Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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rebless™ (Model: RHBD) has been designed to provide a safe and efficient solution for individuals recovering after joint surgeries, injuries, neurological movement disorders improving range of motion, muscle strength, and enhancing overall physical performance. This device incorporates robotic and isokinetic technology, making it a versatile and essential tool for physical therapy clinics, sports medicine facilities, and home use. rebless™ (Model: RHBD) is a robotic, exercise therapy device for both upper and lower limbs, providing motion to the elbow, wrist, ankle, and knee joints. With multiple operating modes, rebless™ allows for passive and active-assisted range of motion and resisted exercise, so therapy can be customized based on each individual patient’s condition and progress. rebless™ is controlled through an app downloaded onto the patient’s smartphone or mobile device. rebless™ provides therapeutic treatment at home or in clinics for patients suffering from neurological or musculoskeletal conditions. Key features: 1) Isokinetic: The standout feature of rebless™ (Model: RHBD) device is its isokinetic functionality. Isokinetic exercise ensures that resistance remains constant throughout a range of motion, adapting to the user's force output. This capability is particularly valuable in rehab settings, allowing patients to exercise at a pace that suits their recovery and minimizing the risk of further injury. 2) Adjustable resistance: The device provides a wide range of adjustable resistance settings, accommodating to apply resistance level based on their abilities. This adaptability is crucial for progression in rehabilitation and training programs. 3) Adjustable assistance: The device provides a wide range of adjustable assistance settings, to apply assistance level based on their abilities. This adaptability is crucial for progression in rehabilitation and training programs.
H ROBOTICS INC.
RHDB
In Commercial Distribution

  • 08800101600183 ()
1

  • Continuous passive motion joint exerciser
Device Description: The GoSpiro® is intended to be used by adults and children over 5 years old in physician’s offices, clinics and home settings to conduct basic lung function and spirometry testing. It is a single-patient, use device. The GoSpiro spirometer transmits real-time lung function data to computers, tablets or smartphones over a Bluetooth connection for tele-healthcare applications. The GoSpiro performs full flow-volume loops including inspiratory and expiratory data. The internal program performs all of the calculations for measurements to meet American Thoracic Society and European Respiratory Society requirements. It has built-in quality control measurements and transmits indices of measurement quality including time to peak flow, back-extrapolated volume, total expiratory time, and end-expiratory flow detection. It is used with the GoSpiro App display and communications software on a smartphone or tablet. The GoSpiro is powered by an internal rechargeable Lithium battery and is charged via its USB charging station connected to a USB power source. The device complies with ES 60601-1, IEC 60601-1-2, and IEC 60601-1-11. The fundamental technology to measure flow is a vertical turbine volume sensor. The turbine transducer measures expired air directly at B.T.P.S. (body temperature and pressure with saturated water vapor) thus avoiding the requirement for temperature correction on exhalation. An electronic temperature sensor on the device PCB measures atmospheric temperature, thus enabling correction of inspired volumes and flows. This transducer is insensitive to the effects of condensation and temperature and avoids the need for individual calibration prior to performing a test. Indications for Use: The GoSpiro® is intended to be used by adults and children over 5 years old in physician’s offices, clinics and home settings to conduct basic lung function and spirometry testing. It is a single-patient use device.
MONITORED THERAPEUTICS, INC.
45-90058
In Commercial Distribution

  • 00860000692809 ()
45-90058

  • Diagnostic spirometer, professional
MyNotifiRX: Is a Bluetooth wearable device that interacts with a patient’s smart phone via an app (iOS or android). All data is sent by wifi to a HIPAA controlled server for real time or accumulated time review by the provider. MyNotifiRX can be used to meet the rehabilitation needs of any extremity after injury. It can be used both pre and post-operatively to meet a patient’s rehabilitation needs. It is designed for acute or chronic use especially in patients at high risk for falls. As an added feature it is designed with a fall detection algorithm to alert designated care givers in the case of an emergency independent of a patient’s ability to respond. It is designed with two functions. 1) In patients who are evaluated to be at risk for falls, MyNotifi can act as a Fall protection device and monitor. It has a built in algorithm to detect when a possible fall occurs and alerts those that the wearer has designated that an issue has occurred. It is also imbedded with the OTAGO exercise protocol https://www.apta.org/PTinMotion/NewsNow/?blogid=10737418615&id=10737430053 ) which is clinically proven to help prevent falls by improving balance. Long term remote monitoring of patients to assist, adjust, advance or correct exercise regimen is possible. Even more important, it can serve as a means to catch early deterioration of function and signal the need for intervention before an accident occurs. 2) With its magnetic strip and extension band, it can be placed on any extremity to record an exercise regimen programmed by the provider. There is a library of over 40 APTA exercises (attach sheet) that can be selected. It is recommended for use in upper extremity patients for both nonoperative and post-operative rehabilitation. MyNotifi is best suited in the lower extremity for the rehab of non surgical patients. The addition of a monitor to measure heart rate and blood oxygenation during exercise adds to patient safety and serves as a measure of physical exertion during
MEDHAB, LLC
Version 2
In Commercial Distribution

