Cleared Traditional

Happy Ring Health Monitoring System

K240236 · Happy Health, Inc. · Cardiovascular

Sep 2024

Decision

239d

Days

Class 2

Risk

About This 510(k) Submission

K240236 is an FDA 510(k) clearance for the Happy Ring Health Monitoring System, a Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) (Class II — Special Controls, product code MWI), submitted by Happy Health, Inc. (Austin, US). The FDA issued a Cleared decision on September 24, 2024, 239 days after receiving the submission on January 29, 2024. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2300.

Submission Details

510(k) Number	K240236 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 29, 2024
Decision Date	September 24, 2024
Days to Decision	239 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF

Device Classification

Product Code	MWI — Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms)
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 870.2300