Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013522894

FEI Number

3013522894

Entity Name

YANGZHOU FEIYALI SPORTING GOODS CO.LTD

City/State/Country

Yangzhou Jiangsu, CN

Establishment Address

Fanchuan Science and Technology Park,, Jiangdu District,, Yangzhou Jiangsu 225200, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer),Manufacture Medical Device

Owner / Operator

Yangzhou Feiyali Sporting Goods CO.Ltd (Owner Number: 10054611)

Owner / Operator Contact Address

Fanchuan Science and Technology Park,, Jiangdu District,, Yangzhou, CN-JS 225200, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

cycling gloves Orthosis, Lumbo-Sacral Splint, Hand, And Components WRIST AND PALM SUPPORT Orthosis, Truncal/Orthosis, Limb Posture Trainer KINESIOLOGY TAPE RESISTANCE BANDS Orthosis, Abdominal Orthosis, Cervical Orthosis, Limb Brace Sling, Arm

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IWP	Radiographic Protective Glove	Radiology	Class 1	892.6500	2021-02-04
IPY	Orthosis, Lumbo-Sacral	Physical Medicine	Class 1	890.3490	2017-04-06
ILH	Splint, Hand, And Components	Physical Medicine	Class 1	890.3475	2017-04-06
MRI	Orthosis, Truncal/Orthosis, Limb	Physical Medicine	Class 1	890.3490	2017-04-06
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2021-04-21
KTD	Orthosis, Abdominal	Physical Medicine	Class 1	890.3490	2017-04-06
IQK	Orthosis, Cervical	Physical Medicine	Class 1	890.3490	2017-04-06
ITQ	Joint, Knee, External Brace	Physical Medicine	Class 1	890.3475	2017-04-06
IQI	Orthosis, Limb Brace	Physical Medicine	Class 1	890.3475	2017-04-06
IQE	Orthosis, Lumbar	Physical Medicine	Class 1	890.3490	2019-12-11
ILI	Sling, Arm	Physical Medicine	Class 1	890.3640	2017-04-06

Official Correspondent

Keven He

US Agent Details

Leeyeo Kee Business: Regrek LLC Email: regrek.cs@hotmail.com Phone: (303) 3026089

Related Public Records

Same Entity

Yangzhou Feiyali Sporting Goods CO.Ltd

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
K843874	Beiersdorf, Inc.	LEUKOPOR SURGICAL TAPE	1985-02-21
K915446	Sun Glitz Corp.	STRETCH WRAP	1992-05-06
K833120	Acme United Corp.	ONE TIME COMPOUND BENZOIN TINCTURE-	1983-12-29
K870091	Avery Intl.	IV SECUREMENT DEVICE USING PCCE THERMO. FILM	1987-02-04

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

Similar Registrations

Registration Number	Establishment Name	Location
3014437893	NINGBO CHIBANDA IMP &EXP CO, LTD	Ningbo Zhejiang, CN
8043736	ANSELL N.P. SDN. BHD.	MELAKA, MY
2124215	Boston Scientific Corporation	Saint Paul, MN, US
3015378469	PUJIANG JIANYU SANITARY PRODUCTS COMPANY LTD.	Jinhua Zhejiang, CN
3012309743	Yiwu Ori-Power Medtech Co., Ltd.	YIWU Zhejiang, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013522894. Last updated year: 2026. Please use registration number 3013522894 when referencing this establishment in official correspondence.