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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.