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For WL-2315C(M) and WL-2315E(M) models: The WL-2315C(M) and WL-2315E(M) are designed for the symptomatic relief and management of pain. They offer temporary relief from pain associated with dysmenorrhea (menstrual cramps) when used with over-the- counter pain medication. For WL-2405H(M) model: The WL-2405H(M) is designed for symptomatic relief and management of chronic pain and provides temporary relief from sore and aching muscles in the shoulders, waist, back, upper extremities (arms), and lower extremities (legs) due to strain from exercise or daily activities. It also offers temporary relief of pain associated with dysmenorrhea (menstrual cramps) when used with over-the-counter pain medication. Additionally, the WL-2405H(M) features EMS functionality for stimulating healthy muscles to enhance or facilitate muscle performance (select EMS modes). It also provides symptomatic relief and management of chronic, intractable pain and relief from pain associated with arthritis (select TENS mode P8).

The Well-Life Pain relief (Menstrual Plus) Electrical Stimulator is designed for symptomatic relief and management of chronic pain, and for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm) and lower (extremities) leg due to strain from exercise or normal household work activities. It also provides symptomatic relief and management of chronic, intractable pain and relief from pain associated with arthritis This stimulator should be applied to the normal, healthy, dry, and clean skin of adult patients with the aim of stimulating healthy muscles and enhancing muscle performance. There are three available models: WL-2405H(M), WL-2315E(M), and WL-2315C(M). WL-2405H(M) is derived from the WL-2405H (FDA 510K no. K172809) with modifications. It includes the original TENS modes P1-P8 and EMS modes P1-P6, along with two additional TENS modes (P9, P10). TENS P9 is used for Pain Relief/Menstrual pain relief, while TENS P10 is suitable for Pain Relief. The WL-2405H(M) model offers 16 preset modes, with 10 modes for TENS (Transcutaneous Electrical Nerve Stimulation) and 6 modes for EMS (Electrical Muscle Stimulation). It features an LCD/LED display and a user-friendly interface that allows for adjustments to preset modes, output signal intensity, and treatment duration. It also includes two output channels. The WL-2315E(M)/WL-2315C(M) model is a distinct version that exclusively focuses on the TENS P9 mode for dysmenorrhea pain relief, derived from the WL-2405H(M) model. This series of products is an adaptation of the mini-TENS stimulator.

Well-Life Probe Electrode for Stimulation/EMG Probe (Model: SA) include Vaginal Probe SA-2876, SA-25145, SA-20100, SA-3478, SA-2687 & Rectal Probe SA-1483, SA-19108, SA-1563, SA-2486 are intended to provide electromyographic feedback from pelvic musculature or electrical stimulation to pelvic musculature for the purpose of rehabilitation of week pelvic floor muscles and restoration of neuromuscular control during the treatment of urinary incontinence.

Well-Life Probe Electrodes for Stimulation/EMG Probes (Model: SA) contains two types of products, Vaginal Probe and Rectal Probe. The Well-Life Probe Electrode for Stimulation/EMG Probe are intended to provide electromyographic feedback from pelvic musculature or electrical stimulation to pelvic musculature for the purpose of rehabilitation of week pelvic floor muscles and restoration of neuromuscular control during the treatment of urinary incontinence. Well-Life Probe Electrode for Stimulation/EMG (Vaginal Probe) SA-2876, SA-25145, SA-20100, SA-3478, SA-2687 are lightweight cylinders consisting of two or three independent conductive rings or plates that are paired and isolated, physically, and electrically. The cylinder is shaped with a waist and handle for positioning in the vaginal canal for incontinence treatment and easy removal after treatment. It is watertight to allow for washing with soap and water between uses. The electrode is designed for repeated intermittent use by a single user in home or clinic up to 300 times, 15 minutes per session equal to 10 months of daily operation. It does not require sterilization, but does require washing before and after reuse according to the cleaning method as recommended in the user manual. Well-Life Probe Electrode for Stimulation/EMG (Rectal Probe) SA-1483, SA-19108, SA-1563, SA-2486 are lightweight cylinders consisting of two or three independent conductive rings that are paired and isolated, physically, and electrically. The cylinder is shaped with a waist and handle for positioning in the rectal canal for incontinence treatment and easy removal after treatment. It is watertight to allow for washing with soap and water before and after uses. The electrode is designed for repeated intermittent use by a single user in home or clinic up to 300 times, 15 minutes per session equal to 10 months of daily operation. It does not require sterilization, but does require washing before and after reuse according to the cleaning method in user manual. The probe is constructed of stainless steel, acrylonitrile butadiene styrene (ABS), and polyvinyl chloride (PVC).

