# K102926: Gemore Muscle Conditioner;

- Pathway: 510(k) (Traditional)
- Applicant: Gemore Technology Co, Ltd.
- Decided: Aug 25, 2011 after 325 days
- Product code: NGX (Stimulator, Muscle, Powered, For Muscle Conditioning)
- Device class: 2
- Regulation: 21 CFR 890.5850
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K940301 (1994). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091833: Gem-Stone Abdominal Training System; Model Gem-Tone 310PE/320PE/330PE/340PE/350PE., Gemore Technology Co, Ltd. (2009) Summary page 1.
- K071666: Slendertone Enervive, Model 561, Bio-Medical Research Corp. (2008) Summary page 1.

## Indications for use
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.

Source page: https://510kreport.com/device/K102926
Methodology: https://510kreport.com/methodology