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

    KINESTHETIC ABILITY TRAINER (K.A.T., MODEL 1000)

    K Number: K911795 · Decision Nov 19, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    21
    Applicant Total
    16
    Review Days
    211

    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
    KINESTHETIC ABILITY TRAINER (K.A.T., MODEL 1000)
    K Number
    K911795
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Breg, Inc.
    Date Received
    April 22, 1991
    Decision Date
    November 19, 1991
    Product Code
    LXV
    Advisory Committee
    Unknown
    Review Advisory Committee
    EN
    Third Party
    N

    Classifications

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

    Product Code Device Name
    LXV Apparatus, Vestibular Analysis

    Similar 510(k) Clearances

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

    GyroStim

    FDA 510(k)
    FDA Unclassified ·Unknown

    Orion

    FDA 510(k)
    FDA Unclassified ·Unknown

    TRV

    FDA 510(k)
    FDA Unclassified ·Unknown

    ClearEdge Balance System

    FDA 510(k)
    FDA Unclassified ·Unknown

    EQ Balance

    FDA 510(k)
    FDA Unclassified ·Unknown

    K-D Balance

    FDA 510(k)
    FDA Unclassified ·Unknown
    View all

    Other Clearances by Breg, Inc.

    K Number Device Name
    K183702 Polar Care Wave
    K070402 MODIFICATION TO POLAR CARE 500
    K041714 E-PAIN CARE
    K020988 PAIN CARE 4200
    K013928 PAIN CARE 3200
    K003611 PAIN CARE MULTI-PORT CATHETER, MODEL 2000L
    K002073 PAIN CARE 3000
    K002321 PAIN CARE 2000L
    K983454 PAIN CARE 2000
    K963596 POLAR CARE 300
    Search all 16 clearances from Breg, Inc. →