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PlusCare Temperature Probes are intended to be used for monitoring temperature. The temperature probes are reusable and designed for use with monitors of Philips, Marquette, Mindray, Spacelabs, Siemens, Artema/S&W and other monitors compatible with YSI 400 series temperature probes. These devices are indicated for use by qualified medical personnel only.

The Skin Temperature Probe and Rectum Temperature Probe are used during patient temperature measurement. These probes consist of a connector on the monitor end and a thermistor on the patient end. These probes are to be used with compatible temperature measurement systems only. Temperature probes measure temperature through a resistor that is sensitive to temperature changes. The probe is connected to the monitor either directly by using the connector or by an extension cable. These probes have a skin or core contact with a patient.

The Patient Monitoring Cables are intended to be used with ECG, EKG, Spo2 and BP monitoring devices. The Patient Monitoring Cables are used to connect electrodes, catheters, and/or sensors placed at appropriate sites on the patient to a monitoring device for general monitoring and/or diagnostic evaluation by heath care professional.

Patient Monitoring Cables are the replacements for similar cables manufactured by Original Equipment Manufacturers (OEM) for their respective monitors. It is a non-patient-contact, insulated, shielded, electrical cord with a connector (plug) at both ends designed to transmit electrical power and/or signal (data) between medical devices (e.g., to connect ECG electrodes, SpO2 sensor, IBP transducer to a patient monitor). It is not intended to connect to the mains (i.e., not a mains power cable), does not generate any type of power and/or signal, and has no additional non-electrical conducting or processing functionality.

The Blood Pressure Cuff is an accessory used in conjunction with non-invasive blood pressure measurement systems. The cuff is non-sterile. It is available in neonatal, pediatric and adult sizes. The cuff is not designed, sold, or intended for use except as indicated.

The device comprises tubing attached to an inelastic sleeve with an integrated inflatable bladder that is wrapped around the patient's limb and secured by hook and loop closure. The device tubing is connected to a non-invasive blood pressure measurement system. The subject device is categorized into two types of models according to its reusability.

SpO2 Sensors are indicated for continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) for adult patients weighing greater than 40 kg, pediatric patients weighing 10-50 kg, and neonatal patients weighing no less than 3 kg.

As an accessory of the legally marketed oximeters or patient monitors in the United States, the proposed device SpO2 Sensor is intended for hospital use and continuous monitoring of functional arterial oxygen saturation and pulse rate. The SpO2 sensor consist of a probe attached to the patient's finger. The sensor shall be connected to its corresponding pulse oximeter monitor with a data acquisition system which is used to calculate and display oxygen saturation levels and heart rate conditions. Oxygenation of blood is measured by detecting the infrared and red light absorption characteristics of deoxygenated hemoglobin and oxygenated hemoglobin. Four types of sensor housings are described in this submission: - Reusable soft tip sensor comprised of an integrated silicone rubber tip. - Reusable finger clip sensor with rigid halves and silicone pads - Disposable non- adhesive sensor with sponge and velcro backing. - Disposable adhesive sensors constructed of a medical tape laminate. Each SpO2 sensor has unique labeling and specifications designed for compatibility with the specific oximeters/monitors that have been legally marketed in the United States. The compatible oximeters/monitors are listed in the labeling of each SpO2 sensor.

The Massage Compression Boots are intended for the temporary relief of minor muscle aches and for the temporary increase in circulation to the treated areas. The device can simulate kneading and stroking of tissues by using an inflatable garment.

The subject device is a portable and rechargeable device. It is intended to be an over-the-counter portable inflatable tube massage system which simulates kneading and stroking of tissue by use of an inflatable garment. It can be used to temporarily increase blood circulation and temporarily relieve minor muscle aches and pains. The device, supplied clean and non-sterile, utilizes the pneumatically controlled chambers actuated by an electronically controlled air pump unit. All pump, battery and control components are protectively housed in a plastic case of the control unit that is permanently attached to an inflatable sleeve of multiple air chambers. An ON/OFF button, a SET button, and a display of LEDs provide for user interface. There is also a port for connecting the battery charger/AC adapter plug. The sleeve component consists of multiple air chambers/bladders encased inside a soft medical fabric or equivalent medical for increased patient comfort and biocompatibility compliance.

The Disposable Medical Face Masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These face masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device(s), provided non-sterile.

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To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, arm, and leg, due to strain from exercise or normal household and work activities.

The subject device is a hand-held and battery-powered unit of TENS. It combines the electrical characteristics of TENS with the point stimulation delivered through the electrodes of a metal contact tip and a metal grounding contact on the device has only one TENS mode of the low frequency (2 Hz), and only one button (Power Button). When the Power Button is held down, the device will turn on and deliver the fixed stimulation output to the user's body skin; when the Power Button is released, the device will turn off and the stimulation output will stop. Therefore, the device is very simple and easy to use. The device is designed to generate small pulses of electrical current and delivers the pulses to the user's skin through the metal contact tip such that the underlying nerves and/or muscles are activated for pain relief.

