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The Gemore OTC TENS, Model GM310PP/GM321PP/GM330PP, is intended for temporary relief of pain associated with sore and aching muscles in the low back as well as upper and lower extremities (arm and/or leg) due to strain from exercise or normal household and work activities

The Gemore OTC TENS. model GM310PP/GM321PP/GM321PP/GM330PP is a dual channel transcutaneous electrical nerve stimulator used for pain relief by applying an electrical current to electrodes, which are attached on the user's skin. The output and waveform characteristic is fixed for every operation mode, only the intensity is adjustable within specified limit. The Gemore OTC TENS, model GM310PP/GM320PP/GM321PP/GM330PP, consist mainly of two parts: the stimulus generator, electrode. The stimulus generates the output current specified as the innut of controller. The output port transmits the output current to the electrode, which is attached to the user's skin so as to transmit this stimulus current for pain relief. The stimulation modes for Gemore OTC TENS is pre-program modes width, pulse rate, frequency. The timer and amplitude for each program are adjustable. This operation way is considered the simplification from the pre-program modes of comparison clear model, OTC TENS For Low Back Pain Relief/ Model GM310PP/GM320PP /GM321PP/ GM330PP (K060222). Every operation mode of Gemore OTC TENS, model GM310PP/GM320PP/ GM321PP/GM330PP has its individual stimulation operation cycle.

The device is an interferential stimulator with TENS indications used for symptomatic relief and management of chronic intractable pain.

The Gemore IF series True sine interferential stimulator / Model: GM3A00IF/GM3A10IF/ GM3A20IF/GM3A50IF are the device which generates the small true-sine pulses of electrical current. The generated current may be delivered to the patient skin and/or underlying nerves through the cable and electrode placed on skin.

<1> For Transcutaneous electrical nerve stimulator. This device is a prescription device and only for symptomatic relief of chronic intractable pain. <2> For Power Muscle Stimulator. - Relaxation of muscle spasms. - Prevention or retardation of disuse atrophy. - Increasing local blood circulation. - Muscle re-education. - Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis. - Maintaining or increasing range of motion. <3> For Interferential Stimulator. The device is an interferential stimulator with TENS indications used for symptomatic relief and management of chronic intractable pain.

The GEM-STIM Combo Stimulator; Model: GM304/GM384/GM394 is the combination of transcutaneous electrical nerve stimulator(TENS) and Interferential stimulation (IF) used for pain relief and/or powered muscle stimulator(EMS) by applying an electrical current to electrodes, which are attached on the patient's skin. The output and waveform is adjustable according to the situation of patient. The GEM-STIM Combo Stimulator: Model: GM304/GM384/GM394 consist mainly of two parts: the stimulus generator, electrode. The stimulus generates the output current specified as the input of controller. The output port transmits the output current to the electrode, which is attached to the patient's skin so as to transmit this stimulus current to the patient for pain relief or muscle stimulation of intended use purpose. The GEM-STIM Combo Stimulator; Model: GM304/GM504 is basically the dual output channels unit which includes several different operation modes as mentioned on the comparison table. These operation modes are generated from the software control by using the microprocessor as its main control unit. And the model GM384/GM394 is the 4 channels model with the housing to install two independent units of GM504 and to provide the similar operation buttons which allow each unit of device being operated independently as that of the model GM504. Basically the new models GM304/GM504/GM384/GM394 was developed from the predicate model GM38Y/Z (K042559). For the new models GM304/GM504/GM384/GM394, the stimulation waveform, significant specification, and the indication for use(IFU) were remained the same as that of Gemore 510(K) cleared predicate model GM38Y/Z (K042559).

The GEMORE TENS System, model GM310TP/GM320TP/GM330TP/GM340TP Transcutaneous Electrical Nerve Stimulators are indicated for: - symptomatic relief of chronic, intractable pain . - adjunctive treatment for post-surgical and post-traumatic acute pain - relief of pain associated with osteoarthritis of the knee and rheumatoid arthritis of the hand

