BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    OW100S (model OW100S-US)

    K Number: K213120 · Decision Oct 12, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    783
    Registration Numbers
    783
    Same Product Code
    99
    Applicant Total
    1
    Review Days
    380

    Basic Information

    Device Name
    OW100S (model OW100S-US)
    K Number
    K213120
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    890.5660
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Tissue Regeneration Technologies, LLC DBA as SoftWave TRT
    Date Received
    September 27, 2021
    Decision Date
    October 12, 2022
    Product Code
    ISA
    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
    ISA Massager, Therapeutic, Electric

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