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The Heat StimPlus, Model FDES115 is intended TENS: This function is designated to be used 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 work activities. EMS: This function is designed to be used for stimulating healthy muscles in order to improve and facilitate muscle performance.

The Heat StimPlus(Model:FDES115) is a small battery operated OTC device that provides a combination of TENS/EMS and heat for a warming sensation. It delivers TENS/EMS only or alternating combinations of TENS/EMS and heat. TENS/EMS and heat are never applied at the same time. The device can connect to a specified external IEC 60601-1 compliant power supply for charging of the internal lithium ion battery. The device complies with AAMI/ ANSI/ES60601-1, IEC 60601-1-2 and IEC 60601-2-10. FDES 115 feature two independent output channels and four self-adhesive electrode gel pads. They offer a wide range of functions for increasing general well- being, pain relief, maintaining physical fitness, relaxation, muscle revitalization and combating tiredness. For these purpose, the user can either choose from pre-set programs or specify their own to suit the user's individual needs. Stimulation from FDES115 is intended for application to the following areas: lower back, arms, legs, shoulder or foot. Software controls all controls and indicators. Software controls waveform characteristics. The accessories include:Type-C cable,an electrode cord / cable attached to electrodes pads and a Pad holder for storage. The electrode pads allow for stimulation and have resistive elements to provide heat which is powered by the FDES115The electrodes cleared include the electrode patches/pads and electrode garments. which could be packaged together with the 510(k)-cleared devices or packaged separately as the replacement electrodes for 510(k)-cleared devices. The exact percentage of ingredients used in the electrode patch/pad may be withheld as the trade secret. The device is battery powered and can be connected to an external power supply for charging the internal battery. The battery is lithium ion and is not user serviceable or accessible. The only external connections on the device are the power input and the electrode connector there is no connection to any other device. The FDES115 is considered - OTC devices.

FDES106 (ED406) Mini TENS &EMS Device For program N1, B and H of TENS mode To be used for temporary relief of pain associated with sore and aching muscles due to strain from exercise or normal household work activities. For program E1 and E2 of EMS mode Used to stimulate healthy muscles in order to improve and facilitate muscle performance. FDES106A (ED406A) Multi-function Mini TENS &EMS Device For program N1, B and H of TENS mode To be used for temporary relief of pain associated with sore and aching muscles in the lower back, abdomen, thigh, and arm due to strain from exercise or normal household work activities. For program E1 and E2 of EMS mode Used to stimulate healthy muscles in the lower back, abdomen, thigh, and arm in order to improve and facilitate muscle performance. FDES105 (ED405) Pain Relief Plaster To be used for temporary relief of pain associated with sore and aching muscles due to strain from exercise or normal household work activities. FDES107 (ED407) Abdominal Fitness Belt Used to stimulate healthy muscles in order to improve and facilitate muscle performance for abdominal.

The FDES106(ED406) Series Stimulator, which includes models FDES106(ED406), FDES106A(ED406A), FDES105(ED405) and FDES107(ED407), are Transcutaneous Electrical Nerve Stimulator and muscle stimulator for pain relief and/or Electrical Muscle Stimulator. The stimulator sends gentle electrical current to underlying nerves and muscle group via electrodes applied on the skin. The parameters of units are controlled by the press buttons. Its intensity level is adjustable according to the needs of patients. The device unit of FDES106(ED406) and FDES106A(ED406A) are same, only the applied part are different: the applied part of FDES106(ED406) is electrode pad; the applied part of FDES106A(ED406A) is electrode belt. They are portable device, battery powered (3.0V DC) multi-function device offering both Transcutaneous Electrical Nerve Stimulator(TENS) and Powered Muscle Stimulator (EMS) qualities in one device. The FDES106 (ED406) includes FDE$105 (ED405). FDES106 (ED406) has TENS and EMS two treatment mode 5 programs (N, B, H, E1, E2), FDES105 (ED405) only has TENS mode 5 treatment programs (N1, N2, B, H, F).Their appearance, structure, circuit, software operation is exactly the same, only different output treatment procedure. FDES107 (ED407) has 10 EMS treatment process, whose intended use, waveform characteristics and is basically the same as FDES106 (ED406) EMS model, The difference is from only operation mode and structure appearance. Independent channel (by electrode pad or electrode belt) that effectively transfers your desired choice of pre-programmed electrical pulses directly through electrode pad or electrode belt) to suggested area of the body where the electrode are placed, causing minimal muscle contractions. The FDES106 (ED406 ) and FDES106A (ED406A ) have 3 TENS programs and 2 EMS programs; FDES105 (ED405) have 5 TENS programs; FDES107 (ED107) have 10 EMS programs.