Over-The-Counter Use: TENS: PL-029K.5BL, PL-029K.15, and PL-029T are used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, arm, and leg, due to strain from exercise or normal household and work activities. PL-029K.5BL, PL-029K15, and PL-029T are also intended for symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis. The device of PL-029K5BL and PL-029K15 may be used during sleep. The device of PL-029K15 is labeled for use only with its own compatible electrodes. PMS: PL-029K5BL, PL-029K15, and PL-029T are used to stimulate healthy muscles in order to improve and facilitate muscle performance. To be used for the improvement of muscle tone and firmness, and for strengthening muscles in the arms, abdomen, legs, and buttocks. Not intended for use in any therapy or for the treatment of any medical conditions or diseases. PL-029K5BL, PL-029K15, and PL-029T are also intended to temporarily increase local blood circulation in the healthy muscles of lower extremities. Heating: The device of PL-029T is intended for temporary relief of minor aches and pains. Prescription Use: TENS: PL-029K5BL, PL-029K15, and PL-029T are intended for the following use: - Symptomatic relief and management of chronic, intractable pain - Adjunctive treatment for post-surgical and post-trauma acute pain - Relief of pain associated with arthritis PMS: PL-029K5BL, PL-029K15, and PL-029T are intended for the following use: - Temporary relaxation of muscle spasm - Prevention or retardation of disuse atrophy - Muscle re-education - Maintaining or increasing range of motion - Increase of local blood flow in the treatment area - Prevention of post-surgical venous thrombosis through immediate stimulation of calf muscles

The subject device delivers electric pulses generated to the user's body areas such as the back and foot through the electrodes. The devices include operating elements, such as the ON/OFF button, intensity increase button, and intensity decrease button, and could be attached to electrodes. The device has multiple program modes of different pulse frequencies, covering TENS and PMS that is also called Electrical Muscle Stimulation (EMS). In addition, the device may also provide heat/temperature. While used in the heating mode, the device is coupled with electronically controlled electrodes to provide automatic thermal heat to the skin with the maximum temperature of 43 ℃ for temporary relief of minor aches and pains. The device could be easily operated through its buttons to manually realize its functions, such as turning on/off and increasing/decreasing intensity, providing heat/temperature and displaying/burning calories if needed. The optional wireless control via a remote or Bluetooth APP could provide a secondary operation way to the user, who could be able to wirelessly realize the functions mentioned above. The 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.

Over-The-Counter Use: TENS (Modes 1, 2, 4, 5, 6, 8): PL-029K12 and PL-029K13 are used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, arm, and leg, due to strain from exercise or normal household and work activities. PL-029K12 and PL-029K13 are also intended for symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis. The device of PL-029K12 may be used during sleep. The device of PL-029K12 is labeled for use only with its own compatible electrodes. PMS (also called EMS, Modes 1, 3, 7): PL-029K12 and PL-029K13 are used to stimulate healthy muscles in order to improve and facilitate muscle performance. To be used for the improvement of muscle tone and firmness, and for strengthening muscles in the arms, abdomen, legs, and buttocks. Not intended for use in any therapy or for the treatment of any medical conditions or diseases. PL-029K12 and PL-029K13 are also intended to temporarily increase local blood circulation in the healthy muscles of lower extremities. Heating: The device of PL-029K13 is intended for temporary relief of minor aches and pains. Prescription Use: PL-029K12 and PL-029K13 are intended for the following use: - Symptomatic relief and management of chronic, intractable pain - Adjunctive treatment for post-surgical and post-trauma acute pain - Relief of pain associated with arthritis - Temporary relaxation of muscle spasm - Prevention or retardation of disuse atrophy - Muscle re-education - Maintaining or increasing range of motion - Increase of local blood flow in the treatment area - Prevention of post-surgical venous thrombosis through immediate stimulation of calf muscles

The subject device delivers electric pulses generated to the user's body areas such as the back and foot through the electrodes. The devices include operating of ON/OFF button, intensity increase button, intensity decrease button, and could be attached to electrodes. The device has multiple program modes of different pulse frequencies, covering TENS and PMS that is also called Electrical Muscle Stimulation (EMS). In addition, the device may also provide heat/temperature. While used in the heating mode, the device is coupled with electronically controlled electrodes to provide automatic thermal heat to the skin with the maximum temperature of 43 ℃ for temporary relief of minor aches and pains. The device could be easily operated through its buttons to manually realize its functions, such as turning on/off and increasing/decreasing intensity, providing heat/temperature and displaying/burning calories if needed. The optional wireless control via a remote or Bluetooth APP could provide a secondary operation way to the user, who could be able to wirelessly realize the functions mentioned above. The 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.