Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009879967

FEI Number

3009879967

Entity Name

ONYX HEALTHCARE INC.

City/State/Country

NEW TAIPEI CITY, TW

Establishment Address

4F., No. 135, Ln. 235, Baoqiao Rd.,, Xindian Dist., NEW TAIPEI CITY 231, TW

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

ONYX Healthcare Inc. (Owner Number: 10044484)

Owner / Operator Contact Address

4F, No. 135, Lane 235, Pao Chiao Rd., Xindian Dist., New Taipei City, TW-NWT 231, TW

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ILQ	System, Communication, Powered	Physical Medicine	Class 2	890.3710	2013-06-18

Official Correspondent

Brian Wang

US Agent Details

Jeff Liu Business: Onyx Healthcare USA, Inc. Email: Jeffliu@onyx-healthcare.com Phone: (714) 7920774

Related Public Records

Same Entity

ONYX Healthcare Inc.

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

View Entity Profile →

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0004-2016	Lifeline Systems, Incorporated	2	Philips GoSafe Mobile Help Button; 7000MHB. Personal Emergency Response System.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009879967. Last updated year: 2026. Please use registration number 3009879967 when referencing this establishment in official correspondence.