Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005841961

FEI Number

3005841961

Entity Name

BEIJING JINWEI KANGDA MEDICAL INSTRUMENT LTD.

City/State/Country

Langfang City Hebei, CN

Establishment Address

Industrial Park, Guan County, Langfang City Hebei 065500, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Beijing Jinwei Kangda Medical Instrument Ltd. (Owner Number: 10029562)

Owner / Operator Contact Address

Room 1406-1409,1st Building, No. 14 Courtyard, South Road of Western 3rd Ring-Road, Fengtai District, Beijing, CN-NOTA 100073, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Fifth Metacarpal Bone Brace Palm Protector (Knitted) First Metacarpal Brace Middle Metacarpal Brace Hinged Wrist Support Palm Protector (Sport) Wrist Protector (Sport) Distal Metacarpal Brace Light Wrist Support (Palm wrist brace) Proximal Metacarpal Bone Brace Wrist Protector (Knitted) Infusion Splint Short Thumb Spica Long Thumb Spica Thumb Brace Finger Splint Hand Finger Splint Adjustable (Palm)Wrist Brace Shoulder Abduction Brace Rom Shoulder Brace Hallux Valgus Brace Knee Ankle Foot Orthosis Shoulder Support Hip Protector Adult Hinged Hip Abduction Orthosis Brace Pediatric Hinged Hip Abduction Brace Sleeve Cast Roll Splint Soft Cast Waterless Cast Medical Splint ( 312, 335,415, 420, 430, 520, 530, 545, 630, 645) Medical Casting Tape / CAST TAPE, BANDAGE ( 2 3 4 5 6) Ankle Brace With Air Bag Walker Boots Adjustable Knee Brace OA Knee Brace Medical Stockinette Medical Cast Padding Night Splint Elastic Bandage Isolation Gown, Cover Gown, Protective Gown Waist Protector (Sport) Lumbar Extender Lumbar Support Lumbar Brace Lumbar Protector Waist Protector (Knitted) Medical Elastic Lumbostad Corset Lumbar Brace (Drawstring) Cervical Collar Emergency Neck Collar Adjustable Cervical Collar Medical Face Shield Denis Splint Ankle Brace Ankle Protector (Sport) Adjustable Ankle Foot Brace Ankle Protector (Knitted) Foot Splint Laced Ankle Brace Posture Corrector Back Posture Orthosis Safety Goggles Medical Goggles Goggles Protective Glasses Nursing Goggles

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ILH	Splint, Hand, And Components	Physical Medicine	Class 1	890.3475	2016-02-16
IQI	Orthosis, Limb Brace	Physical Medicine	Class 1	890.3475	2016-02-16
ITS	Joint, Hip, External Brace	Physical Medicine	Class 1	890.3475	2016-02-16
ITG	Bandage, Cast	Physical Medicine	Class 1	890.3025	2009-05-30
FZF	Splint, Extremity, Inflatable, External	General, Plastic Surgery	Class 1	878.3900	2020-04-21
ITM	Cage, Knee	Physical Medicine	Class 1	890.3475	2016-02-16
IPM	Cover, Limb	Physical Medicine	Class 1	890.3025	2016-12-06
NOC	Splint, Extremity, Non-Inflatable, External, Non-Sterile	General, Plastic Surgery	Class 1	878.3910	2020-04-21
FQM	Bandage, Elastic	General Hospital	Class 1	880.5075	2016-12-06
OEA	Non-Surgical Gown	General, Plastic Surgery	Class 1	878.4040	2020-04-21
IQE	Orthosis, Lumbar	Physical Medicine	Class 1	890.3490	2016-02-16
IQK	Orthosis, Cervical	Physical Medicine	Class 1	890.3490	2016-02-16
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	2020-04-21
ITN	Splint, Denis Brown	Physical Medicine	Class 1	890.3675	2016-02-16
ITW	Joint, Ankle, External Brace	Physical Medicine	Class 1	890.3475	2016-02-16
MRI	Orthosis, Truncal/Orthosis, Limb	Physical Medicine	Class 1	890.3490	2020-04-21
HOY	Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)	Ophthalmic	Class 1	886.4750	2020-04-21

Official Correspondent

No official correspondent registered.

US Agent Details

Charles Mack Business: IRC USA Email: ircfda@gmail.com Phone: (931) 6254938

Related Public Records

Same Entity

Beijing Jinwei Kangda Medical Instrument 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 3005841961. Last updated year: 2026. Please use registration number 3005841961 when referencing this establishment in official correspondence.