Gemore Technology Co, Ltd.: FDA filings under this applicant name
FDA lists 14 510(k) clearances under the applicant name “Gemore Technology Co, Ltd.” (first 2003, latest 2019), across 5 product codes in 2 review panels. Median 510(k) review time under this name: 99 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 3 | 88 |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 1 | 56 |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 1 | 123 |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Gemore Technology Co, Ltd. took a median 123 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 140 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GZJ | Stimulator, Nerve, Transcutaneous, For Pain Relief | 5 | 5 |
| NGX | Stimulator, Muscle, Powered, For Muscle Conditioning | 3 | 3 |
| NUH | Stimulator, Nerve, Transcutaneous, Over-The-Counter | 3 | 3 |
| LIH | Interferential Current Therapy | 2 | 2 |
| GXY | Electrode, Cutaneous | 1 | 1 |
Review panels
- Neurology (11)
- Physical Medicine (3)
Most recent Gemore Technology Co, Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K190988 | GIM-STIM OTC TENS/EMS System | NUH | 2019-08-16 | 123 |
| K150681 | GEMORE OTC TENS | NUH | 2015-05-12 | 56 |
| K122948 | GEM-STIM COMBO STIMULATOR | GZJ | 2012-12-21 | 88 |
| K122944 | GEMORE TRUE SINE INTERFERENTIAL STIMULATOR | LIH | 2012-12-21 | 88 |
| K120569 | GEMORE TENS SYSTEM | GZJ | 2012-07-20 | 144 |
| K102933 | GEM-TONE BODY TRAINING SYSTEM | NGX | 2011-09-02 | 333 |
| K102926 | GEMORE MUSCLE CONDITIONER; | NGX | 2011-08-25 | 325 |
| K091833 | GEM-STONE ABDOMINAL TRAINING SYSTEM; MODEL GEM-TONE 310PE/320PE/330PE/340PE/350PE. | NGX | 2009-10-16 | 116 |
| K062675 | GEMORE REUSEABLE SELF ADHESIVE ELECTRODE, MODELS WIRE SERIES, SNAP SERIES AND DOUBLE SIDE SERIES | GXY | 2007-01-04 | 118 |
| K060222 | LOW BACK PAIN RELIEF SYSTEM /MODELS GM310PP,GM320PP,GM321PP, AND GM330PP | NUH | 2006-04-28 | 88 |
4 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Gemore Technology Co, Ltd..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Gemore Technology Co, Ltd.?
FDA lists 14 510(k) clearances under the applicant name “Gemore Technology Co, Ltd.” (first 2003, latest 2019), across 5 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Gemore Technology Co, Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Gemore Technology Co, Ltd. is 99 days.
Which FDA product codes appear under Gemore Technology Co, Ltd.?
The most frequent FDA product codes under this applicant name are GZJ (Stimulator, Nerve, Transcutaneous, For Pain Relief, 5); NGX (Stimulator, Muscle, Powered, For Muscle Conditioning, 3); NUH (Stimulator, Nerve, Transcutaneous, Over-The-Counter, 3).
Next steps
- See all 14 Gemore Technology Co, Ltd. clearances with predicates and recalls
- Run predicate analysis for product code GZJ, Gemore Technology Co, Ltd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.