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

GUDID G333KQX001

A clinical information system with a digital goniometer. 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.

FUTURE HEALTH WORKS LTD

Electronic goniometer/kinesiology sensor

• Primary Device ID: G333KQX001
• NIH Device Record Key: 8e6750bc-adec-4497-969d-e87a49bdcb85
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: myrecovery, myrecovery App & Dashboard, myrecovery Patient Engagement & Outcomes
• Version Model Number: MD
• Company DUNS: 220521982
• Company Name: FUTURE HEALTH WORKS LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	G333KQX001 [Primary]

FDA Product Code

• KQX: Goniometer, Ac-Powered

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-02-27
• Device Publish Date: 2023-02-17

On-Brand Devices [myrecovery, myrecovery App & Dashboard, myrecovery Patient Engagement & Outcomes]

• G333OUG001: A clinical information and medical device data system for patient engagement and monitoring of t
• G333KQX001: A clinical information system with a digital goniometer. The system can be configured to have di