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510(k) Data Aggregation

    K Number
    K252273

    Validate with FDA (Live)

    Device Name
    Therapy US
    Date Cleared
    2025-12-12

    (143 days)

    Product Code
    Regulation Number
    890.5500
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    Device Description
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    K Number
    K252154

    Validate with FDA (Live)

    Date Cleared
    2025-12-09

    (153 days)

    Product Code
    Regulation Number
    890.5850
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K252862

    Validate with FDA (Live)

    Date Cleared
    2025-12-08

    (90 days)

    Product Code
    Regulation Number
    890.3860
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K252825

    Validate with FDA (Live)

    Date Cleared
    2025-12-05

    (91 days)

    Product Code
    Regulation Number
    890.3850
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K252494

    Validate with FDA (Live)

    Date Cleared
    2025-12-05

    (119 days)

    Product Code
    Regulation Number
    890.3860
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K252828

    Validate with FDA (Live)

    Date Cleared
    2025-12-05

    (91 days)

    Product Code
    Regulation Number
    890.3850
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K252588

    Validate with FDA (Live)

    Date Cleared
    2025-12-04

    (111 days)

    Product Code
    Regulation Number
    890.3800
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K250896

    Validate with FDA (Live)

    Device Name
    Aura Wave
    Manufacturer
    Date Cleared
    2025-12-02

    (252 days)

    Product Code
    Regulation Number
    890.5850
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K252590

    Validate with FDA (Live)

    Date Cleared
    2025-11-21

    (98 days)

    Product Code
    Regulation Number
    890.3800
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Powered Mobility scooter is intended for medical purposes to provide mobility to persons restricted to a sitting position.

    Device Description

    The Powered Mobility Scooter, Model PMS105, GUT177, GCAT047 is mainly composed of frame, two front wheel, two drive wheel, control system, motor and drive device, armrest, backrest, seat cushion, pedal, battery and charger. The traveling speed is controlled by the motor, and the traveling direction is manually controlled by the accompanying personnel or passengers. The device is installed with an electromagnetic brake that will engage automatically when the scooter is not in use and the brake cannot be used manually. The Scooter only can be operated on the flat road. When encountering an obstacle in front, please make a detour to avoid the danger of overturning the scooter. It has a driving range of 9.2 km between charges. It is capable of carrying a driver weighing up to 150kg.

    AI/ML Overview

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    K Number
    K252687

    Validate with FDA (Live)

    Date Cleared
    2025-11-21

    (87 days)

    Product Code
    Regulation Number
    890.3850
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The manual wheelchair is to provide mobility to persons limited to a sitting position.

    Device Description

    Manual Wheelchair (HM305-Air1, HM305-Air2)

    AI/ML Overview

    N/A

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