Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Gemore Technology Co, Ltd. — Predicate Candidate Screening
14 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
99 daysmedian FDA review time
325 days90th percentile
14clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K190988 | GIM-STIM OTC TENS/EMS System | Gemore Technology Co, Ltd. | 2019-08-16 | 123 | 0 |
| K150681 | GEMORE OTC TENS | Gemore Technology Co, Ltd. | 2015-05-12 | 56 | 0 |
| K122944 | GEMORE TRUE SINE INTERFERENTIAL STIMULATOR | Gemore Technology Co, Ltd. | 2012-12-21 | 88 | 0 |
| K122948 | GEM-STIM COMBO STIMULATOR | Gemore Technology Co, Ltd. | 2012-12-21 | 88 | 0 |
| K120569 | GEMORE TENS SYSTEM | Gemore Technology Co, Ltd. | 2012-07-20 | 144 | 0 |
| K102933 | GEM-TONE BODY TRAINING SYSTEM | Gemore Technology Co, Ltd. | 2011-09-02 | 333 | 0 |
| K102926 | GEMORE MUSCLE CONDITIONER; | Gemore Technology Co, Ltd. | 2011-08-25 | 325 | 0 |
| K091833 | GEM-STONE ABDOMINAL TRAINING SYSTEM; MODEL GEM-TONE 310PE/32 | Gemore Technology Co, Ltd. | 2009-10-16 | 116 | 0 |
| K062675 | GEMORE REUSEABLE SELF ADHESIVE ELECTRODE, MODELS WIRE SERIES | Gemore Technology Co, Ltd. | 2007-01-04 | 118 | 0 |
| K060222 | LOW BACK PAIN RELIEF SYSTEM /MODELS GM310PP,GM320PP,GM321PP, | Gemore Technology Co, Ltd. | 2006-04-28 | 88 | 0 |
| K042559 | GEM-TWIN TENS/ MODELS GM3XY/Z | Gemore Technology Co, Ltd. | 2004-11-17 | 57 | 0 |
| K032994 | GM3 SERIES HV TENS, MODEL GM3X3HV (WHERE X IS PARAMETER OF D | Gemore Technology Co, Ltd. | 2003-12-16 | 82 | 0 |
| K032719 | GM3 SERIES IF TENS, MODEL GM3X2IF (WHERE X IS A PARAMETER OF | Gemore Technology Co, Ltd. | 2003-12-10 | 99 | 0 |
| K032720 | GEM-STIM TENS, MODELS GM3XY AND GM3AXY | Gemore Technology Co, Ltd. | 2003-12-10 | 99 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda