Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3016964847

FEI Number

3016964847

Entity Name

DIRECSOURCE LIMITED

City/State/Country

HONG KONG, HK

Establishment Address

FLAT/RM A, 12/F, ZJ 300, 300 LOCKHART ROAD, WAN CHAI, HONG KONG 999077, HK

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

DIRECSOURCE LIMITED (Owner Number: 10084990)

Owner / Operator Contact Address

FLAT/RM A, 12/F, ZJ 300, 300 LOCKHART ROAD, WAN CHAI, HONG KONG, HK-NOTA 999077, HK

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Donjoy Donjoy Donjoy Procare COLLAR

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IQI	Orthosis, Limb Brace	Physical Medicine	Class 1	890.3475	2022-04-28
KYS	Insoles, Medical	General Hospital	Class 1	880.6280	2023-10-31
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	Class 2	868.1400	2022-04-28
ILI	Sling, Arm	Physical Medicine	Class 1	890.3640	2022-04-28
FMP	Protector, Skin Pressure	General Hospital	Class 1	880.6450	2022-04-28
IQE	Orthosis, Lumbar	Physical Medicine	Class 1	890.3490	2023-10-31
BYG	Mask, Oxygen	Anesthesiology	Class 1	868.5580	2022-04-28
ILZ	Accessories, Traction	Physical Medicine	Class 1	890.5925	2022-04-26
IQK	Orthosis, Cervical	Physical Medicine	Class 1	890.3490	2024-02-26
ITQ	Joint, Knee, External Brace	Physical Medicine	Class 1	890.3475	2022-04-28
ITW	Joint, Ankle, External Brace	Physical Medicine	Class 1	890.3475	2022-04-28
ILH	Splint, Hand, And Components	Physical Medicine	Class 1	890.3475	2022-04-28

Official Correspondent

Amy XU

US Agent Details

Amy XU Business: BARBARAS DEVELOPMENT, INC. Email: amyxu@bd.inc Phone: (888) 9025500

Related Public Records

Same Entity

DIRECSOURCE LIMITED

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

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K142467	Abeon Medical Corporation	IntelAir Nasal Airway Support System	2014-11-24
K861213	Datex Division Instrumentarium Corp.	PB 254 IR - SPECTROMETER	1986-04-04
K172904	Philips Medizin Systeme Boeblingen GmbH	IntelliVue Capnography Extension, IntelliVue Microstream Extension	2017-12-26

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0021-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20P (US) N, Part Number CS08651-01
Z-0024-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20 (US) N W/PRINTER, Part Number CS08657
Z-0025-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20P (US) N W/PRINTER - ROHS, Part Number CS08657-02
Z-0026-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20P (US) N W/PRINTER, Part Number CS08657-01
Z-0027-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20P (US) N W/PRINTER - ROHS, Part Number CS08657-03

Similar Registrations

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3013001618	CAST21 INC.	Evanston, IL, US
2184046	OSBORN MEDICAL CORPORATION	CENTENNIAL, CO, US
3006979871	TRULIFE, LTD.	S. Yorkshire Sheffield, GB
3006137579	ALIGNMED INC.	Irvine, CA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3016964847. Last updated year: 2026. Please use registration number 3016964847 when referencing this establishment in official correspondence.