Search Results
Found 1 results
510(k) Data Aggregation
K Number
K190988Device Name
GIM-STIM OTC TENS/EMS System
Manufacturer
Date Cleared
2019-08-16
(123 days)
Regulation Number
882.5890Why 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
Not Found
Ask a Question
Ask a specific question about this device
Page 1 of 1