Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009009512

FEI Number

3009009512

Entity Name

FUNG LEAD MEDICAL & SPORTS CO., LTD.

City/State/Country

Nantou City, TW

Establishment Address

3F, No.13, Yongxing Road, Nantou City 54067, TW

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device

Owner / Operator

Fung Lead Medical & Sports Co., Ltd. (Owner Number: 10044100)

Owner / Operator Contact Address

3F, No.13, Yongxing Road, Nantou City, TW-NAN 54067, TW

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Arm Support Corrective Shoe Orthosis Protective Suit Shoe Cast Medical Support Stocking (For General Medical Purposes) Limb Orthosis Brace Surgical Apparel Lumbar Orthosis Arm Sling Arthroscopy Holder Limb Orthosis Face Mask Isolation Gown Elastic Bandage Cervical Orthosis Filter Blue Glasses Knee Cage

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IOY	Support, Arm	Physical Medicine	Class 1	890.3475	2013-04-30
KNP	Orthosis, Corrective Shoe	Physical Medicine	Class 1	890.3475	2013-04-30
FXO	Suit, Surgical	General, Plastic Surgery	Class 1	878.4040	2020-06-04
IPG	Shoe, Cast	Physical Medicine	Class 1	890.3025	2016-02-25
FQL	Stocking, Medical Support (For General Medical Purposes)	General Hospital	Class 1	880.5780	2024-06-16
IQI	Orthosis, Limb Brace	Physical Medicine	Class 1	890.3475	2019-03-15
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	2020-04-29
IQE	Orthosis, Lumbar	Physical Medicine	Class 1	890.3490	2016-02-25
ILI	Sling, Arm	Physical Medicine	Class 1	890.3640	2013-04-30
FWZ	Operating Room Accessories Table Tray	General, Plastic Surgery	Class 1	878.4950	2015-08-07
ILH	Splint, Hand, And Components	Physical Medicine	Class 1	890.3475	2013-04-30
QKR	Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua	Unknown	Class N	N/A	2020-04-29
OEA	Non-Surgical Gown	General, Plastic Surgery	Class 1	878.4040	2020-04-29
FQM	Bandage, Elastic	General Hospital	Class 1	880.5075	2024-06-16
IQK	Orthosis, Cervical	Physical Medicine	Class 1	890.3490	2013-04-30
HOY	Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)	Ophthalmic	Class 1	886.4750	2017-08-02
ITM	Cage, Knee	Physical Medicine	Class 1	890.3475	2013-04-30

Official Correspondent

No official correspondent registered.

US Agent Details

Shu-Chen Cheng Business: ROC Chinese-European Industrial Research Society Email: ceirs.jen@msa.hinet.net Phone: (614) 5888168

Related Public Records

Same Entity

Fung Lead Medical & Sports Co., Ltd.

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-0006-2025	Ossur H F Grjothals 5 Reykjavik Iceland	1	Miami J Select Collar, Catalog: MJS-101; Miami J Select Collar Set, Catalog: MJSR-101

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1649518	Sterigenics US LLC	Fort Worth, TX, US
3007207474	BARBARAS DEVELOPMENT, INC.	Thousand Oaks, CA, US
3017619379	Jiangsu Juneng Sports Goods Technology Co., Ltd	Yangzhou Jiangsu, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009009512. Last updated year: 2026. Please use registration number 3009009512 when referencing this establishment in official correspondence.