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

    LO-BAK TRAX

    K Number: K110858 · Decision Aug 2, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    205
    Registration Numbers
    205
    Same Product Code
    37
    Applicant Total
    1
    Review Days
    127

    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
    LO-BAK TRAX
    K Number
    K110858
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    888.5850
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Roland F Berthiaume, DC
    Date Received
    March 28, 2011
    Decision Date
    August 2, 2011
    Product Code
    HST
    Advisory Committee
    Orthopedic
    Review Advisory Committee
    NE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    HST Apparatus, Traction, Non-Powered

    Similar 510(k) Clearances

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

    Teeter Manual Inversion Table; Teeter Gravity Boots; Teeter Forward Rotation Decompression Device; Teeter Portable Decompression Device; Teeter Horizontal Decompression Table

    FDA 510(k)
    FDA Class 1 ·Orthopedic

    BACK-ON-TRAC, MODEL 101BOT

    FDA 510(k)
    FDA Class 1 ·Orthopedic

    K AND D HOME TRACT

    FDA 510(k)
    FDA Class 1 ·Orthopedic

    ARTHROSCOPIC SHOULDER HOLDER

    FDA 510(k)
    FDA Class 1 ·Orthopedic

    EXTREMITY ELEVATOR

    FDA 510(k)
    FDA Class 1 ·Orthopedic

    TUPPER TROLLEY

    FDA 510(k)
    FDA Class 1 ·Orthopedic
    View all