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

    DUAL CHANNEL TENS, PULSAR REMOTE CONTRL

    K Number: K842888 · Decision Jan 14, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    184
    Registration Numbers
    184
    Same Product Code
    605
    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
    DUAL CHANNEL TENS, PULSAR REMOTE CONTRL
    K Number
    K842888
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.5890
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Applicant
    Cryomedics, Inc.
    Date Received
    July 23, 1984
    Decision Date
    January 14, 1985
    Product Code
    GZJ
    Advisory Committee
    Neurology
    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
    GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief

    Similar 510(k) Clearances

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

    STIMPOD NMS460 Nerve Stimulator

    FDA 510(k)
    FDA Class 2 ·Neurology

    actiTENS mini

    FDA 510(k)
    FDA Class 2 ·Neurology

    CP Relief Wand Rx - TENS/NMES

    FDA 510(k)
    FDA Class 2 ·Neurology

    Unipro (K-UNIPRO-US)

    FDA 510(k)
    FDA Class 2 ·Neurology

    TENSWave

    FDA 510(k)
    FDA Class 2 ·Neurology

    Electrical Neuromuscular Stimulator, Cure Trio

    FDA 510(k)
    FDA Class 2 ·Neurology
    View all

    Other Clearances by Cryomedics, Inc.

    K Number Device Name
    K851152 MC-4000 SURGICAL INSTRUMENTS CARDIOVASCULAR
    K844431 YN CO2 LASER SYSTEM 30W
    K842959 MC-4000 CONSOLE & PROBES
    K842704 MT-700 MT-750 FT-350
    K801730 KRYMED SYSTEM 4001 TILT SCOPE
    K800335 KRYMED LIQUID NITROGEN CRYOJET