EnsoTherapy

Basic Information

• Brand Name: EnsoTherapy
• Primary DI: 00864458000421
• Version / Model: 6.0
• Company Name: Ensodata, Inc.
• Labeler DUNS: 080743964
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-11-20
• Public Version: 2
• Public Version Date: 2026-03-04
• Public Version Status: Update
• Public Device Record Key: 6de7f374-b820-453f-835c-7e64ac51dd15
• Distribution End Date: 2026-02-28

Device Description

EnsoTherapy is a clinical decision support (CDS)/Medical Device Data System (MDDS) non-medical device product that allows clinicians, clinical support staff, or administrators to identify and prioritize patients that could benefit from sleep disorder treatment adherence support. Treatment and communication data are imported into the software component, which is used to generate compliance projections, risk scores, and prioritized tasks for each patient. Information and tasks generated are used by clinicians in their decisions on how to prioritize patient coaching outreach.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
OUG	Medical Device Data System	General Hospital	880.6310	1

GMDN Terms

Code	Name	Definition	Implantable	Status
64242	Vulnerable patient home-monitoring software, professional-only	A software program intended to allow healthcare professionals to remotely observe and assess the physical/mental state and environment of a vulnerable/geriatric patient (e.g., patient with dementia) whilst at home. It is intended for real-time analysis and recording of data from devices in the home (motion sensors, medical monitoring equipment) and uses algorithms to highlight patterns of concerning behaviour or physiological readings. The data is intended to be reviewed remotely by a healthcare professional so that appropriate actions can be coordinated (e.g., contact next of kin, call paramedic). It is not intended for diagnosis.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00864458000421	GS1