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Over-The-Counter Use: a. Model R-C101C is indicated for OTC TENS and OTC EMS. OTC TENS(NUH) It is used for temporary relief of pain associated with sore and aching muscles in the neck, shoulder, back, upper extremities (arm) and lower extremities (leg) due to strain from exercise or normal household work activities. OTC EMS(NGX) This mode is designed to be used for stimulate healthy muscles in order to improve and facilitate muscle performance. b. Model R-C101D is indicated for OTC TENS. It is used for temporary relief of pain associated with sore and aching muscles in the neck, shoulder, back, upper extremities (arm) and lower extremities (leg) due to strain from exercise or normal household work activities. c. Model R-C101F is indicated for OTC TENS and OTC EMS. OTC TENS(NUH) It is used for temporary relief of pain associated with sore and aching muscles in the neck, shoulder, back, upper extremities (arm) and lower extremities (leg) due to strain from exercise or normal household work activities. OTC EMS(NGX) This mode is designed to be used for stimulate healthy muscles in order to improve and facilitate muscle performance. d. Model R-C101G is indicated for OTC TENS and OTC EMS. OTC TENS(NUH) It is used for temporary relief of pain associated with sore and aching muscles in the neck, shoulder, back, upper extremities (arm) and lower extremities (leg) due to strain from exercise or normal household work activities. OTC EMS(NGX) This mode is designed to be used for stimulate healthy muscles in order to improve and facilitate muscle performance. e. Model F100 is indicated for OTC TENS and OTC EMS. OTC TENS(NUH) It is used for temporary relief of pain associated with sore and aching muscles in the neck, shoulder, back, upper extremities (arm) and lower extremities (leg) due to strain from exercise or normal household work activities. OTC EMS(NGX) This mode is designed to be used for stimulate healthy muscles in order to improve and facilitate muscle performance. f. Model MINI-TENS-COMB is indicated for OTC TENS. OTC TENS(NUH) It is used for temporary relief of pain associated with sore and aching muscles in the neck, shoulder, back, upper extremities (arm) and lower extremities (leg) due to strain from exercise or normal household work activities. g. Model R-C101I is indicated for OTC TENS. OTC TENS(NUH) It is used for temporary relief of pain associated with sore and aching muscles in the neck, shoulder, back, upper extremities (arm) and lower extremities (leg) due to strain from exercise or normal household work activities. h. Model TENS3500 is indicated for OTC TENS. OTC TENS(NUH) It is used for temporary relief of pain associated with sore and aching muscles in the neck, shoulder, back, upper extremities (arm) and lower extremities (leg) due to strain from exercise or normal household work activities. Prescription Use: a. Model R-C101D is indicated for Rx TENS. Rx TENS(GZJ) 1)Symptomatic relief of chronic intractable pain; 2)Post traumatic pain; 3)Post surgical pain; b. Model R-C101G is indicated for Rx TENS and Rx EMS. Rx TENS(GZJ) 1)Symptomatic relief of chronic intractable pain; 2)Post traumatic pain; 3)Post surgical pain; Rx EMS(IPF): 1)Relaxation of muscle spasm; 2)Increase of local blood flow circulation: 3)Prevention or retardation of disuse atrophy: 4)Muscle re-education: 5)Maintaining or increasing range of motion; 6)Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis. c. Model R-C101C, is indicated for Rx TENS and Rx EMS. Rx TENS(GZJ) : 1)Symptomatic rlief of chronic intractable pain; 2)Post traumatic pain; 3)Post surgical pain; Rx EMS(IPF): 1)Relaxation of muscle spasm; 2)Increase of local blood flow circulation: 3)Prevention or retardation of disuse atrophy: 4)Muscle re-education: 5)Maintaining or increasing range of motion; 6)Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis. d. Model F100 is indicated for Rx TENS and Rx EMS. Rx TENS(GZJ) : 1)Symptomatic relief of chronic intractable pain; 2)Post traumatic pain; 3)Post surgical pain; Rx EMS(IPF): 1)Relaxation of muscle spasm; 2)Increase of local blood flow circulation: 3)Prevention or retardation of disuse atrophy: 4)Muscle re-education: 5)Maintaining or increasing range of motion; 6)Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis. e. Model MINI-TENS-COMB is indicated for Rx TENS. 1)Symptomatic relief of chronic intractable pain; 2)Post traumatic pain; 3)Post surgical pain; f. Model R-C101F is indicated for Rx TENS and Rx EMS. Rx TENS(GZJ) : 1)Symptomatic relief of chronic intractable pain; 2)Post traumatic pain; 3)Post surgical pain; Rx EMS(IPF): 1)Relaxation of muscle spasm; 2)Increase of local blood flow circulation: 3)Prevention or retardation of disuse atrophy: 4)Muscle re-education: 5)Maintaining or increasing range of motion; 6)Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis. g. Model R-C101I is indicated for Rx TENS. Rx TENS(GZJ) : 1)Symptomatic relief of chronic intractable pain; 2)Post traumatic pain; 3)Post surgical pain; h. Model TENS3500 is indicated for Rx TENS. Rx TENS(GZJ) : 1)Symptomatic relief of chronic intractable pain; 2)Post traumatic pain; 3)Post surgical pain;

