510(k) clearance

Happy Health Blood Pressure Monitor

FDA 510(k) source

510(k) number

K254000

Applicant

Happy Health, Inc.

Decision date

Sep 3, 2026

Date received

Dec 15, 2025

Decision

Substantially Equivalent

Clearance type

Traditional

Product code

DXN

Device type

System, Measurement, Blood-Pressure, Non-Invasive

Device class

Class II

Regulation

21 CFR 870.1130

Advisory committee

Cardiovascular

Statement or summary

Summary

Third party

N

Location

Austin, TX, US