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

    BMLS16-1

    K Number: K172971 · Decision Jul 8, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    160
    Registration Numbers
    160
    Same Product Code
    227
    Applicant Total
    35
    Review Days
    285

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    Basic Information

    Device Name
    BMLS16-1
    K Number
    K172971
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.5890
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Biomedical Life Systems, Inc.
    Date Received
    September 26, 2017
    Decision Date
    July 8, 2018
    Product Code
    NUH
    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
    NUH Stimulator, Nerve, Transcutaneous, Over-The-Counter

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    Other Clearances by Biomedical Life Systems, Inc.

    K Number Device Name
    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
    K031427 ELECTRO NEUROMUSCULAR STIMULATOR, MODEL BMLS03-1
    Search all 35 clearances from Biomedical Life Systems, Inc. →