Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007942528

FEI Number

3007942528

Entity Name

WELLPOWER SPORTING GOODS CO., LTD.

City/State/Country

Dong Guan Guangdong, CN

Establishment Address

No.62 Liaobu Xinglong Street,, Liaobu Town, Dong Guan Guangdong 523425, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

WELLPOWER SPORTING GOODS CO., LTD. (Owner Number: 10030640)

Owner / Operator Contact Address

#112, YaoLe Section, LiaoFu Road, LiaoBu Town, Dong Guan, CN-GD 523425, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Phyziofit Medical Surgical Mask Knee Support with Cross Strap; Ligament Knee Support; Multipurpose Knee Support; Adjustable Knee Support; Breathable Open Patella Knee Support; Elastic Brace-Knee; Knee Sling; Permium Knee Brace OA Knee Brace; Open Fixed Support of Knee; Open Fixed Support of Knee-Sandwich Mesh; Original POST-OP; Coverall; Non-surgical isolation gown; Non-surgical protective clothing Stocking, medical support (to prevent pooling of blood in legs) Cervical Collar; Cervical Stablizer; Cervical Strap; Universal Collar Hip Abduction Orthosis Disposable medical mask; Disposable protective mask; Face Mask Disposable face mask; Disposable medical mask; Disposable protective mask Arm Sling; Arm Sling with Thumb Loop; Compression Elbow Sleeve with Gel Cap DA161ES01 series Elastic Elbow; DA161ES02 series Deluxe Elastic Elbow; DA161GL01 series Arthritis Gloves; DA161KS01 series Elastic Knee; DA161KS02 series Deluxe Elastic Knee; DA161AV01 series Elastic Ankle; DA161AV02 series Deluxe Elastic Ankle; DA161AV03 series Figure 8 Ankle Support DA161WB01 series Stabilizing Elastic Wrist with Palmar Stay; DRESSING, COMPRESSION Adjustable Elbow Support; Adjustable Shoulder Support; Adjustable Shoulder Support with Elastic Strap; Adjustable Tennis Adjustable wrist support; Arthritis Gloves; Elastic Brace-Elbow; Elbow Support; Permium Elbow Brace; POST-OP Elbow; Tennis Elbow Strap; Upper Limb Brace; Wrist Brace with BOA Finger Splint; FOID over Finger COT; SPLINT WRIST SUPPORT, Style 773000; Thermal Thumb Spica; Thermal Thumb Support; Wrist splint

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FXX	Mask, Surgical	General, Plastic Surgery	Class 2	878.4040	2021-04-07
ITQ	Joint, Knee, External Brace	Physical Medicine	Class 1	890.3475	2018-12-14
OEA	Non-Surgical Gown	General, Plastic Surgery	Class 1	878.4040	2020-03-31
DWL	Stocking, Medical Support (To Prevent Pooling Of Blood In Legs)	General Hospital	Class 2	880.5780	2016-08-26
IQK	Orthosis, Cervical	Physical Medicine	Class 1	890.3490	2018-12-14
ITS	Joint, Hip, External Brace	Physical Medicine	Class 1	890.3475	2018-12-14
MSH	Respirator, Surgical	General, Plastic Surgery	Class 2	878.4040	2020-03-23
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	2020-04-05
ILE	Sling, Arm, Overhead Supported	Physical Medicine	Class 1	890.3475	2018-12-14
MHW	Dressing, Compression	General Hospital	Class 1	880.5075	2009-10-26
IQI	Orthosis, Limb Brace	Physical Medicine	Class 1	890.3475	2012-10-24
ILH	Splint, Hand, And Components	Physical Medicine	Class 1	890.3475	2017-07-10

Official Correspondent

Tom Xiong

US Agent Details

Josh Field Email: josh@wellpowerusa.com Phone: (781) 5932697

Related Public Records

Same Entity

WELLPOWER 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
K201622	Guangdong Kingfa Sci. & Tech.Co., Ltd.	Medical surgical mask	2020-11-24
K881618	3M Company	ASEPTEX 1809 FLUID-RESISTANT MOLDED SURGICAL MASK	1988-05-09
K102092	Prestige Ameritech	PRO GEAR N95 PARTICULATE FILTER RESPIRATOR & SURGICAL MASK, REGULAR SIZE MODEL RP CERIES	2010-10-06

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
3016247944	HYGENIX HEALTH SOLUTIONS LLC	Torrance, CA, US
3016765490	XIAMEN CHUANFUTANG PHARMACEUTICAL CO.,LTD	xiamen Fujian, CN
3018382937	MID-AMERICA SAFETY CORP	Elk Grove Village, IL, US
3017598017	DURIO PPE SDN. BHD.	Johor Bahru, MY
3002813051	IRIS USA INC	Pleasant Prairie, WI, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007942528. Last updated year: 2026. Please use registration number 3007942528 when referencing this establishment in official correspondence.