vinyl Technology, Inc.
    Date Received
    October 5, 1987
    Decision Date
    November 23, 1987
    Product Code
    FZF
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    FZF Splint, Extremity, Inflatable, External

    Similar 510(k) Clearances

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

    COMPRESAID

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    INFLATABLE HALF LEG SPLINT

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    INFLATABLE FOOT & ANKLE SPLINT

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    INFLATABLE FULL ARM SPLINT

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    INFLATABLE AIR SPLINTS

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    URIAS PRESSURE SPLINTS, & FIRST AID

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery
    View all

    Other Clearances by Vinyl Technology, Inc.

    K Number Device Name
    K874774 TROUSERS, PNEUMATIC, ANTI-SHOCK THREE BLADDERS
    K874052 INFLATABLE HALF LEG SPLINT
    K874050 INFLATABLE FOOT & ANKLE SPLINT
    K874053 INFLATABLE FULL ARM SPLINT