The Gemore TENS System / Model GM310TP, GM320TP, GM330TP, and GM340TP transcutaneous electrical nerve stimulators for pain relief, are the electrically power devices used to apply an electrical current to electrode on a patient's skin to relieve pain. This series of TENS devices are indicated for: - symptomatic relief of chronic, intractable pain - . adjunctive treatment for post-surgical and post-traumatic acute pain . relief of pain associated with osteoarthritis of the knee and rheumatoid arthritis of the hand For this definition of intended use, the Gemore TENS system is classified with the "NYN" & "GZJ" product code under 21CFR/Part 882.5890 FDA regulation classification number. The Gemore TENS system consists mainly of two parts: the stimulus generator and electrode. The stimulus generator generates the output current specified as the input of controller. The output of controller is able to be adjusted for B/C/M/P1/P2/P3/P4/P5 eight operation modes which bear different combination for the output parameters of pulse width, pulse rate, and pulse cycle. For every operation mode, the operator could adjust output intensity, pulse rate and operation time. The output parts transmit the output current to the electrodes which is attached to the patient's skin so as to .transmit the generated stimulus to patient for pain relief treatment. GM310TP/GM320TP/GM330TP/GM340TP is completely identical to that of model as mentioned in our previous submission of GEM STIM TENS, model GM310TE/ GM320TE/GM330TE/GM340TE (K032720). To change the indication for use as that of the chosen predicate devices, Gemore changed the software for these four models. For the device included in this submission, we use the following of our 510(K) legally marketed predicate garment electrodes: - <1>K062675, "Gemore Reuseable Self Adhesive Electrode" ; Wire Series/ Model FA5050 ( 5x5 CM or bigger size) self adhesive electrode. GM310TP/GM320TP/GM330TP/GM340TP is a selectable dual channel, 9V battery operated TENS device with the following features: - <1> The operation function is dual channels completely identical to the model being modified, GM310TE/GM320TE/GM330TE/GM340TE (K032720). - <2> The output of controller is able to be adjusted for B/C/M/P 1/P2/P3/P4/P5 eight operation modes which bear different combination for the output parameters of pulse width, pulse rate, and pulse cvcle. - <3> The output strength is adjustable at 0~80 mA, with maximum setting time 60 minutes counting from switching ON. - <4> The LCD display is provided for the indication of operation status including CH1/CH2, output program mode, pulse width, pulse rate, timer, and battery low warning

The Gemore Muscle Conditioner, model GM310PE/GM320PE/GM330PE/GM340PE/ GM350PE are intended to stimulate healthy muscles in order to improve or facilitate muscle performance. The Gemore Muscle Conditioner, model GM310PE/GM320PE/GM330PE/GM340PE/ GM350PE 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 contraindicated. The Gemore Muscle Conditioner, model GM310PE/GM320PE/GM330PE/GM340PE/ GM350PE electrically impulse triggering actions potentials on motoneurones of motor nerves(excitations). The excitations 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 GM310PE/GM320PE/GM330PE/GM340PE/ GM350PE may therefore be considered a technique of muscle training.

The Gemore Muscle Conditioner, model GM310PE/GM330PE/GM340PE/GM340PE/GM350PE are the battery-operated programmable muscle stimulator intended to improve or facilitate muscle performance by applying an electrical current to electrodes, which is attached on the healthy muscle. Gemore Muscle Conditioner, model GM310PE/GM330PE/GM330PE/GM40PE/GM350PE, consists mainly of three parts: the stimulator , special butterfly type self-adhesive electrode (GelPads), and leader wire fitting for the stimulation of any healthy muscle of body. The stimulator generates the output current specified as the input of controller. The output port transmits the output current to the electrode, which is attached to the specified region, so as to transmit this stimulus current to the healthy muscle the following intended purposes: - to stimulate healthy muscles in order to improve or facilitate muscle performance.

The GEMORE GEM-TONE Abdominal Training System/model GEM-TONE 310PE/320PE/340PE/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.

The GEM-TONE Abdominal Training System model GEM-TONE 310PE/ 320PE /330PE /340PE / 350PE is battery-operated programmable muscle stimulator intended to improve or facilitate muscle performance by applying an electrical current to electrodes, which is attached on abdomen region. GEM-TONE Abdominal Training System model GEM-TONE 310PE / 320PE /330PE /340PE /350PE, consists mainly of three parts: the stimulator , electrodes, and support belts fitting for special parts of body. The stimulator generates the output current specified as the input of controller. The output port transmits the output current to the electrode, which is attached to the specified region, so as to transmit this stimulus current to the region of abdomen for the following intended purposes: - 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. To adequately locate the stimulation on the intended treatment area, the following support belt is provided together with the stimulator: - · The abdomen belt, which is capable of connecting to the both two output channels of stimulator. The stimulation mode for GEM-TONE Abdominal Training System includes several different operation modes as mentioned on the comparison table. These operation modes are generated from the software control by using the microprocessor as its main control unit.