Intended for temporary relief of pain associated with sore and aching muscles in the upper and lower extremities (arm and/or leg) due to strain from exercise or normal household and work activities.

Well-Life Mini TENS Stimulator (WL-23XXC/WL-23XXE Series) provides a transcutaneous electrical nerve stimulation (TENS) for temporary relief of pain associated with sore and aching muscles due to strain from exercise, normal household chores and work-related activities. The output port transmits the output signal to the electrode, which is attached to the user's skin; with the combination of the Stimulator device parts, the device can be placed on the treatment locations as recommended in the user manual for temporary relief of pain associated with sore and aching muscles in the low back, arthritis as well as upper and lower extremities (arm and/or leg) due to strain from exercise or normal household and work activities. The Well-Life Mini TENS Stimulator (WL-23XXC/WL-23XXE Series) is design changed from OTC MINI PATCH K121353 (Model WL-2301A/WL-2301B). The main differences between the two are disposable battery change to reusable battery, aside from battery changes, the appearance of the devices is also differnt. Also, minor changes include PCBA component placement changes, frame size changes, and new accessories to improve convenience. The definition of model name: WL is abbreviation of Well-Life Healthcare Limited. 23 is symbol of device series which are wireless, no monitor and operated by buttoning only. XX is the symbol for different program and output electrical signal in this device. The last English alphabet is the symbol of the appearance of this device, For C, it is oval shape and for E, it is round shape. The model of Stimulator device are WL-2301C, WL-2301E, WL-2306C and WL-2306E, which include operating elements, such as the ON/OFF button, intensity increase button, and intensity decrease button, and could be attached and detached to electrodes. The Stimulator device offers several different preset programs, and will switch automatically, with 21 minutes per session and will turn off automatically after each session. The Stimulator device could be operated through its buttons to manually realize its functions, such as turning on/off and increasing/decreasing intensity. The accessories of Well-Life Mini TENS Stimulator (WL-23XXC/WL-23XXE Series) are electrode which can be patch or garment. 3 models of patches and 5 models of garments are recommended. There are CM7257, CM169100, CM13070 for electrode patch and Well-Life Garment Electrode -Arm (GM-AM-O-X00), Well-Life Garment Electrode -Elbow (GM-EB-O-X00). Well-Life Garment Electrode -Back Strech Belt (EW-BK-00IE), Well-Life Garment Electrode - Wrist (EW-WR-00IE) and Well-Life Garment-Knee (EW-KN-002E). The electrode Pad composed of non-woven fabric, conductive layer and conductive gel, it is connected to the stimulator through buttons or wires, and is in contact with the skin through conductive gel to transmit electrical signal to the skin to achieve therapeutic effects. The Well-Life Garment Electrode series are blending by Non-conductive textile and conductive textile, from the name of the conductive garment the user can identify the applicable body part, and the textile technology is adjusted to make the product fit on the skin. It is connected to the stimulator through buttons or wires, and is in contact with the skin through conductive textile to transmit electrical signal to the skin to achieve therapeutic effects. The Stimulator device can connect to a specified external IEC 60601-1 compliant power supply for charging of the internal lithium-ion battery. The accessories must comply with AAMI/ ANSI/ES60601- 1, IEC 60601-1-2 and IEC 60601-2-10. The accessories include: An external power adaptor, an electrode cord I cable attached to electrodes pads and battery.

