FDA 510(k) · Happy Health
K240236: Happy Ring Health Monitoring System (Happy Health, Inc.)
Happy Health, Inc. received FDA 510(k) K240236 for Happy Ring Health Monitoring System, with a decision date of Sep 24, 2024 (substantially equivalent).
Prescription or OTC: Unknown (no FDA document we parsed states it).
FDA facts
| FDA number | K240236 |
|---|---|
| Pathway | 510(k) |
| Applicant | Happy Health, Inc. |
| Device name | Happy Ring Health Monitoring System |
| Product code | MWI: Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) |
| Regulation (21 CFR) | 870.2300 |
| Device class | Class 2 |
| Date received | Jan 29, 2024 |
| Decision date | Sep 24, 2024 |
| Decision | Substantially Equivalent (SESE) |
| 510(k) type | Traditional |
Source: openFDA device 510(k) data, data through Oct 26, 2026.
Indications for use parsed from FDA documents
The Happy Ring Health Monitoring System is a wearable device system to remotely monitor physiologic parameters of patients in professional healthcare facilities, such as hospitals or skilled nursing facilities, or their own home. The device is intended for use on individuals who are 22 years of age or older. The device supports continuous data collection for monitoring of the following physiological parameters: * Acceleration / Movement * Electrodermal Activity (EDA) * Blood Oxygen Saturation * Pulse Rate * Peripheral Skin Temperature The Happy Ring Health Monitoring System is intended for peripheral skin temperature monitoring, where monitoring temperature at the finger is clinically indicated. The Happy Ring Health Monitoring System is not intended for SpO2, pulse rate, respiration rate monitoring in conditions of motion or low perfusion.
Extracted automatically from FDA's 510(k) summary with OCR. It can contain extraction errors and is not a verified quote. Read the wording in the FDA PDF before relying on it.
Predicates parsed from FDA documents
FDA numbers found next to the word "predicate" in the summary. The list can include reference devices; check the PDF for which device is the primary predicate.
- K230457 Empatica Health Monitoring Platform; Em… (Empatica)
Later records that cite K240236
- K242224 Happy Health Home Sleep Test (Happy Health, Jun 18, 2025, MNR)
ChatPPG interpretation
A 510(k) decision of "substantially equivalent" means FDA found the device as safe and effective as a legally marketed predicate. FDA's word for this is cleared, not approved. The clearance covers the device and indications in this submission; it does not extend to other features or versions of the same product that were not part of it. See FDA cleared vs approved.
Product code MWI is "Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)", class 2, 21 CFR 870.2300.
Our labels for filtering: claim Remote / vital-sign monitoring, sensor Ring PPG. These are heuristics, not FDA fields.