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Incident · Regulatory action

Happy Ring earns second FDA clearance for at-home sleep testing

The FDA's K242224 record states that the Happy Health Home Sleep Test received 510(k) clearance on June 18, 2025. The software uses compatible wearable data to support evaluation of adult sleep apnea in clinical and home settings under healthcare-provider direction (FDA K242224).

Occurred 2026-06-15 · Happy Ring at United States (multiple hotel chains) · Happy Health · United States (multiple hotel chains) · Biometric wearables · Investigated by FDA

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Sources (2)

  1. https://www.accessdata.fda.gov/cdrh_docs/pdf24/K242224.pdf · 2025-06-18
  2. https://www.prnewswire.com/news-releases/happy-ring-earns-second-fda-clearancenow-approved-for-at-home-sleep-testing-to-simplify-the-diagnosis-and-treatment-of-sleep-apnea-and-related-health-conditions-302486269.html

Status history

  • Active · 2026-07-03 · agent:depth

Common questions

What happened in Happy Ring earns second FDA clearance for at-home sleep testing?
The FDA's K242224 record states that the Happy Health Home Sleep Test received 510(k) clearance on June 18, 2025. The software uses compatible wearable data to support evaluation of adult sleep apnea in clinical and home settings under healthcare-provider direction ([FDA K242224](https://www.accessdata.fda.gov/cdrh_docs/pdf24/K242224.pdf)).
When did this incident occur?
The incident is recorded as occurring on June 15, 2026 on the DEPLOY registry. The date reflects the underlying real-world event, not the registry record's creation date.
What robot was involved in Happy Ring earns second FDA clearance for at-home sleep testing?
Happy Ring by Happy Health is the recorded robot involved in this incident at United States (multiple hotel chains).
Has anyone responded to Happy Ring earns second FDA clearance for at-home sleep testing?
No responses to this incident are recorded on the DEPLOY registry. Operators, manufacturers, or affected parties can submit responses to the editorial team; absence is not a guarantee no response was issued.
What is the current status of Happy Ring earns second FDA clearance for at-home sleep testing?
This incident is an active record on the DEPLOY registry; no retraction or correction has been issued.
Methodology: Verified · 2 sources (1 primary) · last reviewed 2026-09-29

Verification posture

Verified

High confidence

Review state

Stable

Last reviewed 2026-09-29

Sources by quality tier

1
primary-fda-database
FDA database
1
unclassified
Unclassified source

The framework is documented at /methodology. Corrections at /corrections. Reviewer: DEPLOY editorial team.

Methodology surface for Happy Ring earns second FDA clearance for at-home sleep testing.

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Canonical ID 51e9bf16-6d43-4ad4-87c9-eda4b2282ac5