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510(k) Data Aggregation

    K Number
    K203337
    Device Name
    PainTB, PainTJ
    Manufacturer
    Ptech Co., Ltd.
    Date Cleared
    2022-02-11

    (456 days)

    Product Code
    NHN
    Regulation Number
    890.5500
    Why did this record match?
    Applicant Name (Manufacturer) :

    Ptech Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Pain TB and Pain TJ Laser systems are indicated for adjunctive use in the temporary relief of low-back pain and wrist pain associated with Carpal Tunnel Syndrome.
    Device Description
    PainTB and PainTJ can be used repeatedly and uses semiconductor lasers to generate three wavelengths of light at 670nm, 830nm and 910nm. In general, this device irradiates to the pain area with a laser beam to relieve pain. It can also be controlled via a dedicated app on your smartphone, allowing you to monitor when and how much you have used it.
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