The iNAP One Sleep Therapy System
K-Number: K220907 · 2023-06-16
ApplicantSomnics, Inc.
Decision Date2023-06-16
Product CodeOZR
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
The iNAP One Sleep Therapy System is a medical device manufactured by Somnics, Inc.. It received FDA 510(k) clearance on 2023-06-16 under approval number K220907. The device is classified under product code OZR. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the The iNAP One Sleep Therapy System?
The iNAP One Sleep Therapy System is a medical device that received FDA 510(k) clearance on 2023-06-16. It is manufactured by Somnics, Inc.. The 510(k) number is K220907.
When was The iNAP One Sleep Therapy System approved by the FDA?
The iNAP One Sleep Therapy System received FDA 510(k) clearance on 2023-06-16, under approval number K220907.
What company makes The iNAP One Sleep Therapy System?
The iNAP One Sleep Therapy System is manufactured by Somnics, Inc..
What is the FDA product code for The iNAP One Sleep Therapy System?
The FDA product code for The iNAP One Sleep Therapy System is OZR.
Related Clinical Trials
NCT01143558
Searching for Persistence of Infection in Lyme Disease
COMPLETED
NCT06011187
Assisted Fluid Management (AFM) System and Postoperative Outcome After High-risk Abdominal Surgery
COMPLETED
NCT05016219
Phase 2 - Rhythmic Light Therapy for Alzheimer's Disease Patients
RECRUITING
NCT03280862
DANISH-CRT - Does Electric Targeted LV Lead Positioning Improve Outcome in Patients With Heart Failure and Prolonged QRS
COMPLETED
NCT05701917
DEFIANCE: RCT of ClotTriever System Versus Anticoagulation In Deep Vein Thrombosis
RECRUITING
NCT07613476
Pregabalin Phonophoresis for Carpal Tunnel Syndrome Pain
ACTIVE_NOT_RECRUITING
Related PubMed Literature
PMID: 41966529
Comparison of the AccuPower HIV-1 Quant Kit and Aptima HIV-1 Quant Dx Assay for quantification of HIV-1 plasma viral load.
Diagnostic microbiology and infectious disease (2026)
PMID: 40942702
Digital Cardiovascular Twins, AI Agents, and Sensor Data: A Narrative Review from System Architecture to Proactive Heart Health.
Sensors (Basel, Switzerland) (2025)
PMID: 40624966
Peptide-Enhanced Bioactive Hydrogel Combined with Photodynamic-Phage Synergistic Antibacterial Therapy System Accelerates Infected Wound Healing.
Advanced healthcare materials (2025)
PMID: 40290478
Mental health apps in India: regulatory landscape and future directions.
BJPsych international (2025)
Other Devices by Somnics, Inc.
Related Devices (Code: OZR)
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.