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The Ultraviolet Phototherapy Device is an Ultraviolet Light Emitting Medical Device. It is intended for use in localized phototherapeutic treatment of dermatologic conditions such as psoriasis, vitiligo, atopic dermatitis (eczema), seborrheic dermatitis and leukoderma on all skin types (I-VI).

Ultraviolet Phototherapy Device

The devices are intended for spot checking or continuous monitoring of functional arterial oxygen saturation and pulse rate in non-invasive oximeter equipment. The sensors are reusable depending on models, and are intended for adult, pediatric or infant, depending on models. They shall be used in healthcare settings.

The proposed device, SpO2 Sensors are accessories to the oximeters, which are intended for spot checking or continuous monitoring of functional arterial oxygen saturation and pulse rate in noninvasive U.S. legally marketed oximeters or patient monitors. The sensors are reusable or disposable depending on models, and are intended for adult, pediatric or infant, depending on models. The proposed devices measure, along with the corresponding oximeters, non-invasively, the arterial oxygen saturation of blood. The measurement method is based on the red and infrared light absorption of hemoglobin and oxyhemoglobin. Each sensor has two LEDs, emitting both red and infrared light, and a photodiode. The light is emitted through human finger and received by a photodiode. Then the received signal is forwarded to the corresponding oximeter that amplifies the signal and an algorithm that calculates the ratio. The saturation value is determined by the percentage ratio of the oxygenated hemoglobin (HbO2) to the total amount of hemoglobin (Hb). The patient contact components include cable and sensor. The contact level is surface device and contact duration is limited contact (less than 24h).

The ECG Disposable Lead Wires are intended to be used with ECG. The lead wire is used to connect electrodes placed at appropriate sites on the patient to ECG for general monitoring and/or diagnostic evaluation by health care professional.

The ECG Disposable Lead Wires are comprised of patient end termination, leadwire and patient leadwire connector. The device is used to transmit ECG signals from electrodes which are affixed to the patient's body for both diagnostic and monitoring purposes. Each lead wire is attached to ECG patient electrodes. The lead wire connector plugs into one end of the external trunk cable which are plug into an ECG monitor.

Blood Pressure Cuffs, include reusable and disposable, are intended to be wrapped on the upper arm and used with a non-invasive blood pressure monitor system to determine blood parameters on neonate, pediatric and adult patients.

The proposed device, Blood Pressure Cuff, is a rectangle soft inelastic sleeve. Some types are disposable without a bladder; some are reusable with a bladder or without a bladder. There is a single-tube or twin-tube connected to the bladder and the NIBP measurement device for inflating and deflating. It is available in various sizes for different arm range. It is provided non-sterile and each cuff. It is used in conjunction with NIBP Monitor System.

The APK SpO2 Pulse Oximeter Sensor (Resuable) is intended for spot checking or continuous monitoring of functional arterial oxygen saturation and pulse rate in non-invasive with oximeter equipment, which are intended for adult or pediatric patients (more than 5kg) in hospital-type facilities, and home environments. The APK SpO2 Pulse Oximeter sensor (Disposable) is intended for single use when continuous noninvasive arterial oxygen saturation and pulse rate monitoring are adults or pediatric patients (more than 5kg) in hospital-type facilities, and home environments.

The applicant sensor APK SpO2 Pulse Oximeter Sensor (Reusable and Disposable) measure, non-invasively, the arterial oxygen saturation of blood. The measurement method is based on the red and infrared light absorption of hemoglobin and oxyhemoglobin. Light of a red and infrared light source is emitted through human tissue and received by a photodiode. The measurement is based on the absorption of light, which is emitted through human tissue (for example through the index finger). The light comes from two sources (red LED and infrared LED) with different wavelengths and is received by a photodiode. Out of the different absorption behavior of the red and infrared light a so-called ratio can be calculated. The saturation value is defined by the percentage ratio of the oxygenated hemoglobin [HbO2] to the total amount of hemoglobin [Hb]. Those sensors contain a red and infrared light source and a photodiode receiving the non-absorbed red and infrared light. The received signals are forwarded to a measurement device that amplifies the acquired signal and an algorithm that calculates the ratio and converts via a validated calibration table the ratio to a saturation value. The device is not software-driven. The applicant sensors are not for implant. Those sensors are not sterile and do not need sterilization or re-sterilization. The device is for prescription. The device does contain drug or biological product.