  • 00850023296023 ()
MyNotifi RX - small

  • Bed/chair occupant movement pressure/vibration sensor
MyNotifiRX: Is a Bluetooth wearable device that interacts with a patient’s smart phone via an app (iOS or android). All data is sent by wifi to a HIPAA controlled server for real time or accumulated time review by the provider. MyNotifiRX can be used to meet the rehabilitation needs of any extremity after injury. It can be used both pre and post-operatively to meet a patient’s rehabilitation needs. It is designed for acute or chronic use especially in patients at high risk for falls. As an added feature it is designed with a fall detection algorithm to alert designated care givers in the case of an emergency independent of a patient’s ability to respond. It is designed with two functions. 1) In patients who are evaluated to be at risk for falls, MyNotifi can act as a Fall protection device and monitor. It has a built in algorithm to detect when a possible fall occurs and alerts those that the wearer has designated that an issue has occurred. It is also imbedded with the OTAGO exercise protocol https://www.apta.org/PTinMotion/NewsNow/?blogid=10737418615&id=10737430053 ) which is clinically proven to help prevent falls by improving balance. Long term remote monitoring of patients to assist, adjust, advance or correct exercise regimen is possible. Even more important, it can serve as a means to catch early deterioration of function and signal the need for intervention before an accident occurs. 2) With its magnetic strip and extension band, it can be placed on any extremity to record an exercise regimen programmed by the provider. There is a library of over 40 APTA exercises (attach sheet) that can be selected. It is recommended for use in upper extremity patients for both nonoperative and post-operative rehabilitation. MyNotifi is best suited in the lower extremity for the rehab of non surgical patients. The addition of a monitor to measure heart rate and blood oxygenation during exercise adds to patient safety and serves as a measure of physical exertion during
MEDHAB, LLC
Version 2
In Commercial Distribution

  • 00850023296016 ()
MyNotifi RX - medium

  • Bed/chair occupant movement pressure/vibration sensor
MyNotifiRX: Is a Bluetooth wearable device that interacts with a patient’s smart phone via an app (iOS or android). All data is sent by wifi to a HIPAA controlled server for real time or accumulated time review by the provider. MyNotifiRX can be used to meet the rehabilitation needs of any extremity after injury. It can be used both pre and post-operatively to meet a patient’s rehabilitation needs. It is designed for acute or chronic use especially in patients at high risk for falls. As an added feature it is designed with a fall detection algorithm to alert designated care givers in the case of an emergency independent of a patient’s ability to respond. It is designed with two functions. 1) In patients who are evaluated to be at risk for falls, MyNotifi can act as a Fall protection device and monitor. It has a built in algorithm to detect when a possible fall occurs and alerts those that the wearer has designated that an issue has occurred. It is also imbedded with the OTAGO exercise protocol https://www.apta.org/PTinMotion/NewsNow/?blogid=10737418615&id=10737430053 ) which is clinically proven to help prevent falls by improving balance. Long term remote monitoring of patients to assist, adjust, advance or correct exercise regimen is possible. Even more important, it can serve as a means to catch early deterioration of function and signal the need for intervention before an accident occurs. 2) With its magnetic strip and extension band, it can be placed on any extremity to record an exercise regimen programmed by the provider. There is a library of over 40 APTA exercises (attach sheet) that can be selected. It is recommended for use in upper extremity patients for both nonoperative and post-operative rehabilitation. MyNotifi is best suited in the lower extremity for the rehab of non surgical patients. The addition of a monitor to measure heart rate and blood oxygenation during exercise adds to patient safety and serves as a measure of physical exertion du
MEDHAB, LLC
Version 2
In Commercial Distribution

  • 00850023296009 ()
MyNotifi RX - large

  • Bed/chair occupant movement pressure/vibration sensor
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