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

    ESCOTEK-EST 221 VACUUM UNIT

    K Number: K844387 · Decision May 7, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    170
    Registration Numbers
    170
    Same Product Code
    547
    Applicant Total
    7
    Review Days
    175

    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
    ESCOTEK-EST 221 VACUUM UNIT
    K Number
    K844387
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.5850
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Applicant
    Nor-Am Patient Care Products, Inc.
    Date Received
    November 13, 1984
    Decision Date
    May 7, 1985
    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 Nor-Am Patient Care Products, Inc.

    K Number Device Name
    K900647 SOUTHERN CROSS HI-V4 PULSED HIGH VOLTAGE GALVANIC
    K844389 ESCOTEK EST 210, HIGH VOLTAGE ELECTRO GALVANIC STI
    K844388 ESCOTEK EST 220 INTERFERENCE THERAPY UNIT
    K844390 ESCOTEK-EST 204 MULTI STIM
    K844386 ESCOTEK-EST 301A ULTRA-SONIC UNIT
    K844385 ESCOTEK EST TRAC 401