Happy Health

Basic Information

• Brand Name: Happy Health
• Primary DI: 00850068747092
• Version / Model: Happy Ring HR0601GB
• Company Name: HAPPY HEALTH, INC.
• Labeler DUNS: 117343786
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-04-02
• Public Version: 1
• Public Version Date: 2025-04-10
• Public Version Status: New
• Public Device Record Key: fde020ec-8334-45c7-8120-dc2152234778

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MWI	Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)	Cardiovascular	870.2300	2
BZQ	Monitor, Breathing Frequency	Anesthesiology	868.2375	2
DQA	Oximeter	Cardiovascular	870.2700	2
DRG	Transmitters And Receivers, Physiological Signal, Radiofrequency	Cardiovascular	870.2910	2
FLL	Thermometer, Electronic, Clinical	General Hospital	880.2910	2
GZO	Device, Galvanic Skin Response Measurement	Neurology	882.1540	2
LEL	Device, Sleep Assessment	Neurology	882.5050	2

GMDN Terms

Code	Name	Definition	Implantable	Status
65669	Multiple vital physiological parameter monitoring system, home-use	An assembly of electrically-powered devices designed to be used by a layperson in the home for intermittent or continuous assessment of several vital physiologic parameters [e.g., electrocardiogram (ECG), noninvasive blood pressure (NIBP), pulse rate, temperature, haemoglobin oxygen saturation (SpO2)]. It includes both physiological parameter sensors, probes, and/or electrodes (e.g., ECG electrodes, blood pressure cuff) and processing hardware with dedicated software. It typically incorporates a monitoring screen, but may alternatively be connected to an off-the-shelf device for display; it is not intended to be worn on the body.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850068747092	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K240236	000