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FDA 510(k)

Happy Health Blood Pressure Monitor

K-Number: K254000 · 2026-09-03

ApplicantHappy Health, Inc.
Decision Date2026-09-03
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Happy Health Blood Pressure Monitor is the device name listed in this FDA 510(k) record. The listed applicant is Happy Health, Inc.. It received FDA 510(k) clearance on 2026-09-03 under 510(k) number K254000. The device is classified under product code DXN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Happy Health Blood Pressure Monitor?

Happy Health Blood Pressure Monitor is a medical device that received FDA 510(k) clearance on 2026-09-03. The listed applicant is Happy Health, Inc.. The 510(k) number is K254000.

When did Happy Health Blood Pressure Monitor receive FDA 510(k) clearance?

Happy Health Blood Pressure Monitor received FDA 510(k) clearance on 2026-09-03, under 510(k) number K254000.

Who is the listed applicant for Happy Health Blood Pressure Monitor?

The FDA 510(k) record lists Happy Health, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Happy Health Blood Pressure Monitor?

The FDA product code for Happy Health Blood Pressure Monitor is DXN.

Other records listing Happy Health, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K242224Happy Health Home Sleep TestK240236Happy Ring Health Monitoring System

Related Devices (Code: DXN)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K262658Automatic Digital Blood Pressure monitor (LD-526)Honsun (Nantong) Co., Ltd.K261394Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-6186 Plus, DBP-6286B Plus, DBP-61E3 Plus, DBP-61E2 Plus, DBP-62E3B Plus, DBP-62E2B Plus)JOYTECH Healthcare Co., Ltd.K261061BP Go (BPP-855)Wellvii, Inc.K253425Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-6194-P,DBP-6294B-P,DBP-6195P,DBP-6295B-P, DBP-6196P,DBP-6296B-P,DBP-61E1-P, DBP-62E1B-P,DBP-62E3B-P,DBP-61E2-P,DBP-62E2B-P,DBP-61E3-P,DBP-6173-P,DBP-6273B-P,DBP-6179-P,DBP-6279B-P)Joytech Healthcare Co. , Ltd.K261136Blood Pressure Monitor (M501,M501A,M502,M502A,M502C,M502D)Guangzhou Daxin Health Technology Co., Ltd.K261082Microlife Wrist Blood Pressure Monitor , (Model BPHJG5-G)Microlife Corporation

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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