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

    GALVANIC GENERATOR MODEL IMF4150/A

    K Number: K932916 · Decision Jan 7, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    170
    Registration Numbers
    170
    Same Product Code
    547
    Applicant Total
    35
    Review Days
    205

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    Basic Information

    Device Name
    GALVANIC GENERATOR MODEL IMF4150/A
    K Number
    K932916
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.5850
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Biomedical Life Systems, Inc.
    Date Received
    June 16, 1993
    Decision Date
    January 7, 1994
    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 Biomedical Life Systems, Inc.

    K Number Device Name
    K172971 BMLS16-1
    K102051 PAIN BUDDY
    K061476 ELECTRO-NERVE STIMULATOR TENS, MODEL BMLS06-1
    K042711 MODEL BMLS03-7
    K041388 COMBINATION POWERED ELECTRICAL MUSCLE STIMULATOR AND INTERFERENTIAL STIMULATOR, MODEL BMLS04-1
    K040007 INTERFERENTIAL STIMULATOR, MODEL BMLS02-6
    K033174 BMLS03-3
    K040824 INTERFERENTIAL STIMULATOR, MODEL BMLS03-6
    K040306 HIGH VOLTAGE PULSED STIMULATOR, MODEL BMLS02-7
    K033455 ELECTRO-NERVE STIMULATOR TENS, MODEL BMLS03-5
    Search all 35 clearances from Biomedical Life Systems, Inc. →