510(k) · Cleared
ClearedGem-Stone Abdominal Training System; Model Gem-Tone 310PE/320PE/330PE/340PE/350PE.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Gemore Technology Co, Ltd. · NGX Stimulator, Muscle, Powered, For Muscle Conditioning
Cleared on Oct 16, 2009 as substantially equivalent to K010335 (Bio-Medical Research, Ltd., 2001) after a 116-day review. Its family tree reaches back 1 generation to 2001. 1 later device descends from it.
- Decided
- Oct 16, 2009
- Review
- 116 days
- Class
- Class II
- Product code
- NGX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K010335 (2001). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK010335 Slendertone Flex, Model, 512Bio-Medical Research, Ltd. · 2001
- This deviceK091833 Gem-Stone Abdominal Training System; Model Gem-Tone…Gemore Technology Co, Ltd. · 2009
- Descendant · cites it directly · 0 of its ownK102926 Gemore Muscle Conditioner;Gemore Technology Co, Ltd. · 2011
Most influential descendants
Showing 1 of 1 · See all- K102926Gemore Muscle Conditioner;Gemore Technology Co, Ltd. · 2011 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K010335 | Slendertone Flex, Model, 512 | Bio-Medical Research, Ltd. | 2001 | — |
| 0 (this device) | K091833 | Gem-Stone Abdominal Training System; Model Gem-Tone… | Gemore Technology Co, Ltd. | 2009 | — |
| +1 | K102926 | Gemore Muscle Conditioner; | Gemore Technology Co, Ltd. | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in NGX? 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 NGX device
- #1 K250146 SofWave Systemscore 15.5 · 12 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K010335 | Slendertone Flex, Model, 512Summary page 1…3. Information of the 510(k) Cleared Device (Predicate Device): For this 510(k) submission, we compared our models to the following FDA cleared OTC devices: -K010335: Slendertone Flex, made by Bio-Medical Research Ltd. 4. Device Description: The GEM-TONE Abdominal Training System model… | 2001 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K102926 | Gemore Muscle Conditioner; | 2011 | 0 |
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.
What does this lineage say?
How does its category compare?
All NGX devicesNGX Stimulator, Muscle, Powered, For Muscle Conditioning: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · NGX
15in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NGX
93in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NGX
2in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NGX
15in 2025
MAUDE reports naming product code NGX, 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 | 7 | 135 | 0 | 0 |
| 2008 | 3 | 209 | 0 | 0 |
| 2009 | 4 | 132 | 0 | 0 |
| 2010 | 6 | 180 | 0 | 0 |
| 2011 | 5 | 291 | 0 | 1 |
| 2012 | 3 | 362 | 0 | 0 |
| 2013 | 6 | 269 | 2 | 1 |
| 2014 | 6 | 298 | 0 | 0 |
| 2015 | 9 | 184 | 0 | 7 |
| 2016 | 4 | 240 | 0 | 21 |
| 2017 | 10 | 108 | 0 | 2 |
| 2018 | 6 | 104 | 0 | 6 |
| 2019 | 14 | 167 | 0 | 4 |
| 2020 | 11 | 207 | 0 | 7 |
| 2021 | 12 | 256 | 0 | 5 |
| 2022 | 6 | 307 | 0 | 7 |
| 2023 | 12 | 96 | 0 | 8 |
| 2024 | 12 | 207 | 0 | 11 |
| 2025 | 15 | 93 | 0 | 15 |
| 2026 | 4 | 118 | 0 | — |
What is it indicated for?
The GEMORE GEM-TONE Abdominal Training System/model GEM-TONE 31OPE/320PE/330PE/340PE/350PE are the electrical muscle stimulator intended for the following indication for use:
Strengthening, toning and firming of the abdomen region.
The GEMORE GEM-TONE Abdominal Training System and its stimulation programs are not designed for injured or ailing muscles, and use on such muscles is contraindication.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K091833 · printed Nov 4, 2026
Cite this page
510(k) Report. “K091833: Gem-Stone Abdominal Training System; Model Gem-Tone 310PE/320PE/330PE/340PE/350PE..” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K091833
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026