510(k) · Cleared
ClearedGIM-STIM OTC TENS/EMS System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Gemore Technology Co, Ltd. · NUH Stimulator, Nerve, Transcutaneous, Over-The-Counter
Cleared on Aug 16, 2019 after a 123-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Aug 16, 2019
- Review
- 123 days
- Class
- Class II
- Product code
- NUH
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in NUH? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new NUH device
- #1 K190783 Health Expert Electronic Stimulator (model…score 15.8 · 7 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
How does its category compare?
All NUH devicesNUH Stimulator, Nerve, Transcutaneous, Over-The-Counter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · NUH
15in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NUH
119in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NUH
No recall names NUH since 2007.
Adverse event reports per year · NUH
7in 2025
MAUDE reports naming product code NUH, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 4 | 161 | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 3 | 148 | 0 | 0 |
| 2011 | 6 | 231 | 0 | 0 |
| 2012 | 6 | 170 | 0 | 0 |
| 2013 | 10 | 189 | 0 | 1 |
| 2014 | 16 | 212 | 0 | 9 |
| 2015 | 14 | 198 | 0 | 11 |
| 2016 | 13 | 145 | 0 | 13 |
| 2017 | 17 | 155 | 0 | 21 |
| 2018 | 16 | 121 | 0 | 18 |
| 2019 | 19 | 213 | 0 | 5 |
| 2020 | 14 | 147 | 0 | 8 |
| 2021 | 14 | 198 | 0 | 7 |
| 2022 | 20 | 103 | 0 | 2 |
| 2023 | 15 | 127 | 0 | 4 |
| 2024 | 20 | 90 | 0 | 7 |
| 2025 | 15 | 119 | 0 | 7 |
| 2026 | 5 | 137 | 0 | — |
What is it indicated for?
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…
Read the full statement (614 words)
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. (Choose EMS Modes P11 to P16)
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K190988 · printed Nov 6, 2026
Cite this page
510(k) Report. “K190988: GIM-STIM OTC TENS/EMS System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K190988
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026