HUMA

Primary DI
G2871002
Brand
HUMA
Company
MedoPad Inc.
Model
1.34
Catalog number
1002
Device description
The Huma platform is a modular Software as a Medical Device (SaMD) whichmay utilise compatible devices and software to obtain data collated via amobile app or web app and delivered to the clinician via a web portal or webapp where it may be viewed to drive clinical management. It is intended to beused for the physiological and non-physiological intermittent or spot-checkmonitoring of all condition patients in professional healthcare facilities, suchas clinics, hospitals or skilled nursing facilities, or in the patient’s homesetting. It is intended for the monitoring of patients by trained healthcareprofessionals.The Huma platform comprises a number of different modules andfunctionalities that can be selected by the customer for configuration of careplans which can be further personalised for the patients.Clinical information collected from these modules is displayed on a clinicianweb portal and patient app with the addition of flagging out of rangedatasets, trend visualisation, goal setting and communication channelsbetween clinicians and patients.
Published
2025-04-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MSXSystem, Network And Communication, Physiological Monitors
MWIMonitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MSXSystem, Network And Communication, Physiological MonitorsCardiovascular2
MWIMonitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)Cardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K230214000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K230214000Huma RPM (RPM)Medopad, Inc.2023-06-02MWI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G2871002PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Self-care monitoring/reporting softwareAn application software program designed for the continual collection and aggregation of a patient's self-care data to promote communication between patient and healthcare provider, to facilitate a patient's self-care by using rules defined during use of the application, and/or to facilitate population monitoring. It is typically used to capture clinical (e.g., blood pressure, weight, and blood glucose), nutritional, and/or exercise information in the home, which may include medication administration information captured from enabled injection devices and data from wearable devices, providing care plan, journal, medication advice, and/or messaging functionalities.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
801-673-9973mani.shanmugham@huma.com

Regulatory Flags#

DUNS number
081267503
Device count
1
Manufacturing date on label
true

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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