Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009657307

FEI Number

3009657307

Entity Name

ANPING HUAKANG MEDICAL PRODUCTS FACTORY

City/State/Country

Hengshui Hebei, CN

Establishment Address

NO.88, XINZHENG DEVELOPMENT ZONE, Anping, Hengshui Hebei 053600, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Anping Huakang Medical Products Factory (Owner Number: 10051349)

Owner / Operator Contact Address

NO.88, XINZHENG DEVELOPMENT ZONE, Anping, Hengshui, CN-HE 053600, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Foot Support Body support Waist Support SPLINT,HAND,AND COMPONENTS Knee support Leg support Neck support Air cushion Multiple Sizes of Steam Packs

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ITW	Joint, Ankle, External Brace	Physical Medicine	Class 1	890.3475	2016-03-04
MRI	Orthosis, Truncal/Orthosis, Limb	Physical Medicine	Class 1	890.3490	2018-12-13
IQE	Orthosis, Lumbar	Physical Medicine	Class 1	890.3490	2016-03-04
ILH	Splint, Hand, And Components	Physical Medicine	Class 1	890.3475	2020-11-26
ITQ	Joint, Knee, External Brace	Physical Medicine	Class 1	890.3475	2016-03-04
IQK	Orthosis, Cervical	Physical Medicine	Class 1	890.3490	2016-03-04
KIC	Cushion, Flotation	Physical Medicine	Class 1	890.3175	2017-12-30
IMA	Pack, Heat, Moist	Physical Medicine	Class 1	890.5730	2022-11-27

Official Correspondent

William Yan

US Agent Details

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

Related Public Records

Same Entity

Anping Huakang Medical Products Factory

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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3043364423	SAMGEN MEDICAL LLC	Cherry Hill, NJ, US
3010646683	HARNOSANDS PLASTINDUSTRI AB	Harnosand Vasternorrland, SE
3012164853	Wilsons nc Enterprice LLC	Washington, NC, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009657307. Last updated year: 2026. Please use registration number 3009657307 when referencing this establishment in official correspondence.