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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
actiTENS is a transcutaneous electrical nerve stimulation (TENS) medical device designed to manage chronic pain.
The compact design and flexible shape of the actiTENS electrical impulse generator allows to fix it for daily use directly to the body of the patient.
The impulse generator is delivered with a separate cradle which allows safely recharging its non- removable battery.
The actiTENS is compatible with a selection of disposable electrodes and compatible connector cables transmit the electrical stimulation impulses to the targeted nerves according to the selected therapy. The electrical stimulation waveforms are biphasic and asymmetric.
The actiTENS is controlled via a downloadable mobile app which allows the comfortable and simple selection of the adequate stimulation program.
The actiTENS is intended to be used by the patient at home and also for therapeutic application by medical professionals.
It is available for prescription only.
SUBLIMED
actiTENS standard kit
In Commercial Distribution
- 03770018808239 ()
SBM1AA018
- Analgesic transcutaneous electrical nerve stimulation system
actiTENS is a transcutaneous electrical nerve stimulation (TENS) medical device designed to manage chronic pain.
The compact design and flexible shape of the actiTENS electrical impulse generator allows to fix it for daily use directly to the body of the patient.
The impulse generator is delivered with a separate cradle which allows safely recharging its non- removable battery.
The actiTENS is compatible with a selection of disposable electrodes and compatible connector cables transmit the electrical stimulation impulses to the targeted nerves according to the selected therapy. The electrical stimulation waveforms are biphasic and asymmetric.
The actiTENS is controlled via a downloadable mobile app which allows the comfortable and simple selection of the adequate stimulation program.
The actiTENS is intended to be used by the patient at home and also for therapeutic application by medical professionals.
It is available for prescription only.
SUBLIMED
actiTENS
In Commercial Distribution
- B786SBM1AA1100 ()
SBM1AA110
- Analgesic transcutaneous electrical nerve stimulation system
actiTENS is a transcutaneous electrical nerve stimulation (TENS) medical device designed to manage chronic pain.
The compact design and flexible shape of the actiTENS electrical impulse generator allows to fix it for daily use directly to the body of the patient.
The impulse generator is delivered with a separate cradle which allows safely recharging its non- removable battery.
The actiTENS is compatible with a selection of disposable electrodes and compatible connector cables transmit the electrical stimulation impulses to the targeted nerves according to the selected therapy. The electrical stimulation waveforms are biphasic and asymmetric.
The actiTENS is controlled via a downloadable mobile app which allows the comfortable and simple selection of the adequate stimulation program.
The actiTENS is intended to be used by the patient at home and also for therapeutic application by medical professionals.
It is available for prescription only.
SUBLIMED
actiTENS standard kit
In Commercial Distribution
- B786SBM1AA0170 ()
SBM1AA017
- Analgesic transcutaneous electrical nerve stimulation system
Expand your communication options with a set of three BIG TalkingBrix speech devices. Pressing the large colored top plays a single message up to 10-seconds long. Use individually or connect to make a multi-message speech device.
Includes ableCARE on-demand support
Built ableSTRONG to endure drops and other environmental conditions
Made from ableSAFE materials and tested by third-party safety labs
Common Uses
Add strategically around the classroom or home to provide on-the-spot communication
Use together to make choices
Use with multiple individuals at one time to provide each with a unique communication message
Features
High-quality sound suitable for almost any environment
Long-lasting rechargeable battery
Clear snap cover to attach picture symbols and provide communication context to the user
Symbol Overlays
Symbol overlays are not included with the BIG TalkingBrix. Download the free AbleNet Symbol Overlay app for iPad to create symbol overlays for your AbleNet speech device
Ablenet, Inc.
10000050
In Commercial Distribution
- 00850011150184 ()
10000050
- Assistive speech generator
Expand your communication options with a set of three TalkingBrix 2 speech devices. Pressing the colored top plays a single message up to 10-seconds long. Use individually or connect to make a multi-message speech device.
