BIG HEALTH INC

FDA Device Registration & Listing · Newport Beach, CA, US · Registration 3024442350

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
3024442350
FEI Number
3024442350
Entity Name
BIG HEALTH INC
City/State/Country
Newport Beach, CA, US
Establishment Address
2067 Port Bristol Cir, Newport Beach, CA 92660, US
Establishment Type(s)
Manufacture Medical Device,Complaint File Establishment per 21 CFR 820.198
Owner / Operator
Big Health (Owner Number: 10088537)
Owner / Operator Contact Address
2067 Port Bristol Cir, Newport Beach, CA 92660, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K233872
PMA Number
N/A

All Registered Proprietary Names

SleepioRx DaylightRx

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
QVO Computerized Behavioral Therapy Device For Insomnia Neurology Class 2 882.5801 2025-01-02
SCP Computerized Behavioral Therapy Device For Anxiety Disorders Neurology Class 2 882.5801 2025-01-02

Official Correspondent

Reuben Lawson

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

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

Similar Registrations

Registration Number Establishment Name Location
3007389703 NOX MEDICAL Reykjavik, IS
3028606342 OMAY(GUANGZHOU) MED TECHNOLOGIES CO., LTD Guangzhou Guangdong, CN
3038274470 BRAINMATTERZ, INC McKinney, TX, US
3012404174 LABORATORIO CHIMICO FARMACEUTICO A. SELLA SRL. Schio Vicenza, IT
3042364673 NEURALYTIX LLC Fruita, CO, US
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3024442350. Last updated year: 2026. Please use registration number 3024442350 when referencing this establishment in official correspondence.
Legal Disclaimer: AvaSpecs is not affiliated with the FDA or any government agency and does not provide medical, legal, regulatory, safety, approval, clearance, effectiveness, endorsement, or compliance advice. This index page is built using public record archives and does not represent an official regulatory determination.
Account Required Full available specs will require a free AvaSpecs account.