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

    RS-4M

    K Number: K953136 · Decision Nov 30, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    170
    Registration Numbers
    170
    Same Product Code
    547
    Applicant Total
    10
    Review Days
    147

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    Basic Information

    Device Name
    RS-4M
    K Number
    K953136
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.5850
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent for Some Indications
    Applicant
    Rs Medical
    Date Received
    July 6, 1995
    Decision Date
    November 30, 1995
    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 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
    K062325 RS-4I MUSCLE STIMULATOR FAMILY
    K032652 RS-4I MUSCLE STIMULATOR FAMILY
    K021763 RS2MI MUSCLE STIMULATOR FAMILY
    K000114 RS-4M+MUSCLE STIMULATOR
    K990697 RS-4V MUSCLE STIMULATOR
    K920388 RS-1 NEUROMUSCULAR STIMULATOR
    K920389 RS-2 NEUROMUSCULAR STIMULATOR