Combo Electrotherapy Device (Model:R-C101C,R-C101F,R-C101G,F100,MINI-TENS-COMB,R-C1011, TENS3500) are Transcutaneous Electrical Nerve Stimulator and muscle stimulator The Device feature two independent output channels and four self-adhesive electrode gel pads. The stimulator sends gentle electrical current to underlying nerves and muscle group via electrode applied on the skin. They offer a wide range of functions for increasing general well- being, pain relief, maintaining physical fitness, relaxation.For these purpose, the user can either choose from pre-set programs or specify their own to suit the user's individual needs. Software controls all controls and indicators. Software controls waveform characteristics. The 8 models have Similar housing with a viewable LCD display,an accessible keypad.The LCD is located on the upper half of the rectangular face of the device, above the keypad. The LCD is used to display system information to the user. The device is battery powered and can be connected to an external power supply for charging the internal battery. The battery is 3.7V D.C.,Li-ion batteries 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 Battery Charger is not provided in the package, but users will choose adapters that meet the IEC 60601-1 medical standard.

The CIRCA Temperature Monitoring System is composed of CIRCA Temperature Monitor and CIRCA MATRIX12 M Probe and is intended for the continuous detection, measurement and visualization (in ℃) of esophageal temperature. The intended environments of use are operating rooms and interventional electrophysiology rooms. The CIRCA Monitor must be used in conjunction with the CIRCA MATRIX12 M Probe. The role of esophageal temperature monitoring using this device in reducing the risk of cardiac ablation-related esophageal injury has not been established. The performance of the CIRCA Temperature Monitoring System in detecting esophageal temperature changes as a result of energy delivery during cardiac ablation procedures has not been evaluated.

The CIRCA Scientific Temperature Monitoring System consists of a touch-screen monitor, interconnect cables, and an esophageal temperature probe. The monitor displays 12 temperature probe sensor readings (°C), the minimum and maximum temperature of all sensors, and contains an alarm system with userselected levels. The measured temperatures can be stored in the internal memory of the device and examined at a later time on an external personal computer (after exporting the corresponding data file to an USB flash drive). The MATRIX12 M Esophageal Temperature Probe provides continuous temperature measurement (°C) and operates in direct mode (operating mode of a clinical thermometer where the output temperature is an unadiusted temperature that represents the temperature of the measuring site to which the probe is coupled). The probe contains 12 thermistor sensors located in a 3 x 4 sensor array. The sensors measure temperature by a thermistor that is sensitive to temperature changes. The probe is connected to the CIRCA Scientific monitor by using an interconnect cable. The 14Fr diameter probe is placed inside the esophagus. The Probe is also equipped with 4 electrode sensors. By connecting the MATRIX12 M Probe to a 3D cardiac mapping system through the optional component Mapping Interconnect Cable, the probe can be visualized inside a 3D model of the patient's body for placement.

The CIRCA Temperature Monitoring System is composed of CIRCA Temperature Monitor and CIRCA S-CATH M Probe and is intended for the continuous detection, measurement and visualization (in °C) of esophageal temperature. The intended environments of use are operating rooms and interventional electrophysiology rooms. The CIRCA Monitor must be used in conjunction with the CIRCA S-CATH M Probe. The role of esophageal temperature monitoring using this device in reducing the risk of cardiac ablation-related esophageal injury has not been established. The performance of the CIRCA Temperature Monitoring System in detecting esophageal temperature changes as a result of energy delivery during cardiac ablation procedures has not been evaluated.

The CIRCA Scientific Temperature Monitoring System consists of a touch-screen monitor, interconnect cables, and an esophageal temperature probe. The monitor displays 12 temperature probe sensor readings (°C), the minimum and maximum temperature of all sensors, and contains an alarm system with userselected levels. The measured temperatures can be stored in the internal memory of the device and examined at a later time on an external personal computer (after exporting the corresponding data file to an USB flash drive). The S-CATH M Esophageal Temperature Probe provides continuous temperature measurement (℃) and operates in direct mode (operating mode of a clinical thermometer where the output temperature is an unadjusted temperature that represents the temperature of the measuring site to which the probe is coupled). The probe contains 12 thermistor sensors located along an s-curve. The sensors measure temperature by a resistor that is sensitive to temperature changes. The probe is connected to the CIRCA Scientific monitor by using an interconnect cable. The 10Fr diameter probe is placed inside the esophagus. The Probe is also equipped with 4 electrode sensors. By connecting the S-CATH M Probe to a 3D cardiac mapping system through the optional component Mapping Interconnect Cable, the probe can be visualized inside a 3D model of the patient's body for optimal placement.

