DARBY DENTAL SUPPLY, LLC 9508856 Darby Dental Supply, LLC

SudoC device is a medical device for the measurement of galvanic skin response related to the function of the sweat glands.

The TBL-ABI is indicated for use on adult subjects at risk of having or developing peripheral arterial disease (PAD). TBL-ABI is intended for the rapid measurement of ankle-brachial pressure index (ABPI), or ankle-brachial index (ABI), and pulse volume recording (PVR) / volume plethysmography in adults. It is suitable for use in wound care assessment, for assessing symptomatic PAD, and as a screening device for PAD. It may also be used on patients with venous or arterial ulcers prior to the application of compression therapy. TBL-ABI can be used on patients with unilateral lower limb amputation.

To spot check or monitor Oxygen saturation of arterial hemoglobin (SpO2%) and pulse rate. To analyze the pulse waveform (Photoelectrical Plethysmography or PP) provided by the oximeter. It only provides mathematical analyses of the input of the SpO2 measurement. To analyze the basic rhythms of the NN or RR intervals in heart rate, both in the time domain and in the frequency domain (short time 5 minutes). It only provides mathematical analysis of the input of the heart rate variability. The mathematical analysis of Photoelectrical Plethysmography and HRV ARE NOT intended use for diagnosis. The software provides a visual alarm for the values of the heart rate and/or SpO2 percent out of the normal range and for the bad quality signal transmission. The data are stored in PC in the Backup system of the LD-Oxi software. The device is intended use only for adult subjects (> 20 years old) This Oximeter is intended to be used in spot-checking (5 minutes). The device is intended use in licensed practitioner’s office This device is no intended to be used at home, in hospital or out-of-hospital transport The device is not intended use in support life and not for continuously monitoring The system will be use by practitioner.