# K240236: Happy Ring Health Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Happy Health, Inc.
- Decided: Sep 24, 2024 after 239 days
- Product code: MWI (Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms))
- Device class: 2
- Regulation: 21 CFR 870.2300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 40 generations back to K941811 (1994). 414 ancestors in all.
No later device cites it as a predicate yet.
2 of 415 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K230457: Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care Portal, Empatica S.r.l. (2023) Summary page 5.

## Indications for use
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.

Source page: https://510kreport.com/device/K240236
Methodology: https://510kreport.com/methodology