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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
    Type
    Traditional
    Panel
    Physical Medicine
    Reference & Predicate Devices
    K030226
    Why did this record match?
    Device Name :

    PainTB, PainTJ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    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.

    AI/ML Overview

    The information provided describes the PainTB/PainTJ Laser systems. Here's a breakdown of the acceptance criteria and study details based on the input:

    1. Table of Acceptance Criteria and Reported Device Performance:

    The document doesn't explicitly list specific numerical acceptance criteria for performance like a certain percentage reduction in pain score with a corresponding confidence interval. Instead, it relies on demonstrating statistical significance in pain reduction compared to a mock device and claiming substantial equivalence to a predicate device.

    Acceptance Criteria (Implied)Reported Device Performance
    SafetyNo adverse effects observed during the clinical study. Complies with general safety, EMC, usability, home healthcare, medical laser equipment, and laser product safety standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-1-11, IEC 60601-2-22, IEC 60825-1). Biological evaluation (cytotoxicity, skin sensitization, skin irritation) meets ISO 10993 standards.
    Effectiveness for Pain Relief (Low-back pain)The difference in VAS scores before and after treatment for Group B (Active Laser + exercise treatment) and Group C (Mock Laser + exercise treatment) was statistically significant (p-value
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