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510(k) Data Aggregation

    K Number
    K190988
    Device Name
    GIM-STIM OTC TENS/EMS System
    Date Cleared
    2019-08-16

    (123 days)

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

    Gemore Technology Co Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    GM511TE & GM511T- for temporary relief of pain associated with sore and aching muscles in the lower back as well as upper and lower extremities (arm and/or leg) due to strain from exercise or normal household and work activities. (Choose TENS Modes P1 to P9 or P17 to P19 and C/B/M/H1/H2 adjustable mode) GM511TE & GM511T- for the symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis (including osteoarthritis and rheumatoid arthritis). It is also used as an adjunctive treatment for post-surgical and post-traumatic acute pain. (Choose TENS Mode P10) GM511TE & GM511E - for use by healthy adults for the stimulation of healthy muscles in order to improve or facilitate muscle performance. (Choose EMS Modes P11 to P16 and C/S/A adjustable mode) GM510TE & GM510T- for temporary relief of pain associated with sore and aching muscles in the lower back as well as upper and lower extremities (arm and/or leg) due to strain from exercise or normal household and work activities. (Choose TENS Modes P1 to P9 or P17 to P19) GM510TE & GM510T- for the symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis (including osteoarthritis and rheumatoid arthritis). It is also used as an adjunctive treatment for post-surgical and post-traumatic acute pain. (Choose TENS Mode P10) GM510TE & GM510E - for use by healthy adults for the stimulation of healthy muscles in order to improve or facilitate muscle performance. (Choose EMS Modes P11 to P16) GM520TE & GM520T- for temporary relief of pain associated with sore and aching muscles in the lower back as well as upper and lower extremities (arm and/or leg) due to strain from exercise or normal household and work activities. (Choose TENS Modes P1 to P9 or P17 to P19) GM520TE & GM520T- for the symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis (including osteoarthritis and rheumatoid arthritis). It is also used as an adjunctive treatment for post-surgical and post-traumatic acute pain. (Choose TENS Mode P10 ) GM520TE & GM520E - for use by healthy adults for the stimulation of healthy muscles in order to improve or facilitate muscle performance. (Choose EMS Modes P11 to P16) GM530TE & GM530T- for temporary relief of pain associated with sore and aching muscles in the lower back as well as upper and lower extremities (arm and/or leg) due to strain from exercise or normal household and work activities. (Choose TENS Modes P1 to P9 or P17 to P19) GM530TE & GM530T- for the symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis (including osteoarthritis and rheumatoid arthritis). It is also used as an adjunctive treatment for post-surgical and post-traumatic acute pain. (Choose TENS Mode P10) GM530TE & GM530E - for use by healthy adults for the stimulation of healthy muscles in order to improve or facilitate muscle performance. (Choose EMS Modes P11 to P16) GM540TE & GM540T- for temporary relief of pain associated with sore and aching muscles in the lower back as well as upper and lower extremities (arm and/or leg) due to strain from exercise or normal household and work activities. (Choose TENS Modes P1 to P9 or P17 to P19) GM540TE & GM540T- for the symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis (including osteoarthritis and rheumatoid arthritis). It is also used as an adjunctive treatment for post-surgical and post-traumatic acute pain. (Choose TENS Mode P10) GM540TE & GM540E - for use by healthy adults for the stimulation of healthy muscles in order to improve or facilitate muscle performance. (ChooseEMS Modes P11 to P16)
    Device Description
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