Includes ableCARE on-demand support
Built ableSTRONG to endure drops and other environmental conditions
Made from ableSAFE materials and tested by third-party safety labs
Common Uses
Add strategically around the classroom or home to provide on-the-spot communication
Use together to make choices
Use with multiple individuals at one time to provide each with a unique communication message
Features
High-quality sound suitable for almost any environment
Long-lasting rechargeable battery
Clear snap cover to attach picture symbols and provide communication context to the user
Symbol Overlays
Symbol overlays are not included with the TalkingBrix2. Download the free AbleNet Symbol Overlay app for iPad to create symbol overlays for your AbleNet speech device.
Ablenet, Inc.
10000032
In Commercial Distribution
- 00186648000524 ()
10000032
- Assistive speech generator
Alleye® is a vision function test provided on a commercially available mobile phone. Alleye® implements an alignment hyperacuity task which helps patients with age-related macular degeneration (AMD) to assess their vision at home. This allows the timely detection of significant changes in vision function, enabling the regular monitoring of the disease progression and/or verifying the efficacy of ongoing treatments. Alleye is a digital technology, consisting of two different items: a mobile app for patients and a web interface for eye care professionals. Principle of Operation The test consists of 12 tasks that are performed on the user’s mobile phone. For each task, two dots are placed at each extremity of an invisible axis. A third dot is placed between these two dots, 40 pixels above or 40 pixels below the axis. The test consists in aligning the three dots by moving the dot in the middle. A single click on the up and down buttons moves the dot by 0.3 pixels up or down, respectively. If the patient maintains their finger on the buttons, the dot keeps moving. When it reaches a limit of 50 pixels away from its ideal position on the axis, the dot automatically stops. Once the user is satisfied with the position of the middle dot, they confirm it by tapping the circle button between the two arrow buttons. Overall, the patient must perform three alignments on four different axes (horizontal, vertical, oblique upper left / lower right, and oblique upper right / lower left). The test is performed on one eye only. The eye that is not being tested must be covered before starting the test. The TRAINING mode allows the patient to learn how to use the app, without recording the score results. To start the test, the patient must select TEST, and then select the eye (RIGHT or LEFT) to be tested. The Alleye tasks will proceed until COMMENT ON TEST appears on the screen. The patient can select REPEAT to start the test again, or DONE to save the test and display the results.
OCULOCARE medical AG
3.2.12
In Commercial Distribution
- EOMA32120 ()
- Vision self-testing software
The easiest way to provide an individual with two side-by-side communication choices is with the iTalk2 speech device. Activate the red or yellow top to play the desired message. New messages are easily and quickly recorded to the iTalk2 on the fly, or use the levels pre-record up to three sets of messages ahead of time.
Includes ableCARE on-demand support
Built ableSTRONG to endure drops and other environmental conditions
Made from ableSAFE materials and tested by third-party safety labs
Common Uses
Use for yes and no responses
Choose between two options of food, drink, or activities
Provide a way to make two unique requests like "I need help" and "I'm done"
Features
Better than ever digital sound output suitable for almost any environment
Clear snap cover to attach picture symbols and provide communication context to the user
Soft-touch coating makes the device easier to hold
Symbol Overlays
Symbol overlays are not included with the iTalk2. Download the free AbleNet Symbol Overlay app for iPad to create symbol overlays for your AbleNet speech device.
Ablenet, Inc.
10000045
In Commercial Distribution
- 00850011150108 ()
10000045
- Assistive speech generator
The easiest way to provide an individual with four side-by-side communication choices is with the iTalk4 speech device. Activate the colored top to play the desired message. New messages are easily and quickly recorded to the iTalk4 on the fly, or use the levels pre-record up to three sets of messages ahead of time.
Includes ableCARE on-demand support
Built ableSTRONG to endure drops and other environmental conditions
Made from ableSAFE materials and tested by third-party safety labs
Common Uses
Provide a unique response to a question like "What is the weather like outside?"
Respond to an assessment
Provide a way to make unique requests like "I need help", "I'm done", "I need to use the bathroom", and "I'm thirsty"
Add communication to a switch controlled toy or appliance
Features
Better than ever digital sound output suitable for almost any environment
Clear snap cover to attach picture symbols and provide communication context to the user
Symbol Overlays
Symbol overlays are not included with the iTalk4. Download the free AbleNet Symbol Overlay app for iPad to create symbol overlays for your AbleNet speech device.
Ablenet, Inc.
10000028
In Commercial Distribution
- 00186648000531 ()
10000028
- Assistive speech generator