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myrecovery, myrecovery App & Dashboard, myrecovery Patient Engagement & Outcomes

FDA UDI

Class I (US FDA UDI)

by Future Health Works Ltd

Identity

Trade Name
myrecovery, myrecovery App & Dashboard, myrecovery Patient Engagement & Outcomes FDA UDI
Generic Name
Configurable electronic form web-based application software FDA UDI
Device Name
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. FDA UDI
Model / Reference
MD FDA UDI
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. FDA UDI

Identifiers

Primary DI / UDI-DI
G333OUG001 FDA UDI
FDA Product Code
OUG FDA UDI
GMDN Term
Configurable electronic form web-based application software FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
880.6310 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Configurable electronic form web-based application software

myrecovery, myrecovery App & Dashboard, myrecovery Patient Engagement & Outcomes by Future Health Works Ltd — Class I — FDA UDI — listed in FDA GUDID

Similar devices

Also classified as Configurable electronic form web-based application software.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Future Health Works Ltd

Sources (1)

  • FDA UDI 16719383-6c57-4f5d-a800-e5cb2335b2dc 33 fields · synced Jun 8, 2026