The WL-2405K+ is a digital electrical and heat stimulator for active treatment application as the following: TENS can be used for the following applications: - For temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities (arm) and lower extremities (leg) due to strain from exercise or normal household and work activities. EMS can be used for the following applications: - For healthy adults for the stimulation of healthy muscles in order to improve or facilitate muscle performance. Heat Mode: - Heat can be used for temporary relief of minor aches and pains.

Well-Life OTC TENS/EMS/Heating Stimulator Device, Model no. WL-2405K* provides a combination of transcutaneous electrical nerve stimulation (TENS) for temporary relief of pain associated with sore and aching muscles due to strain from exercise, normal household chores and work related activities, Electrical Muscle Stimulator (EMS) can be used to stimulate healthy muscles in order to facilitate muscle performance, relax muscle spasms, prevent or retard disuse atrophy, reeducate muscles and to maintain or increase the range of motion, Heat can be used in warming the muscle for soothing comfort. The stimulator generates the output current specified as the input of controller. The output port transmits the output current & heat to the electrode, which is attached to the user's skin ; ; with the combination of the main device parts, the device can be placed on the treatment locations as recommended in the user manual for temporary relief of pain associated with sore and aching muscles in the low back, upper and lower extremities (arm and/or leg) due to strain from exercise or normal household and work activities, and to be used to stimulate healthy muscle in order to improve and facilitate muscle performance. The device includes several operating elements, such as the ON/OFF button, intensity increase button, and intensity decrease button, and could be attached and detached to electrodes. The device has multiple program modes of different pulse frequencies, covering TENS/EMS and heat. While used in the heating mode, the device is coupled with electronically controlled electrodes to provide automatic thermal heat to the skin with the maximum temperature of 43°C. For the heating cycle, the temperature will get to 43 degree Celsius in 130 seconds after turning on the heating mode, and when it reaches 43 degree Celsius then it will cool down to body temperature for 20 seconds, then back to 43 degree Celsius for 20 seconds , the cycle will continue for 15 minutes. The device could be operated through its buttons to manually realize its functions, such as turning on/off and increasing/decreasing intensity, providing heat/temperature. Channel 1 can provide electrical stimulation signal, such as TENS/EMS, and it can only be performed by connecting an electrode and wire dedicated to electrical stimulation. Channel 2 can provide heat treatment, and it can only be carried out by connecting heat-exclusive electrode and wires. The exclusive accessories used for electrical stimulation or thermotherapy are marked by color to prevent misuse by the user. If you accidentally use it incorrectly, there will be a protective mechanism in the device to prevent it from operating and causing harm.

The Well Life Garment Electrodes (GM Series) are intended to be used with legally marketed TENS devices. The Well-Life Garment Electrodes (GM Series) will deliver the stimulation signals generated by the stimulator to the body surface with which they are in contact. They can be used on body parts such as arm and elbow.

