MyNotifi Rx

Primary DI
00850023296023
Brand
MyNotifi Rx
Company
MEDHAB, LLC
Model
Version 2
Catalog number
MyNotifi RX - small
Device description
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
Published
2020-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
KQXGoniometer, Ac-Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KQXGoniometer, Ac-PoweredOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850023296023PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850023296023008500232960238500232960230850023296023

GMDN Terms#

Term, Definition table
TermDefinition
Bed/chair occupant movement sensorAn 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
107660874
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850023296009MyNotifi RxVersion 2MyNotifi RX - large2020-09-24
00850023296016MyNotifi RxVersion 2MyNotifi RX - medium2020-09-24
00850023296276RPM2 Rx7 Size (0)Shoe insole size 0 (women 7.0 to 8.5) (men 5.0 to 2020-09-23
00850023296283RPM2 Rx7 Size (00)Shoe insole size 00 (women 3.0 to 6.5)2020-09-23
00850023296290RPM2 Rx7 Size (01)Shoe insole size 1 (women 9.0 to 10.5) (men 7.0 to2020-09-23
00850023296306RMP2 Rx7 Size (1)Shoe insole size 1 (women 9.0 to 10.5) (men 7.0 to2020-09-23
00850023296313RPM2 Rx7 Size (12)Shoe insole size (12) (women 9.0 to 10.5) (men 7.02020-09-23
00850023296320RPM2 Rx7 Size (2)Shoe insole size 2 (women 11.0 to 12.5) (men 9.0 t2020-09-23
00850023296337RPM2 Rx7 Size (2-3)Shoe insole size (2-3) (women 11.0 to 12.5) (men 92020-09-23
00850023296344RPM2 Rx7 Size (3)Shoe insole size 3 (women 13.0 to 15.0) (men 11.0 2020-09-23
00850023296351RPM2 Rx7 Size (4)Shoe insole size 4 (men 13.0 to 15.0)2020-09-23
00850023296085STEPRITE7 Size (4)Shoe insole size 4 (men 13.0 to 15.0)2020-09-24
00850023296030STEPRITE7 Size (00)Shoe insole size 00 (women 3.0 to 6.5)2020-09-23
00850023296047STEPRITE7 Size (0)Shoe insole size 0 (women 7.0 to 8.5) (men 5.0 to 2020-09-23
00850023296054STEPRITE7 Size (1)Shoe insole size 1 (women 9.0 to 10.5) (men 7.0 to2020-09-23
00850023296061STEPRITE7 Size (2)Shoe insole size 2 (women 11.0 to 12.5) (men 9.0 t2020-09-23
00850023296160STEPRITE7 Size (3)Shoe insole size 3 (women 13.0 to 15.0) (men 11.0 2020-09-23
00867239000207STEPRITE7STEPRITE 002019-09-23
00867239000214STEPRITE7STEPRITE SIZE 02019-09-23
00867239000221STEPRITE7STEPRITE SIZE 12019-09-23

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