EnsoTherapy

GUDID 00864458000421

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.

ENSODATA, INC.

Vulnerable patient home-monitoring software, professional-only

• Primary Device ID: 00864458000421
• NIH Device Record Key: 6de7f374-b820-453f-835c-7e64ac51dd15
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EnsoTherapy
• Version Model Number: 6.0
• Company DUNS: 080743964
• Company Name: ENSODATA, INC.
• 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: true
• Lot Batch: true
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00864458000421 [Primary]

FDA Product Code

• OUG: Medical Device Data System

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: 2023-11-28
• Device Publish Date: 2023-11-20

Devices Manufactured by ENSODATA, INC.

• 00864458000469 - EnsoSleep PPG: 2025-04-22 Sleep quality and sleep disordered breathing detection from pulse oximeters. Marketed as EnsoSleep PPG or Aurora
• 00864458000476 - EnsoSleep: 2025-04-22 Automated sleep study scoring and report generation by EnsoData
• 00864458000445 - EnsoSleep PPG: 2025-04-15 Sleep quality and sleep disordered breathing detection from pulse oximeters. Marketed as EnsoSleep PPG or Aurora
• 00864458000452 - Celeste+: 2025-04-15 Mobile app for recording breath sounds and snoring during sleep, along with file transfer from Bluetooth sleep recording devices
• 00864458000414 - EnsoSleep: 2024-03-04
• 00864458000421 - EnsoTherapy: 2023-11-28EnsoTherapy 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.
• 00864458000421 - EnsoTherapy: 2023-11-28 EnsoTherapy is a clinical decision support (CDS)/Medical Device Data System (MDDS) non-medical device product that allows clinic
• 00864458000407 - EnsoSleep: 2019-12-11 Automated sleep scoring software.