Happy Ring Health Monitoring System— 510(k) K240236
Substantially EquivalentHappy Health, Inc.
FDA 510(k) clearance K240236 for Happy Ring Health Monitoring System, Substantially Equivalent on 2024-09-24. Applicant: Happy Health, Inc..
Clearance details
- Applicant
- Happy Health, Inc.
- Product code
- Code MWI
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Austin, TX, US
Adverse events under product code MWI
product code MWI- Death
- 16
- Malfunction
- 963
- Total
- 979
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.