DEVICE: MyNotifi Rx (00850023296023)
Device Identifier (DI) Information
MyNotifi Rx
Version 2
In Commercial Distribution
MyNotifi RX - small
MEDHAB, LLC
Version 2
In Commercial Distribution
MyNotifi RX - small
MEDHAB, LLC
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
Device Characteristics
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GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
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35818 | Bed/chair occupant movement pressure/vibration sensor |
An electrically-powered electronic sensing pad (pressure- or mechanical vibration-sensing) designed to be placed under a bed and/or chair occupant to detect and/or measure occupant movement related to activities such as sleep, wakefulness, and/or bed/chair exit. Some types are able to detect in addition occupant respiration and heart rates; and some types function with an alarm/alert/notification system to indicate unattended occupant attempt to vacate bed/chair.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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KQX | Goniometer, Ac-Powered |
FDA Premarket Submission
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
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No storage/handling found |
Clinically Relevant Size
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Device Record Status
7b04a838-5370-4282-9881-c5f937680352
September 13, 2023
2
September 24, 2020
September 13, 2023
2
September 24, 2020
Alternative and Additional Identifiers Additional Identifiers
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Unit of Use DI
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Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
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No Customer Contact currently defined