The AtriAmp supports pacing by acting as an extension cable between an external pacemaker and cardiac pacing leads. The AtriAmp also supports monitoring of intra-cardiac signals to one of the unipolar precordial chest leads (leads V1-V6) of a Type CF, defibrillation-proof ECG monitor.

The AtriAmp acts as a connection hub for these three systems (external pacemaker, patient contacting external pacemaker lead wires and cardiac monitor) to provide a real-time, continuous atrial electrogram to the cardiac monitor while simultaneously allowing pacing of the atriAmp is a sterile, single patient use device.

Blackrock NeuroCoG Subdural Cortical Electrodes (Strips and Grids) are intended for temporary (<30 days) use with recording, monitoring, and stimulation equipment for the recording, and stimulation of electrical signals on the surface of the brain. The recording of electrical activity supports definition of the location of epileptogenic foci and brain mapping.

Cortical Electrode (Per FDA Classification)

The ESOTEST MULTI Temperature Monitoring System is composed of ESOTEST MULTI Monitor and ESOTEST MULTI Probe and is intended for the continuous detection, measurement and visualization (in °C) of esophageal temperature. The intended environments of use are operating rooms and interventional electrophysiology rooms. The ESOTEST MULTI Monitor must be used in conjunction with the ESOTEST MULTI Probe. The role of esophageal temperature monitoring using this device in reducing the risk of cardiac ablation-related esophageal injury has not been established. The performance of the ESOTEST MULTI system in detecting esophageal temperature changes as a result of energy delivery during cardiac ablation procedures has not been evaluated.

The device is composed of the following cleared (K180047) system components: - Monitor ESOTEST MULTI MONITOR - Esophageal probe ESOTEST MULTI PROBE - Patient cable ESOTEST MULTI PATIENT CABLE The Adapter cable ESOTEST MULTI ADAPTER CABLE has been added to the system. The ESOTEST MULTI MONITOR is a device for measuring the esophageal temperature through a sterile, single-use probe. This component, called ESOTEST MULTI PROBE, contains up to seven independent thermal sensors, each one consisting in T-type thermocouple soldered to a spherical steel electrode. The ESOTEST MULTI PATIENT CABLE connects the main unit of the monitor to the temperature probe and continuously converts to digital signals the analog voltages generated by the thermocouples. ESOTEST MULTI MONITOR is able to keep track of the esophageal temperature during clinical procedures which involve heating or cooling processes, with an accuracy of 0.3°C and a response time of 1s. The detected temperatures are visualized as numerical values, colored bars and scrolling plots. An integrated alarm system allows the operator to set 2 independent alarm thresholds, called "upper alarm threshold" and "lower alarm threshold". If any of the measured temperatures gets hotter than the upper threshold or colder than the lower threshold, ESOTEST MULTI MONITOR immediately emits sound and visual effects aimed at getting the attention of the operator. The measured temperatures and the alarm conditions can be stored in the internal memory of the device and examined at a later time on the monitor itself or on an external personal computer (after exporting the corresponding data to an USB mass storage device). By connecting the ESOTEST MULTI to a mapping system through the optional component ESOTEST MULTI ADAPTER CABLE, the probe sensors can be visualized inside a 3D model of the patient's body for optimal placement.

The Efficia CM10, CM12, CM100, CM120 and CM150 patient monitors are indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. The Efficia CM10, CM12, CM100, CM120 and CM150 patient monitors are intended for monitoring, analysis, recording and alarming of multiple physiological parameters in healthcare environments for patient types listed below. Additionally, the monitor may be used in transport situations within a healthcare facility. Parameter (patient types): ECG (Adult, Pediatric, Neonatal); Respiration - Impedance (Adult, Pediatric, Neonatal); Respiration - RRa (Adult); Respiration - awRR (Adult, Pediatric, Neonatal); NBP (Adult, Pediatric, Neonatal); SpO2 (Adult, Pediatric, Neonatal); SpHb (Adult, Pediatric); SpCO (Adult, Pediatric); Temperature (Adult, Pediatric, Neonatal); CO2 (Adult, Pediatric, Neonatal); IBP (Adult, Pediatric, Neonatal); Cardiac Output (Adult, Pediatric); Arrhythmia (Cardiotach) (Adult, Pediatric, Neonatal); Arrhythmia (Basic) (Adult, Pediatric); Arrhythmia (Advanced) (Adult, Pediatric); ST segment Analysis (Adult); Contraindications: Not for transport outside the healthcare facility

The subject Philips Efficia CM10, CM120 and CM150 patient monitors are a family of physiological vital signs monitors. The monitors come with a variety of display sized (10 inch, 12 inch or 15 inch) and with a variety of measurements, some optional. The monitors primarily run on AC power with a secondary battery. The exterior material is the same as the primary predicate devices.

Electrode/extension cable is intended to connect an electrode/lead from a patient or another cable to a diagnostic machine or an external pacemaker.

Electrode/Extension Cables, Models ATAR™