The Gemore Reuseable Self Adhesive Electrode / Wire series, Snap series, and Double side series are intended for use as a disposable, conductive adhesive interface between the patient's skin and the Electrical Stimulator. Gemore Reuseahle Self Adhesive Electrode / Wire series, snap series, and double side series are designed and intended to be used with marketed Electrical Stimulators, i.e. TENS (Transcutaneous Electrical Nerve Stimulation), MENS (Microcurrent Electrical Nerve Stimulation), EMS (Electrical Muscular Stimulation), IF (Interferential) and PGS (Pulsed Galvanic Stimulation).

Gemore Reuseable Self Adhesive Electrode / Wire series and Double side series and Double side series are non-sterile, disposable laminated, flexible structures composed of materials commonly used in this application: First Layer – White spun faced nonwoven tape or White 1/32" thick Polyethylene foam or a polypropylenc substrate, coated with biocompatible adhesive. Second Layer - Conductive plastic film. Third Layer – Biocompatible conductive hydrogel coupling media The electrodes are designed for single-patient/multiple application use. Because of the adhesive nature of the biocompatible hydrogel, no securing materials are required to secure the device to the patient's skin. The electrode has one type of connection point that can be used to connect the stimulation device to the electrodes. This connection point is compatible with all standard, marketed Neurostimulation devices. For the electrical connection, Gemore provides three different types: Snap Series – Snap connection – 1.65" standard size of mail. Snap is provided to connect to the wire female snap. Wire Series – Lead wire assembly – 4.5" ~ 6" wire with .080 in. diameter female socket connected to one side of the wire. Double side series – adhesive gel was also provided at the reverse side of skin contact. With this adhesive side, the electrode can be mounted on the electricity conductive sufface of device without additional lead wire or snap.

The model GM310PP, GM320PP, GM321PP, and GM321PP are intended for temporary relief of pain associated with sore and aching muscles in the lower back due to strain from exercise or normal household and work activities.

The Gemore Low Back Pain Relief System, models GM310PP, GM320PP, GM321PP, and GM330PP are non-invasive devices which are intended for over the counter use in temporary relief of pain associated with sore and aching muscles in the lower back due to stain from exercise or normal household and work activities. The devices contain the following main parts: TENS stimulation unit, Support Belt, Self-adhesive pads, and Snap Cable. The device can be worn on the low back part of user so as to place the stimulation pads on the treatment location of low back. The main stimulation function is achieved through the stimulation unit of GM310PP, GM320PP, GM321PP, and GM330PP. Those stimulation units have been cleared for 510(k) before being submitted on this new submission for OTC application. The K-number for these four models are K032720.

<1> If any one of "OT", "OPP", and/or "OTE" is mounted for Y or Z. This device is a prescription device and only for symptomatic relief of chronic intractable pain. <2> If any one of "OE", and/or "OTE" is mounted for Y or Z. - Relaxation of muscle spasms. - Prevention or retardation of disuse atrophy. - Increasing local blood circulation. - Muscle re-education. - Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis. - Maintaining or increasing range of motion. <3> If any one of "OPE" is mounted for Y or Z. - Relaxation of muscle spasms. <4> If any "2IF" is mounted for Y or Z The device is an interferential stimulator with TENS indications used for symptomatic relief and management of chronic intractable pain. <5> If any "3HV" is mounted for Y or Z The device is an high voltage TENS device with TENS indications used for symptomatic relief and management of chronic intractable pain.

The GEM-TWIN TENS series, including GM38Y/Z and GM39Y/Z(where Y and Z are any combination of OT/OE/OTE/OPE/OPP/2IF/3HV), are transcutaneous electrical nerve stimulator used for pain relief and/or powered muscle stimulator by applying an electrical current to electrodes, which are attached on the patient's skin. The output and waveform is adjustable according to the situation of patient. The GEM-TWIN TENS series, including GM38Y/Z and GM39Y/Z(where Y and Z are any combination of OT/OE/OTE/OPE/OPP/2IF/3HV), consist mainly of three parts: the TWIN housing, stimulation generators, and electrode. The TWIN housing to mount any two stimulation units, and to provide the connection of supply power and stimulation lead wires. The stimulation generator generates the output current specified as the input of controller. The output electrodes transmits the output current to the electrode, which is attached to the patient's skin so as to transmit this stimulus current to the patient for pain relief. The stimulation mode for GEM-TWIN TENS includes several different operation modes as mentioned on the comparison table. These operation modes are generated from the software control by using the microprocessor as its main control unit.