Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013019743

FEI Number

3013019743

Entity Name

SOBERLINK HEALTHCARE LLC

City/State/Country

Huntington Beach, CA, US

Establishment Address

7711 Center Avenue, #400, Huntington Beach, CA 92647, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device,Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Soberlink Healthcare LLC (Owner Number: 10052354)

Owner / Operator Contact Address

7711 Center Avenue, #400, Huntington Beach, CA 92647, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K160613

PMA Number

N/A

All Registered Proprietary Names

Soberlink Cellular Device and Sober Sky Web Portal

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DJZ	Devices, Breath Trapping, Alcohol	Clinical Toxicology	Class 1	862.3050	2016-07-19

Official Correspondent

Brad Keays

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Soberlink Healthcare LLC

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Similar Registrations

Registration Number	Establishment Name	Location
3002956991	PAS SYSTEMS INTERNATIONAL INC	Durham, NC, US
3007343307	DA TECH CO LTD	Incheon, KR
3042276415	SHENZHEN MEIRUI SHANGPIN TECHNOLOGY CO., LTD.	Shenzhen Guangdong, CN
3013585270	Consumer Safety Technology, LLC	Urbandale, IA, US
2030633	JANT PHARMACAL CORP.	ENCINO, CA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013019743. Last updated year: 2026. Please use registration number 3013019743 when referencing this establishment in official correspondence.