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FDA 510(k)

Happy Ring Health Monitoring System

K-Number: K240236 · 2024-09-24

ApplicantHappy Health, Inc.
Decision Date2024-09-24
Product CodeMWI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Happy Ring Health Monitoring System is a medical device manufactured by Happy Health, Inc.. It received FDA 510(k) clearance on 2024-09-24 under approval number K240236. The device is classified under product code MWI. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Happy Ring Health Monitoring System?

Happy Ring Health Monitoring System is a medical device that received FDA 510(k) clearance on 2024-09-24. It is manufactured by Happy Health, Inc.. The 510(k) number is K240236.

When was Happy Ring Health Monitoring System approved by the FDA?

Happy Ring Health Monitoring System received FDA 510(k) clearance on 2024-09-24, under approval number K240236.

What company makes Happy Ring Health Monitoring System?

Happy Ring Health Monitoring System is manufactured by Happy Health, Inc..

What is the FDA product code for Happy Ring Health Monitoring System?

The FDA product code for Happy Ring Health Monitoring System is MWI.

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Related PubMed Literature

PMID: 42174947 Aligning AI-Native 6G Healthcare Systems with EU Ethical and Legal Frameworks. Studies in health technology and informatics (2026) 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: 41887630 Capacity building for ethical use of artificial intelligence in health: protocol for a scoping review of training initiatives and gaps in Africa. BMJ open (2026) PMID: 41879133 Medical Device Regulation - Who Does the FDA Serve? The Journal of law, medicine & ethics : a journal of the American Society of Law, Medicine & Ethics (2026)

Other Devices by Happy Health, Inc.

K242224Happy Health Home Sleep Test

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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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