HAPPY HEALTH

FDA Device Registration & Listing · Austin, TX, US · Registration 3033715634

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3033715634
FEI Number
3033715634
Entity Name
HAPPY HEALTH
City/State/Country
Austin, TX, US
Establishment Address
3200 Gracie Kiltz Ln Ste 301, Austin, TX 78758, US
Establishment Type(s)
Manufacture Medical Device,Complaint File Establishment per 21 CFR 820.198
Owner / Operator
Happy Health (Owner Number: 10091422)
Owner / Operator Contact Address
3200 Gracie Kiltz Ln., Ste. 301, Austin, TX 78758, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K242224
PMA Number
N/A

All Registered Proprietary Names

Happy Ring Health Monitoring System Happy Health Home Sleep Test

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
DQA Oximeter Cardiovascular Class 2 870.2700 2024-10-03
GZO Device, Galvanic Skin Response Measurement Neurology Class 2 882.1540 2024-10-03
MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) Cardiovascular Class 2 870.2300 2024-10-03
BZQ Monitor, Breathing Frequency Anesthesiology Class 2 868.2375 2024-10-03
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2024-10-03
DRG Transmitters And Receivers, Physiological Signal, Radiofrequency Cardiovascular Class 2 870.2910 2024-10-03
LEL Device, Sleep Assessment Neurology Class 2 882.5050 2024-10-03
OMC Reduced- Montage Standard Electroencephalograph Neurology Class 2 882.1400 2025-12-03
MNR Ventilatory Effort Recorder Anesthesiology Class 2 868.2375 2025-12-03

Official Correspondent

David Carr

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Happy Health
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K903523 Hewlett-Packard Co. HP MODEL M1020A, ARTERIAL OXYGEN SAT/PLETH MODULE 1990-10-23
K973147 Nellcor Puritan Bennett, Inc. NPB-295 PULSE OXIMETER 1997-11-14
K231243 Guangdong Genial Technology Co., Ltd. Finger Clip Pulse Oximeter 2023-10-31
K971628 Somanetics Corp. SOMANETICS INVOS 3100A CEREBRAL OXIMETER (INVOS) 1997-10-10
K153184 Shenzhen Caremed Medical Technology Co., Ltd. Caremed Reusable & Disposable SPO2 Sensors 2017-01-04

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0020-2019 Oridion Medical 1987 Ltd. Har Hotzvim Industrial 2
CAPNOSTREAM 20 (US) N, Part Number CS08651
Z-0022-2019 Oridion Medical 1987 Ltd. Har Hotzvim Industrial 2
CAPNOSTREAM 20P (US) N - ROHS, Part Number CS08651-02
Z-0023-2019 Oridion Medical 1987 Ltd. Har Hotzvim Industrial 2
CAPNOSTREAM 20P (US) N - ROHS, Part Number CS08651-03
Z-0028-2019 Oridion Medical 1987 Ltd. Har Hotzvim Industrial 2
Capnostream20 (US) M, Part Number CS08653
Z-0029-2019 Oridion Medical 1987 Ltd. Har Hotzvim Industrial 2
Capnostream20 (US) M W/PRINTER, Part Number CS08659

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3033715634. Last updated year: 2026. Please use registration number 3033715634 when referencing this establishment in official correspondence.
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