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

    E.W.L. P-TENS/H-WAVE

    K Number: K862121 · Decision Jun 17, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7
    Same Product Code
    18
    Applicant Total
    6
    Review Days
    379

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    Basic Information

    Device Name
    E.W.L. P-TENS/H-WAVE
    K Number
    K862121
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.1375
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Applicant
    Electronic Waveform Laboratory, Inc.
    Date Received
    June 3, 1986
    Decision Date
    June 17, 1987
    Product Code
    KZM
    Advisory Committee
    Physical Medicine
    Review Advisory Committee
    DE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    KZM Device, Muscle Monitoring

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    Other Clearances by Electronic Waveform Laboratory, Inc.

    K Number Device Name
    K103738 H-WAVE
    K081998 H-WAVE SPORT
    K915230 H WAVE MUSCLE STIMULATOR
    K873604 E.W.L. P-TENS/H-WAVE FOR GENERAL DENTISTRY
    K813601 E.W.L. P-TENS MODEL(TENS