Happy Health

GUDID 00850068747108

HAPPY HEALTH, INC.

Multiple vital physiological parameter monitoring system, home-use

• Primary Device ID: 00850068747108
• NIH Device Record Key: 9f0f5407-8a66-449d-9ce3-32c9f0e61f80
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Happy Health
• Version Model Number: Happy Ring HR0701GB
• Company DUNS: 117343786
• Company Name: HAPPY HEALTH, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 8177348303
• Email: rakesh@rxdeviceconsulting.com
• Phone: 8177348303
• Email: rakesh@rxdeviceconsulting.com
• Phone: 8177348303
• Email: rakesh@rxdeviceconsulting.com
• Phone: 8177348303
• Email: rakesh@rxdeviceconsulting.com
• Phone: 8177348303
• Email: rakesh@rxdeviceconsulting.com
• Phone: 8177348303
• Email: rakesh@rxdeviceconsulting.com
• Phone: 8177348303
• Email: rakesh@rxdeviceconsulting.com
• Phone: 8177348303
• Email: rakesh@rxdeviceconsulting.com
• Phone: 8177348303
• Email: rakesh@rxdeviceconsulting.com
• Phone: 8177348303
• Email: rakesh@rxdeviceconsulting.com
• Phone: 8177348303
• Email: rakesh@rxdeviceconsulting.com
• Phone: 8177348303
• Email: rakesh@rxdeviceconsulting.com
• Phone: 8177348303
• Email: rakesh@rxdeviceconsulting.com
• Phone: 8177348303
• Email: rakesh@rxdeviceconsulting.com
• Phone: 8177348303
• Email: rakesh@rxdeviceconsulting.com
• Phone: 8177348303
• Email: rakesh@rxdeviceconsulting.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850068747108 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K240236

FDA Product Code

• MWI: Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-04-10
• Device Publish Date: 2025-04-02

On-Brand Devices [Happy Health]

• 00850068747177: Happy Ring HR1401GB
• 00850068747160: Happy Ring HR1301GB
• 00850068747153: Happy Ring HR1201GB
• 00850068747146: Happy Ring HR1101GB
• 00850068747139: Happy Ring HR1001GB
• 00850068747122: Happy Ring HR0901GB
• 00850068747115: Happy Ring HR0801GB
• 00850068747108: Happy Ring HR0701GB
• 00850068747092: Happy Ring HR0601GB