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FDA 510(k)

Happy Health Home Sleep Test

K-Number: K242224 · 2025-06-18

ApplicantHappy Health, Inc.
Decision Date2025-06-18
Product CodeMNR
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Happy Health Home Sleep Test is a medical device manufactured by Happy Health, Inc.. It received FDA 510(k) clearance on 2025-06-18 under approval number K242224. The device is classified under product code MNR. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Happy Health Home Sleep Test?

Happy Health Home Sleep Test is a medical device that received FDA 510(k) clearance on 2025-06-18. It is manufactured by Happy Health, Inc.. The 510(k) number is K242224.

When was Happy Health Home Sleep Test approved by the FDA?

Happy Health Home Sleep Test received FDA 510(k) clearance on 2025-06-18, under approval number K242224.

What company makes Happy Health Home Sleep Test?

Happy Health Home Sleep Test is manufactured by Happy Health, Inc..

What is the FDA product code for Happy Health Home Sleep Test?

The FDA product code for Happy Health Home Sleep Test is MNR.

Related Clinical Trials

NCT07520955 Lily's Grace Temporal Interference NOT_YET_RECRUITING NCT03288207 Tailoring Mobile Health Technology to Reduce Obesity and Improve Cardiovascular Health in Resource-Limited Neighborhood Environments RECRUITING NCT07171359 TMS to Improve Recovery Outcomes Among Patients With Opioid Use Disorder (OUD) and Alcohol Use Disorder (AUD) RECRUITING NCT07047092 Non-invasive Ventilation or CPAP in OSA-COPD Following Admission for an Acute Hypercapnic Respiratory Failure RECRUITING NCT07588659 Retail-Grade Weighted Blanket Effectiveness on ADHD-related Sleep Disturbances (BEAD) NOT_YET_RECRUITING NCT02703207 Neurocognitive and Health Impact of Sleep Apnea in Elderly Veterans With Comorbid COPD RECRUITING

Related PubMed Literature

PMID: 41429289 Clinical Evidence to Support US Food and Drug Administration Review of New Medical Technology in Pulmonary, Sleep, and Critical Care Medicine Between 2014 and 2024: A Scoping Review to Support Adoption in Practice. Chest (2026) PMID: 40290478 Mental health apps in India: regulatory landscape and future directions. BJPsych international (2025) PMID: 39821849 Efficacy of brief behavioral and sleep hygiene education with mindfulness intervention on sleep, social jetlag and mental health in adolescence: a pilot study. Sleep & breathing = Schlaf & Atmung (2025)

Other Devices by Happy Health, Inc.

K240236Happy Ring Health Monitoring System

Related Devices (Code: MNR)

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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.

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