HUMA 1002

GUDID G2871002

The Huma platform is a modular Software as a Medical Device (SaMD) which may utilise compatible devices and software to obtain data collated via a mobile app or web app and delivered to the clinician via a web portal or web app where it may be viewed to drive clinical management. It is intended to be used for the physiological and non-physiological intermittent or spot-check monitoring of all condition patients in professional healthcare facilities, such as clinics, hospitals or skilled nursing facilities, or in the patient’s home setting. It is intended for the monitoring of patients by trained healthcare professionals. The Huma platform comprises a number of different modules and functionalities that can be selected by the customer for configuration of care plans which can be further personalised for the patients. Clinical information collected from these modules is displayed on a clinician web portal and patient app with the addition of flagging out of range datasets, trend visualisation, goal setting and communication channels between clinicians and patients.

MedoPad Inc.

Self-care monitoring/reporting software

• Primary Device ID: G2871002
• NIH Device Record Key: 2aae63b2-ad79-42bf-97d0-cf87485da1c4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HUMA
• Version Model Number: 1.34
• Catalog Number: 1002
• Company DUNS: 081267503
• Company Name: MedoPad Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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: false
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 801-673-9973
• Email: mani.shanmugham@huma.com
• Phone: 801-673-9973
• Email: mani.shanmugham@huma.com
• Phone: 801-673-9973
• Email: mani.shanmugham@huma.com
• Phone: 801-673-9973
• Email: mani.shanmugham@huma.com
• Phone: 801-673-9973
• Email: mani.shanmugham@huma.com
• Phone: 801-673-9973
• Email: mani.shanmugham@huma.com
• Phone: 801-673-9973
• Email: mani.shanmugham@huma.com
• Phone: 801-673-9973
• Email: mani.shanmugham@huma.com
• Phone: 801-673-9973
• Email: mani.shanmugham@huma.com
• Phone: 801-673-9973
• Email: mani.shanmugham@huma.com
• Phone: 801-673-9973
• Email: mani.shanmugham@huma.com
• Phone: 801-673-9973
• Email: mani.shanmugham@huma.com
• Phone: 801-673-9973
• Email: mani.shanmugham@huma.com
• Phone: 801-673-9973
• Email: mani.shanmugham@huma.com
• Phone: 801-673-9973
• Email: mani.shanmugham@huma.com
• Phone: 801-673-9973
• Email: mani.shanmugham@huma.com
• Phone: 801-673-9973
• Email: mani.shanmugham@huma.com
• Phone: 801-673-9973
• Email: mani.shanmugham@huma.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	G2871002 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K230214

FDA Product Code

• MWI: Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)

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: 2025-05-06
• Device Publish Date: 2025-04-28