Well-Life Garment Electrodes (GM, Series), Models AM and EB, are intended to be used with legally Marketed Transcutaneous Electrical Nerve Stimulation (TENS) devices which could be used in place of traditional cutaneous electrode patches. The Well-Life Garment Electrodes (GM Series) are blended with Nonconductive textiles (polyurethane, nylon and polyester) and conductive textiles (Silver Fabric). Non-conductive area is used to fix and support Well-Life Garment Electrodes (GM Series) on the body. Two types of Garment Electrodes are designed. The different series of model means different placement of the garment electrode. For "AM" it is to be place around the arm with conductive areas are on the upper arm and lower arm and there are two sets of snap facing outward, finally for "EB" it is to be place around the elbow with conductive area surrounds the elbow and there are one sets of snap facing outward. There are three sizes for each series of model (S/M/L). The conductive area between different sizes is fixed. There is four conductive area divided into upper arm area and lower arm area on model "AM", the areas is a pair of 39 cm² and a pair of 39 cm². There is only two conductive area on model "EB", the areas is a pair of 25.5 cm2. By adjusting the area of the non-conductive area, the customer's body curve can be fitted. Conductive area is used as a transmission interface which enabling electrical stimulation devices to transmit signals to the skin. The devices must be used wet when in contact with the skin. When using Well-Life Garment Electrodes (GM Series), buckle the one port of lead wire or any connection terminal from legally marketed stimulator to the set of closest snap buttons on Garment Electrodes. Make sure electrical signals could reach the path from electrical stimulation to the Garment Electrodes. For Garment Electrodes with multiple sets of buttons, only one set of buttons can be used at a time. The surface of conductive area has a resistance of less than 14 ohms per inch. The signal is generated by an electrical stimulator, and is transmitted evenly through the wire to the conductive area of the Garment Electrodes, and transmitted to the skin.

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. (Choose TENS Modes P1 through P7) For temporary relief of pain associated with sore and aching muscles in the upper extremities ( arm and/or leg) due to strain from exercise or normal household and work activities. (Choose TENS Modes P1 through P7) For symptomatic relief and management of chromic, intractable pain associated with arthritis. (Choose TENS Mode P8) For use by healthy adults for the stimulation of healthy muscles in order to improve or facilitate muscle performance. (Choose EMS Modes P1 through P6)

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Transcutaneous Electrical Nerve Stimulator (TENS) can be used for the following applications (Available for WR-2603/2603A, and TENS function of WR-2605/ 2605A): · For symptomatic relief of chronic intractable pain Electrical Muscle Stimulation (EMS) on can be used for the following applications (Available for WR-2604/2604A, and EMS function of WR-2605/ 2605A): - · Relax muscle spasms - Prevent or retard disuse atrophy - Increase local blood circulation - · Re-educate muscles - · Maintain or increase the range of motion

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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. (Choose TENS Modes P1 through P7) For temporary relief of pain associated with sore and aching muscles in the upper and lower extremities (arm and/or leg) due to strain from exercise or normal household and work activities.(Choose TENS Modes P1 through P7) For symptomatic relief and management of chronic, intractable pain associated with arthritis. (Choose TENS Modes P8) For use by healthy adults for the stimulation of healthy muscles in order to improve or facilitate muscle performance. (Choose EMS Modes P1 through P6)

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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. (Choose TENS Modes P1 through P7) For temporary relief of pain associated with sore and lower extremities ( arm and/or leg) due to strain from exercise or normal household and work activities.(Choose TENS Modes P1 through P7) For symptomatic relief and management of chronic, intractable pain associated with arthritis. ( Choose TENS Modes P8) For use by healthy adults for the stimulation of healthy muscles in order to improve or facilitate muscle performance. ( Choose EMS Modes P1 through P6)

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The OTC Patch, Model WL-2406, 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 OTC Patch, model WL-2406 is a single 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 outbut and waveform characteristic is fixed for every operation mode, only the intensity is adjustable within specified limit. The OTC Patch, model WL-2406, consist mainly of two parts: the stimulus generator, electrode. The stimulus generator 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 user's skin so as to transmit this stimulus current for pain relief. The stimulation modes for OTC Patch is pre-program modes with fixed pulse rate, frequency, and fixed timer, only amplitude is 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 WL-2406(K052785). Every operation mode of OTC Patch, model WL-2406 has its individual stimulation operation cycle. For the device included in this submission, we use the following of our 510(K) legally marketed predicate electrodes: K082065, "Well-Life Self Adhesive Electrode", CM Series/ model no. CM-130x70, size 130x70mm, snap type. With the combination of the main device parts, the device can be placed on the treatment locations as recommended in the user manual 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.