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K Number
K163166Device Name
EASYWELL TENS System TENS and Heat, EASYWELL TENS System TENS only
Manufacturer
Date Cleared
2017-08-11
(270 days)
Product Code
Regulation Number
882.5890Why did this record match?
Applicant Name (Manufacturer) :
EASYWELL BIOMEDICALS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The relief of pain associated with sore or aching muscles due to strain from exercise or normal household work activities.
Device Description
The EASYWELL TENS System is a Transcutaneous Electrical Nerve Stimulation (TENS) set consisting of a stimulator console, an electrode patch, gel pads and an AC/DC adaptor. used for pain relief. There are two models available over-the-counter- (1) TENS only, and (2) a combination of TENS and heat for a warming sensation up to 41.0℃ (105.8°F). The TENS session lasts 15 minutes with 3 stages of varying frequencies.
The stimulator console is wearable, weights 32g, with one micro-USB port and one LED light indicator. It has two buttons- "+" button to turn on the stimulator console and to increase the TENS intensity level by 1 (10 intensity levels); "." button to decrease the TENS intensity or turn off the stimulator console when it's pressed for 3 seconds. The green LED light is lit up when the stimulator console is activated. The AC/DC adaptor can be connected to the micro-USB port to recharge the Li-ion battery.
The electrode patch is covered by polyester and nylon blended textile and can be connected to the stimulator console via connectors. Patches with varying shapes and sizes are available to fit different and anatomical positions. Carbon fiber is embedded between the electrode and textile to provide heat conductance and far infrared radiation (model EETTA00 and EETTL00 to provide TENS and heat).
The gel pads are applied to the electrode surface. They are directly in contact with the skin and made from medical grade electrically conductive hydrogel. Thev comply with ISO 10993-5 biological evaluation of medical devices- Part 5: Tests for in vitro cytotoxicity and ISO 10993-10 biological evaluation of medical devices- Part 10: tests for irritation and skin sensitization.
The AC/DC adapter is medical graded which complies with IEC 60601-1 and IEC 60601-1-2
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K Number
K162509Device Name
Infrared Non-contact Thermometer, Model ACT8100
Manufacturer
Date Cleared
2017-03-10
(183 days)
Product Code
Regulation Number
880.2910Why did this record match?
Applicant Name (Manufacturer) :
EASYWELL BIOMEDICALS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Infrared Non-Contact Thermometers, ACT8100, is non-sterile, reusable clinical thermometers intended for the intermittent determination of human body temperature measured at the center of the forehead without contact. The device is intended for use on people of all ages, except pre-term babies or very small (small for gestational age). The device is intended for use in clinical and home use environments.
Device Description
The Infrared Non-Contact Thermometer, ACT8100 is a hand-held device powered by batteries and designed to measure human body temperature without contacting patients. This thermometer can switch modes between forehead and ambient temperatures. The ambient temperature mode is DIRECT MODE and the forehead temperature mode is ADJUSTED MODE. The forehead temperature of the ADJUSTED MODE is calculated by converting the measured temperature of the DIRECT MODE to an oral equivalent temperature without contacting the patient's forehead. Infrared Non-Contact Thermometer, ACT8100 uses a thermopile integrated with a thermistor, a thermistor mounted on the head of the thermometer for ambient temperature readings, and an optoelectronic mechanism that focuses the infrared energy emitted from the user s forehead for the detection of noncontact use and calibration of temperature reading.
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