Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3021275665

FEI Number

3021275665

Entity Name

Hubei Dacheng Medical Technology Co., LTD.

City/State/Country

XianNing City Hubei, CN

Establishment Address

NanLin ShuangChuan Industrial Park, NanLinQiao Town TongShan Conty, XianNing City Hubei 437600, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Dongguan KIO Electronic Materials Co., Ltd (Owner Number: 10052782)

Owner / Operator Contact Address

The 3rd Industrial District,DiChong,, GaoBu Town,, DongGuan,, CN-GD 523273, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

DARCO CLAVICLE SPLINT SQUARE TOE MEDICAL SHOE ORTHOWEDGE ALL PURPOSE BOOT DUO SHOE SQUARE TOE APB CLASSIC POST OP WRIST BRACE BLACK FOAM WRIST BRACE Body Armor Sport PNEUMATIC NIGHT SPLINT AIR TRAVELER WALKER BODY ARMOR STIRRUP WALKER PNEUMATIC BODY ARMOR PRO TERM MULTI PHASE PAD Promotion Insole DUAL ADJUSTABLE BACK SUPPORT Donjoy MONOFILAMENT FOOT SCREEN TEST SINGLE USE MONOFILAMENT MFT McKesson MFT Cast Shoe Body Armor Cast Shoe Slimline Cast Boot

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IQJ	Splint, Clavicle	Physical Medicine	Class 1	890.3490	2021-11-12
KNP	Orthosis, Corrective Shoe	Physical Medicine	Class 1	890.3475	2016-10-05
ILH	Splint, Hand, And Components	Physical Medicine	Class 1	890.3475	2018-06-07
ITW	Joint, Ankle, External Brace	Physical Medicine	Class 1	890.3475	2019-08-26
FZF	Splint, Extremity, Inflatable, External	General, Plastic Surgery	Class 1	878.3900	2018-02-09
FMP	Protector, Skin Pressure	General Hospital	Class 1	880.6450	2018-02-09
IPY	Orthosis, Lumbo-Sacral	Physical Medicine	Class 1	890.3490	2019-02-06
KYS	Insoles, Medical	General Hospital	Class 1	880.6280	2023-08-02
GXB	Esthesiometer	Neurology	Class 1	882.1500	2017-04-21
IPG	Shoe, Cast	Physical Medicine	Class 1	890.3025	2017-09-12

Official Correspondent

No official correspondent registered.

US Agent Details

Mark Cooper Business: DARCO International, Inc. Email: mcooper@darcointernational.com Phone: (304) 5224883

Related Public Records

Same Entity

Dongguan KIO Electronic Materials Co., Ltd

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3021275665. Last updated year: 2026. Please use registration number 3021275665 when referencing this establishment in official correspondence.