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EnsoTherapy

FDA UDI

Class I (US FDA UDI)

by Ensodata, Inc.

Identity

Trade Name
EnsoTherapy FDA UDI
Generic Name
Vulnerable patient home-monitoring software, professional-only FDA UDI
Device Name
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. FDA UDI
Model / Reference
6.0 FDA UDI
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. FDA UDI

Identifiers

Primary DI / UDI-DI
00864458000421 FDA UDI
FDA Product Code
OUG FDA UDI
GMDN Term
Vulnerable patient home-monitoring software, professional-only 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

Yes

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

Yes

FDA UDI

Category: Vulnerable patient home-monitoring software, professional-only

EnsoTherapy by Ensodata, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Vulnerable patient home-monitoring software, professional-only.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Ensodata, Inc.

Sources (1)

  • FDA UDI 6de7f374-b820-453f-835c-7e64ac51dd15 33 fields · synced May 31, 2026