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

    RS-4I MUSCLE STIMULATOR FAMILY

    K Number: K062325 · Decision Apr 13, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    66
    Registration Numbers
    66
    Same Product Code
    7
    Applicant Total
    10
    Review Days
    247

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    Basic Information

    Device Name
    RS-4I MUSCLE STIMULATOR FAMILY
    K Number
    K062325
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.5890
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Rs Medical
    Date Received
    August 9, 2006
    Decision Date
    April 13, 2007
    Product Code
    NYN
    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
    NYN Stimulator, Electrical, Transcutaneous, For Arthritis

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    Other Clearances by Rs Medical

    K Number Device Name
    K112348 RS-4I MUSCLE STIMULATOR
    K090951 RS- LB LOW BACK CONDUCTIVE GARMENT, MODEL RS-LBM, RS-LBL, RS-FBG FULL BACK CONDUCTIVE GARMENT , MODEL RS-FBG
    K032652 RS-4I MUSCLE STIMULATOR FAMILY
    K021763 RS2MI MUSCLE STIMULATOR FAMILY
    K000114 RS-4M+MUSCLE STIMULATOR
    K990697 RS-4V MUSCLE STIMULATOR
    K953136 RS-4M
    K920388 RS-1 NEUROMUSCULAR STIMULATOR
    K920389 RS-2 NEUROMUSCULAR STIMULATOR