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

    H-WAVE SPORT

    K Number: K081998 · Decision Jul 9, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    191
    Registration Numbers
    191
    Same Product Code
    161
    Applicant Total
    6
    Review Days
    360

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    Basic Information

    Device Name
    H-WAVE SPORT
    K Number
    K081998
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.5850
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Electronic Waveform Laboratory, Inc.
    Date Received
    July 14, 2008
    Decision Date
    July 9, 2009
    Product Code
    NGX
    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
    NGX Stimulator, Muscle, Powered, For Muscle Conditioning

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    Other Clearances by Electronic Waveform Laboratory, Inc.

    K Number Device Name
    K103738 H-WAVE
    K915230 H WAVE MUSCLE STIMULATOR
    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