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

    RS-4M+MUSCLE STIMULATOR

    K Number: K000114 · Decision Aug 10, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    170
    Registration Numbers
    170
    Same Product Code
    547
    Applicant Total
    10
    Review Days
    209

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    Basic Information

    Device Name
    RS-4M+MUSCLE STIMULATOR
    K Number
    K000114
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.5850
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Rs Medical
    Date Received
    January 14, 2000
    Decision Date
    August 10, 2000
    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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    K062325 RS-4I MUSCLE STIMULATOR FAMILY
    K032652 RS-4I MUSCLE STIMULATOR FAMILY
    K021763 RS2MI MUSCLE STIMULATOR FAMILY
    K990697 RS-4V MUSCLE STIMULATOR
    K953136 RS-4M
    K920388 RS-1 NEUROMUSCULAR STIMULATOR
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