510(k) · Cleared
ClearedGemore Muscle Conditioner;
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 Aug 25, 2011 as substantially equivalent to K091833 (Gemore Technology Co, Ltd., 2009) and 1 other predicate after a 325-day review. Its family tree reaches back 3 generations to 1994.
- Decided
- Aug 25, 2011
- Review
- 325 days
- Class
- Class II
- Product code
- NGX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K940301 (1994). 5 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K940301 | Compex 2 | Biodex Medical Systems, Inc. | 1994 | — |
| −2 | K011880 | Compex Sport | Compex S.A. | 2002 | — |
| −1 | K071666 | Slendertone Enervive, Model 561 | Bio-Medical Research Corp. | 2008 | — |
| 0 (this device) | K102926 | Gemore Muscle Conditioner; | Gemore Technology Co, Ltd. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2009 | 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? (2)
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 |
|---|---|---|---|
| * | K091833 | Gem-Stone Abdominal Training System; Model Gem-Tone 310PE/320PE/330PE/340PE/350PE.Summary 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: - K091 833: GEM-TONE Abdominal Training System, model GEM-TONE 3IOPEI 320PE/330PE/ 34OPEI3SOPE. - K071666: Slendertone Ene… | 2009 |
| * | K071666 | Slendertone Enervive, Model 561Summary page 1…odels to the following FDA cleared OTC devices: - K091 833: GEM-TONE Abdominal Training System, model GEM-TONE 3IOPEI 320PE/330PE/ 34OPEI3SOPE. - K071666: Slendertone EnerVive~m Type 561. 4. Device Description: The Gemore Muscle Conditioner, model GM31 OPE/GM320PE/GM33OPE/GM34… | 2008 |
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.
What does this lineage say?
- The line of descent spans 17 years and passes through 4 companies; a new generation was cleared every 5.9 years on median.
- None of the 5 ancestors has a recall.
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. 2011, 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 Muscle Conditioner, model GM31 CPE/GM32OPE/GM33CPE/GM34OPE/GM35OPE are intended to stimulate healthy muscles in order to improve or facilitate muscle performance. The Gemore Muscle Conditioner, model GM31 OPE/GM32OPE/GM33OPE/GM34OPE/GM35OPE are not intended to be used in conjuction with therapy or treatment of medical diseases or medical conditions of any kind. None of the Gemore Muscle Conditioned training programs are designed for injured or…
Read the full statement (186 words)
The Gemore Muscle Conditioner, model GM31 CPE/GM32OPE/GM33CPE/GM34OPE/GM35OPE are intended to stimulate healthy muscles in order to improve or facilitate muscle performance.
The Gemore Muscle Conditioner, model GM31 OPE/GM32OPE/GM33OPE/GM34OPE/GM35OPE are not intended to be used in conjuction with therapy or treatment of medical diseases or medical conditions of any kind. None of the Gemore Muscle Conditioned training programs are designed for injured or ailing muscle and it's use on such muscle in contraindlicated.
The Gemore Muscle Conditioner, model GM31 OPE/GM32OPE/GM33OPE/GM34OPE/GM35OPE electrically impulse triggering actions potentials on motoneurones of motor nerves(excitations). The excitatiohs of motoneurones are transmitted to the muscle fibers via the motor endplate where they generate mechanical muscle fiber response that correspond to muscle work. Depending on the parameters of the electrical impulses(pulse frequency, duration of contraction, duration of rest, total session duration), different type of muscle work can be imposed on the stimulated muscles.
The various types of muscle work that Gemore Muscle Conditioner can impose on the stimulated muscles are able to improve or facilitate muscle performance. The Gemore Muscle Conditioner, model GM31 OPEIGM32OPEIGM33OPEIGM34OPEI GM35OPE may therefore be considered a technique of muscle training.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K102926 · printed Nov 6, 2026
Cite this page
510(k) Report. “K102926: Gemore Muscle Conditioner;.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102926
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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