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510(k) Data Aggregation

    K Number
    K200838
    Device Name
    Tyece OTC TENS Model
    Manufacturer
    Date Cleared
    2020-08-12

    (134 days)

    Product Code
    Regulation Number
    882.5890
    Why did this record match?
    Applicant Name (Manufacturer) :

    Tyece Limited

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Tyece OTC TENS Device EM26 is intended for use by healthy adults for temporary relief of pain associated with sore and aching muscles in the shoulder and neck due to strain from exercise or normal household and work activities. The Tyece OTC TENS Device EM27 is intended for use by healthy adults for temporary relief of pain associated with sore and aching muscles in the lower extremities (leg) due to strain from exercise or normal household and work activities. The Tyece OTC TENS Device EM28 is intended for use by healthy adults for temporary relief of pain associated with sore and aching muscles in the upper extremities (arm) due to strain from exercise or normal household and work activities. The Tyece OTC TENS Device EM29 is intended for use by healthy adults for temporary relief of pain associated with sore and aching muscles in the upper extremities (arm) and lower extremities (leg) due to strain from exercise or normal household and work activities.
    Device Description
    The Tyece OTC TENS Device EM26, EM27, EM28 and EM29 powered by 4.5V (3 x 1.5V AAA /Alkaline batteries), is similar to the predicate device, LT3060 (K130802), with the following features: a. It is a portable single-channel, battery operated Transcutaneous Electrical Nerve Stimulator stimulation system. The predicate is a dual-channel TENS device. b. It contains 4 programs, similar to the predicate device which has 12 programs c. The output strength is adjustable from 0-110mA, similar to the predicate device at 0-96mA, via regulated voltage. d. The LCD display is provided for the indication of operation status including operation mode, output program mode, output intensity, time to cut-off, and battery low indication.
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