Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013657868

FEI Number

3013657868

Entity Name

DONGGUAN SUPERCARE MEDICAL PRODUCTS CO., LTD

City/State/Country

Dongguan Guangdong, CN

Establishment Address

NO. 22 QULING 2ND ROAD, QUANTANG, LIAOBU TOWN, Dongguan Guangdong 523418, CN

Establishment Type(s)

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

Owner / Operator

DONGGUAN SUPERCARE MEDICAL PRODUCTS CO., LTD (Owner Number: 10056657)

Owner / Operator Contact Address

NO. 22 QULING 2ND ROAD, QUANTANG, LIAOBU TOWN, Dongguan, CN-GD 523418, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Silicone insole, Silicone Heel Cup CAM WALKER ,CRUTCH ORTHOSIS, CERVICAL-THORACIC, RIGID TAPE AND BANDAGE, ADHESIVE ORTHOSIS, LUMBO- SACRAL Orthosis Limb Brace CERVICAL COLLARS Knee support HEAD HALTER ORTHOSIS, RIB FRACTURE,Rib Belt THIGH SUPPORT CALF SUPPORT calf extender ATHLETIC TAPE FINGER SPLINTS ORTHOSIS,CORRECTIVE SHOE ABDOMINAL BINDER FUNCTIONAL KNEE BRACE ANKLE BRACE,JOINT,ANKLE,EXTERANL BRACE HIP ABDUCTION KIT BACK SUPPORT HERINA BELT ELBOW SUPPORTS Orthosis, Foot Drop Orthosis, lumbar, complete panel disposable mask, face mask Joint, Knee, External Limb Component ABDOMINAL SUPPORTS Orthosis Limb Orthosis Truncal Unit, Wrist, External Limb Component, Mechanical ORTHOSIS, SACROILIAC, SOFT WRIST BRACE, HAND SUPPORT BAG, ICE disposable mask, face mask

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KYS	Insoles, Medical	General Hospital	Class 1	880.6280	2020-06-17
IPR	Crutch	Physical Medicine	Class 1	890.3150	2017-12-30
IQF	Orthosis, Cervical-Thoracic, Rigid	Physical Medicine	Class 1	890.3490	2020-06-16
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2020-06-16
IPY	Orthosis, Lumbo-Sacral	Physical Medicine	Class 1	890.3490	2017-12-30
IQI	Orthosis, Limb Brace	Physical Medicine	Class 1	890.3475	2020-06-06
IQK	Orthosis, Cervical	Physical Medicine	Class 1	890.3490	2017-12-30
ITQ	Joint, Knee, External Brace	Physical Medicine	Class 1	890.3475	2017-12-30
IPX	Orthosis, Rib Fracture, Soft	Physical Medicine	Class 1	890.3490	2020-06-16
ILG	Stocking, Elastic	Physical Medicine	Class 1	890.3475	2017-12-30
FQM	Bandage, Elastic	General Hospital	Class 1	880.5075	2020-06-16
NOC	Splint, Extremity, Non-Inflatable, External, Non-Sterile	General, Plastic Surgery	Class 1	878.3910	2017-12-30
KNP	Orthosis, Corrective Shoe	Physical Medicine	Class 1	890.3475	2017-12-30
FSD	Binder, Abdominal	General Hospital	Class 1	880.5160	2017-12-30
ITM	Cage, Knee	Physical Medicine	Class 1	890.3475	2020-06-16
ITW	Joint, Ankle, External Brace	Physical Medicine	Class 1	890.3475	2017-12-30
ITS	Joint, Hip, External Brace	Physical Medicine	Class 1	890.3475	2020-06-13
IOZ	Splint, Abduction, Congenital Hip Dislocation	Physical Medicine	Class 1	890.3665	2020-06-16
ISR	Band Or Belt, Pelvic Support	Physical Medicine	Class 1	890.3025	2017-12-30
EXN	Support, Hernia	Gastroenterology, Urology	Class 1	876.5970	2017-12-30
IOY	Support, Arm	Physical Medicine	Class 1	890.3475	2018-01-10
OHI	Orthosis, Foot Drop	Physical Medicine	Class 1	890.3475	2020-06-17
IQE	Orthosis, Lumbar	Physical Medicine	Class 1	890.3490	2019-05-20
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	2020-03-30
ISY	Joint, Knee, External Limb Component	Physical Medicine	Class 1	890.3420	2022-11-21
KTD	Orthosis, Abdominal	Physical Medicine	Class 1	890.3490	2020-06-16
MRI	Orthosis, Truncal/Orthosis, Limb	Physical Medicine	Class 1	890.3490	2020-06-06
ISZ	Unit, Wrist, External Limb Component, Mechanical	Physical Medicine	Class 1	890.3420	2020-06-17
IPW	Orthosis, Sacroiliac, Soft	Physical Medicine	Class 1	890.3490	2020-06-17
ILH	Splint, Hand, And Components	Physical Medicine	Class 1	890.3475	2018-01-10
KYR	Bag, Ice	General Hospital	Class 1	880.6050	2017-12-30
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	2020-03-30

Official Correspondent

ROCK WANG

US Agent Details

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

Related Public Records

Same Entity

DONGGUAN SUPERCARE MEDICAL PRODUCTS 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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013657868. Last updated year: 2026. Please use registration number 3013657868 when referencing this establishment in official correspondence.