Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013052700

FEI Number

3013052700

Entity Name

WELKONG SPORTS INDUSTRIAL CO.,LTD

City/State/Country

Dongguan city Guangdong, CN

Establishment Address

Room 403, Building B, 56#, Xingfu Road, Fushan Village, Liaobu Town, Dongguan city Guangdong 523428, CN

Establishment Type(s)

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

Owner / Operator

WELKONG SPORTS INDUSTRIAL CO.,LTD (Owner Number: 10056498)

Owner / Operator Contact Address

Room 403, Building B, 56#, Xingfu Road, Fushan Village, Liaobu Town, Dongguan city, CN-GD 523000, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

mattress (medical purpose), comforter weighted blanket, weighted comforter, weighted sleeping bag, sleeping bag, bedding, pad, sheet, mattress cover, mattress (medical purpose), comforter weighted blanket, weighted comforter, weighted sleeping bag, sleeping bag, bedding, pad, sheet, mattress cover, weighted blanket, weighted comforter, weighted sleeping bag, sleeping bag, bedding, pad, sheet, mattress cover, mattress (medical purpose), comforter, Bed rail bumper Wrist Braces & Supports, Back Support Braces Cervical collar/ Philadelphia collar Hand Support & Thumb Stabilizer Braces, Elbow Braces & Supports Cam walker, ankle walker, knee walker splint, Ankle Braces & Supports Pump belt mattress (medical purpose), comforter weighted blanket, weighted comforter, weighted sleeping bag, sleeping bag, bedding, pad, sheet, mattress cover, Heated eye mask Red Light Therapy Belt, Red Light Therapy Mask, Red Light Therapy Eye Mask, Red Light Therapy Knee, Red Light Therapy Device, Near Infrared Light Therapy Device, Red Light Therapy Mat, Red Light Therapy Belt, Red Light Therapy for Neck, Red Light Therapy for Body, Red Light Therapy for Face, LED Face Mask Light Therapy, Knee Braces & Sleeves, Shoulder Braces & Support, Dog Knee Brace/Ankle Brace/Leg Brace PACK, HOT OR COLD, REUSABLE Foot Support & Compression Socks

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LYG	Massager, Therapeutic, Manual	Physical Medicine	Class 1	890.5660	2024-06-26
KNM	Device, Pressure Applying	Physical Medicine	Class 1	890.5765	2024-06-26
KME	Bedding, Disposable, Medical	General Hospital	Class 1	880.6060	2024-06-26
ISR	Band Or Belt, Pelvic Support	Physical Medicine	Class 1	890.3025	2017-12-14
IQK	Orthosis, Cervical	Physical Medicine	Class 1	890.3490	2017-12-14
IQI	Orthosis, Limb Brace	Physical Medicine	Class 1	890.3475	2017-12-14
ITW	Joint, Ankle, External Brace	Physical Medicine	Class 1	890.3475	2017-12-14
FQM	Bandage, Elastic	General Hospital	Class 1	880.5075	2024-03-25
FMW	Cover, Mattress (Medical Purposes)	General Hospital	Class 1	880.6190	2024-06-26
ILY	Lamp, Infrared, Therapeutic Heating	Physical Medicine	Class 2	890.5500	2026-04-08
ITQ	Joint, Knee, External Brace	Physical Medicine	Class 1	890.3475	2017-12-14
IME	Pack, Hot Or Cold, Reusable	Physical Medicine	Class 1	890.5700	2018-12-28
FQL	Stocking, Medical Support (For General Medical Purposes)	General Hospital	Class 1	880.5780	2017-12-14

Official Correspondent

Sam Zhang

US Agent Details

Leeyeo Kee Business: Regrek LLC Email: regrek.cs@hotmail.com Phone: (302) 6089028

Related Public Records

Same Entity

WELKONG SPORTS INDUSTRIAL 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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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013052700. Last updated year: 2026. Please use registration number 3013052700 when referencing this establishment in official correspondence.