BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    PRIZM MEDICAL, INC. MICRO-Z STIMULATION SYSTEM

    K Number: K024181 · Decision Jun 26, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    170
    Registration Numbers
    170
    Same Product Code
    547
    Applicant Total
    8
    Review Days
    189

    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
    PRIZM MEDICAL, INC. MICRO-Z STIMULATION SYSTEM
    K Number
    K024181
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.5850
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Prizm Medical, Inc.
    Date Received
    December 19, 2002
    Decision Date
    June 26, 2003
    Product Code
    IPF
    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
    IPF Stimulator, Muscle, Powered

    Similar 510(k) Clearances

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

    Apollo Quattro (APQ-10M)

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    High Tone Power therapy (HiToP) (Model: HiToP PNP)

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    StimelMD (SSMD) system

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    Compact II

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    EVE Synergy (EVE-20M)

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    TrainFES Advance

    FDA 510(k)
    FDA Class 2 ·Physical Medicine
    View all

    Other Clearances by Prizm Medical, Inc.

    K Number Device Name
    K133502 5000Z FIREFLY SYSTEM
    K033122 5000Z SYSTEM (OTC)
    K032239 THERA-CREAM, MODEL TCT004
    K012974 PRIZM MEDICAL INC. THERMOTRACE INFRARED THERMOMETER MODELS 15004 AND 15007
    K951727 Z-WATCH SYSTEM
    K944487 ELECTRO-MESH SOCK, WRAP, AND SLEEVE ELECTRODES
    K932299 ELECTRO-MESH