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

    THERAPACER 3000

    K Number: K925666 · Decision Mar 9, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    113
    Registration Numbers
    113
    Same Product Code
    159
    Applicant Total
    5
    Review Days
    119

    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
    THERAPACER 3000
    K Number
    K925666
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    890.5380
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Kvm Technologies, Inc.
    Date Received
    November 10, 1992
    Decision Date
    March 9, 1993
    Product Code
    BXB
    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
    BXB Exerciser, Powered

    Similar 510(k) Clearances

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

    G-TRAINER MEDICAL

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    FLO-BOOT

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    ANKLE CALF EXERCISER PHLEBOPUMP

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    E-Z FLEX

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    BTE CPM-20

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    BTE CPM-10

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

    Other Clearances by Kvm Technologies, Inc.

    K Number Device Name
    K883989 KVM ISOTONIC FLUSH SOLUTION
    K883990 KVM ISOTONIC DILUENT
    K883992 KVM PREPACK HEMATOLOGY REAGENT SET
    K883991 KVM HEMOGLOBIN LYSING REAGENT