BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇰🇷 South Korea

    HANAROCare ReJu

    K Number: K160893 · Decision Jul 27, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    160
    Registration Numbers
    160
    Same Product Code
    227
    Applicant Total
    14
    Review Days
    118

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    HANAROCare ReJu
    K Number
    K160893
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.5890
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    M.I.Tech Co., Ltd.
    Date Received
    March 31, 2016
    Decision Date
    July 27, 2016
    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

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (NUH), ordered by most recent decision date.

    TENS / EMS DEVICE (FT-247 Series) (FT-247, FT-237)

    FDA 510(k)
    FDA Class 2 ·Neurology

    TENS/EMS device (GUSE01)

    FDA 510(k)
    FDA Class 2 ·Neurology

    TENS AND EMS (TENS and Muscle Stimulator) (JT1065, JT1080, JT2080, JT9034)

    FDA 510(k)
    FDA Class 2 ·Neurology

    TENS&EMS (HZ9151B, HZ9151C, HZ9151D)

    FDA 510(k)
    FDA Class 2 ·Neurology

    VEINOPLUS Back

    FDA 510(k)
    FDA Class 2 ·Neurology

    Transcutaneous Electrical Nerve Stimulator (RJTENS-2)

    FDA 510(k)
    FDA Class 2 ·Neurology
    View all

    Other Clearances by M.I.Tech Co., Ltd.

    K Number Device Name
    K253327 HANAROSTENT Esophagus Upper (CCC)
    K213251 HANAROSTENT Esophagus Asymmetric (CCC)
    K201160 HANAROSTENT Esophagus (CCC), HANAROSTENT Esophagus (NCN)
    K202973 HANAROSTENT Benefit Biliary (NNN)
    K201342 HANAROSTENT Trachea/Bronchium (CCC)
    K200860 HANAROSTENT Esophagus TTS (CCC), HANAROSTENT Esophagus TTS (NCN)
    K190141 HANAROSTENT LowAx Colon/Rectum (NNN)
    K183396 HANAROSTENT FASTTM Biliary (NNN)
    K183616 HANAROSTENT LowAx Colon/Rectum (NNN), HANAROSTENT LowAx Duodenum/Pylorus (NNN)
    K180180 HANAROSTENT LowAxTM Colon/Rectum (NNN), HANAROSTENT LowAxTM Duodenum/Pylorus (NNN)
    Search all 14 clearances from M.I.Tech Co., Ltd. →