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

    H WAVE MUSCLE STIMULATOR

    K Number: K915230 · Decision May 8, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    170
    Registration Numbers
    170
    Same Product Code
    547
    Applicant Total
    6
    Review Days
    170

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    Basic Information

    Device Name
    H WAVE MUSCLE STIMULATOR
    K Number
    K915230
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.5850
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Electronic Waveform Laboratory, Inc.
    Date Received
    November 20, 1991
    Decision Date
    May 8, 1992
    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

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    Other Clearances by Electronic Waveform Laboratory, Inc.

    K Number Device Name
    K103738 H-WAVE
    K081998 H-WAVE SPORT
    K873604 E.W.L. P-TENS/H-WAVE FOR GENERAL DENTISTRY
    K862121 E.W.L. P-TENS/H-WAVE
    K813601 E.W.L. P-TENS MODEL(TENS