Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3012281713

FEI Number

3012281713

Entity Name

FENGLIN INDUSTRY CO., LTD.

City/State/Country

Dongguan City Guangdong, CN

Establishment Address

1st Industry Zone, Tanxi West Road, Shipai Town, Dongguan City Guangdong 523330, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Fenglin Industry Co., Ltd. (Owner Number: 10050432)

Owner / Operator Contact Address

1st Industry Zone, Tanxi West Road, Shipai Town, Dongguan City, CN-GD 523330, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Square Toe, Mesh Top, Post-Op Shoe Disposable Medical Mask Disposable Epidemic Prevention Mask DA-K2B99 DA-K2B95 Cast Shoe

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	2019-02-28
KNP	Orthosis, Corrective Shoe	Physical Medicine	Class 1	890.3475	2015-11-17
FWZ	Operating Room Accessories Table Tray	General, Plastic Surgery	Class 1	878.4950	2019-02-28
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	2020-04-14
IQE	Orthosis, Lumbar	Physical Medicine	Class 1	890.3490	2019-02-28
ILH	Splint, Hand, And Components	Physical Medicine	Class 1	890.3475	2019-02-28
ITQ	Joint, Knee, External Brace	Physical Medicine	Class 1	890.3475	2019-02-28
IPG	Shoe, Cast	Physical Medicine	Class 1	890.3025	2022-11-29

Official Correspondent

No official correspondent registered.

US Agent Details

David Lennarz Business: Registrar Corp Email: david.lennarz@registrarcorp.com Phone: (757) 2240177

Related Public Records

Same Entity

Fenglin Industry Co., Ltd.

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

View Entity Profile →

Similar Registrations

Registration Number	Establishment Name	Location
3005088750	3M POLAND MANUFACTURING SP. Z O.O	WROCLAW Dolnoslaskie, PL
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 3012281713. Last updated year: 2026. Please use registration number 3012281713 when referencing this establishment in official correspondence.