AccessGUDID - DEVICE: myrecovery, myrecovery App & Dashboard, myrecovery Patient Engagement & Outcomes (G333OUG001)

GUDID

Device Identifier (DI) Information

Brand Name: myrecovery, myrecovery App & Dashboard, myrecovery Patient Engagement & Outcomes
Version or Model: MD
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: FUTURE HEALTH WORKS LTD

Primary DI Number: G333OUG001
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 220521982 *Terms of Use

Device Description: A clinical information and medical device data system for patient engagement and monitoring of treatment outcomes that can be customised by healthcare professionals to match their treatment pathways. The system can be configured to have diagnostic functionality but does not allow or enable direct diagnosis. No decisive information for making a diagnosis can be provided by the system on its own and it cannot provide diagnosis by itself, nor does it perform as a clinician or provide an indicative diagnosis to the lay user.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
60065	Configurable electronic form web-based application software	An application software program designed as an Internet-based information system intended to replace paper forms by electronically collecting and recording all types of patient clinical information, investigation results, and treatment data. It is a generic system which can be used in healthcare by configuration of workflows, metadata, and data lifecycles; and by integration into electronic medical record (EMR) systems using standard protocols. The electronic forms are intended to provide predefined workflow, input, search, and display functionalities, typically to manage a particular treatment or condition [e.g., hyposensitization (allergy desensitization), cleft lip].	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OUG	Medical Device Data System

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 16719383-6c57-4f5d-a800-e5cb2335b2dc
Public Version Date: February 27, 2023
Public Version Number: 1
DI Record Publish Date: February 17, 2023