Identity
- Trade Name
- Somryst™ FDA UDI
- Generic Name
- Mental health/function therapeutic software, screen-viewed FDA UDI
- Device Name
- Somryst is a prescription-only digital therapeutic intended to provide a neurobehavioral intervention (Cognitive Behavioral Therapy for Insomnia - CBT-I) in patients 22 years of age and older with chronic insomnia. Somryst treats chronic insomnia by improving a patient's insomnia symptoms. Somryst uses sleep restriction and consolidation, limiting the time a patient spends in bed to match the amount of time they sleep. This treatment technique can increase risks to some patients whose pathophysiology may be worsened. Because of this, it is not appropriate for everyone. FDA UDI
- Model / Reference
- 1 FDA UDI
- Description
- Somryst is a prescription-only digital therapeutic intended to provide a neurobehavioral intervention (Cognitive Behavioral Therapy for Insomnia - CBT-I) in patients 22 years of age and older with chronic insomnia. Somryst treats chronic insomnia by improving a patient's insomnia symptoms. Somryst uses sleep restriction and consolidation, limiting the time a patient spends in bed to match the amount of time they sleep. This treatment technique can increase risks to some patients whose pathophysiology may be worsened. Because of this, it is not appropriate for everyone. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10851580008255 FDA UDI
- 510(k) Number
- K191716 FDA UDI
- FDA Product Code
- PWE FDA UDI
- GMDN Term
- Mental health/function therapeutic software, screen-viewed FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.5801 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Mental health/function therapeutic software, screen-viewed
Somryst™ by Pear Therapeutics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Mental health/function therapeutic software, screen-viewed.
- AspyreRx — Better Therapeutics · Class II
- Somryst — Nox Medical ehf. · Class II
- Mahana IBS — Mahana Therapeutics, Inc. · Class II
- MamaLift Plus — Curio Digital Therapeutics, Inc. · Class II
- Rejoyn — Otsuka Pharmaceutical Development & Commercialization, Inc. · Class II
- Stanza — Swing Therapeutics, Inc. · Class II
- VRCogni — XR HEALTH IL LTD · Class II
- PursueCare RESET-O — HARVEST BIO LLC · Class II
Cleared under the same submission
K191716 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Pear Therapeutics, Inc.
Sources (1)
- FDA UDI e63e361f-c19b-4920-acc3-0c3439a7d9e2 34 fields · synced Jun 6, 2026