FDES101(ED401) TENS and EMS Stimulator For TENS mode 1. Symptomatic relief of chronic intractable pain 2. Post traumatic pain 3. post surgical pain For EMS mode 1. Relaxation of muscle spasm. 2. Increase of local blood flow circulation 3. Prevention or retardation of disuse atrophy 4. Muscle re-education 5. Maintaining or increasing range of motion 6. Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis FDES102(ED402) TENS Stimulator 1. Symptomatic relief of chronic intractable pain 2. Post traumatic pain 3. Post surgical pain FDES103(ED403) EMS Stimulator 1. Relaxation of muscle spasm. 2. Increase of blood flow circulation 3. Prevention or retardation of disuse atrophy 4. Muscle re-education 5. Maintaining or increasing range of motion. 6. Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis

The FDES101(ED401) Series Stimulator, which includes models FDES101(ED401), FDES102(ED402) and FDES103(ED403), are Transcutaneous Electrical Nerve Stimulator and muscle stimulator for pain relief and/or Electrical Muscle Stimulator. The stimulator sends gentle electrical current to underlying nerves and muscle group via electrodes applied on the skin. The parameters of units are controlled by the press buttons. Its intensity level is adjustable according to the needs of patients. The three models FDES101(ED401), FDES102(ED402) and FDES103(ED403) have the same housing in a molded portable plastic case with a viewable LCD display, an accessible keypad, and accessible battery storage compartment. The case shape is rectangular. The LCD is located on the upper half of the rectangular face of the device, above the keypad. The LCD is used to display system information to the user. The device is equipped with a keypad composed of push buttons which are located below the LCD. The function for each button is defined by a symbol on the LCD corresponding to the button immediately below it. The process to set the parameter and attach lead wires to the five models is also the same. Yet, they have different liquid crystal display and parameters for patients to create their own settings. The FDES101(ED401) TENS and EMS Stimulator is the combination unit with the TENS. EMS functions, the function can be selected by press buttons. The range of settings is identical to those of FDES102(ED402) and FDES103(ED403). The difference on the five units can be identified by the LCD display.

Famidoc Infrared Thermometers, models: FDIR-V2, FDIR-V4, FDIR-V5, FDIR-V6, FDIR-V7, FDIR-V9, FDIR-V9-3, FDIR-V10, FDIR-V15, are intended for intermittent measurement and monitoring of human body temperature by consumers in the home.

Famidoc Infrared FDIR series Thermometers are hand-held, reusable, battery operated devices, which can measure human body temperature in two ways. - On forehead, the skin temperature on one's forehead. - In ear, the tympanic temperature in one's ear. The operation principle is based on Infrared Sensor technology. The IR sensor can output different signal when measuring different object temperature or in different ambient temperature, and the ASIC can turn the signal from IR Sensor to a digital value and display it on the LCD. The subject devices (Models: FDIR-V2, FDIR-V4, FDIR-V6, FDIR-V6, FDIR-V7, FDIR-V9, FDIR-V9-3, FDIR-V10, FDIR-V15) are the same series in Famidoc. Their design principle, intended use, indications for use, material, control keys, software and the applicable standards are the same. The differences between them are appearance, some parameters (e.g. LCD size), and some minor functions (e.g. Voice function).

Famidoc Digital Clinical Thermometers are intended for the measurement and monitoring of human body temperature, by doctor or consumers in the hospital or home. It is used alone for human beings at all ages.

Famidoc Digital Clinical Thermometer (model FDTH-V0-1, FDTH-V0-2, FDTH-V0-3, FDTH-V0-4) are hand-held, reusable, battery operated, maximum device that can measures human body temperature. Models FDTH-V0-1, FDTH-V0-2, FDTH-V0-3, FDTH-V0-4 have the same indication for use. the difference points are their shapes、waterproof function and measurement speed. The operation principle is based on thermistor and ASIC technology, a thermistor using as temperature sensor, the sensor's signal is then calculated and displayed by an ASIC. The digital thermometer comprises a thermistor for temperature sensing, a reference resistor for comparing the resistance of the thermistor, a buzzer for sounding effect, an ASIC and a LCD for calculating and displaying the target temperature digitally which the thermistor is immersed.

The device is intended for the intermittent measurement and monitoring of human body temperature, by consumers in the home.

Infrared Thermometer Model: FDIR-VI is a hand-held, reusable, battery operated, maximum device that can measures human body temperature by two ways. 1. on forehead, the skin temperature on one's forehead. 2. in ear, the tympanic temperature in one's ear. The operation principle is based on Infrared Sensor technology. IR Sensor can putout different signal when measuring different object temperature or in different ambient temperature, an ASIC can turn the signal from IR Sensor to a digital value and display it by LCD.