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510(k) Data Aggregation

    K Number
    K172733
    Device Name
    TD-1035 Thermometer
    Manufacturer
    TaiDoc Technology Corporation
    Date Cleared
    2018-10-22

    (406 days)

    Product Code
    FLL
    Regulation Number
    880.2910
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    K152680
    Why did this record match?
    Reference Devices :

    K152680

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    TD-1035 Thermometer is a temperature detector which is intended to measure the body temperature on axillary region. The device is intended for population age of six months and above, which is designed for home use.

    Device Description

    TD-1035 Thermometer is a temperature detector which is intended to measure the body temperature on axillary region, and transmit data to personnel device via Bluetooth pairing. The design concept is equivalent to the predicate device, K152680. There are two modifications made to the subject device: (1) indication for use (2) an elastic band was added. The elastic band is designed for more suitable and comfortable wearing. Moreover, the detected sensor contacts user skin directly, which is located on the silicone belt. The parts that contact the user are: (1) elastic band (2) sensor head (3) silicone belt.

    AI/ML Overview

    The device in question is the TaiDoc TD-1035 Thermometer, intended for measuring body temperature in the axillary region for individuals aged six months and above, designed for home use.

    Here's an analysis of the acceptance criteria and the studies performed:

    1. Table of Acceptance Criteria and Reported Device Performance

    Test CategoryAttachmentStandardAcceptance CriteriaReported Device Performance
    SoftwareA1.1IEC 62304Safety and effectiveness of software meet the device's indications for use.PASS
    Electrical Safety & PerformanceA1.2IEC 60601-1Basic safety and essential performance of medical electrical equipment and systems.PASS
    A1.3IEC 60601-1-11Basic safety and essential performance of medical electrical equipment and systems for use in the home healthcare environment.PASS
    A1.4IEC 60601-1-2Maintain Essential Performance and Basic Safety of EMC requirements when exposed to electromagnetic disturbances.PASS
    Risk ManagementA2.1ISO 14971Acceptable level of risk established against risk criteria.Overall the risks are acceptable.
    General Performance - AccuracyA1.5ISO 80601-2-56Storage Test: Greatest calculated error (δ) should not be > 0.09°F (0.05°C) between 95.00°F to 100.40°F (35.00°C to 38.00°C), and not > 0.18°F (0.10°C) between 68.00°F to 94.98°F (20.00°C to 34.99°C) and 100.42°F to 113.00°F (38.01°C to 45.00°C).When error δ
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