Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013527364

FEI Number

3013527364

Entity Name

HENGSHUI XUKANG MEDICAL APPLIANCES CO., LTD.

City/State/Country

Hengshui City Hebei, CN

Establishment Address

Xinzheng Village, Anping County, Hengshui City Hebei 053605, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Hengshui Xukang Medical Appliances Co., Ltd. (Owner Number: 10053418)

Owner / Operator Contact Address

Xinzheng Village, Anping County, Hebei Province, Hengshui City, CN-HE 053605, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Posture Corrector, Neck brace, Back Support, Body Pillow, Rib fixation band Bedsore Pad Orthosis, Limb Fixed Belt, Knee Elbow Orthosis, Medical Fixed Belt, Pregnant Support Belt Plantar Fasciitis Night Splint Tourniquet Canes Bunion corrector, Foot Arch Support, Ankle Brace-ASTN Crutches Bandages Leg Calf Stretcher Kneepad, Ankle Support, Elbow Support, Shoulder Support, Wrist Support Knee support, Knee Brace-ASTN, Arthritis Gloves Arm sling; Arm Sling with Pillow Bunion corrector,Foot Arch Support Walker Boot Elastic Stretch Net Cap

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MRI	Orthosis, Truncal/Orthosis, Limb	Physical Medicine	Class 1	890.3490	2016-12-03
FNM	Mattress, Air Flotation, Alternating Pressure	General Hospital	Class 2	880.5550	2016-12-03
IQE	Orthosis, Lumbar	Physical Medicine	Class 1	890.3490	2016-12-03
FZF	Splint, Extremity, Inflatable, External	General, Plastic Surgery	Class 1	878.3900	2021-12-30
GAX	Tourniquet, Nonpneumatic	General, Plastic Surgery	Class 1	878.5900	2016-12-03
IPS	Cane	Physical Medicine	Class 1	890.3075	2016-12-03
ITW	Joint, Ankle, External Brace	Physical Medicine	Class 1	890.3475	2019-10-25
IPR	Crutch	Physical Medicine	Class 1	890.3150	2016-12-03
FQM	Bandage, Elastic	General Hospital	Class 1	880.5075	2016-12-03
NZD	Stretcher, Patient Restraint	General Hospital	Class 1	880.6900	2021-12-30
ITQ	Joint, Knee, External Brace	Physical Medicine	Class 1	890.3475	2016-12-03
ILI	Sling, Arm	Physical Medicine	Class 1	890.3640	2017-11-08
ITW	Joint, Ankle, External Brace	Physical Medicine	Class 1	890.3475	2019-10-25
KNP	Orthosis, Corrective Shoe	Physical Medicine	Class 1	890.3475	2016-12-03
FYF	Cap, Surgical	General, Plastic Surgery	Class 1	878.4040	2016-12-03

Official Correspondent

Jiacheng Li

US Agent Details

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

Related Public Records

Same Entity

Hengshui Xukang Medical Appliances 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 3013527364. Last updated year: 2026. Please use registration number 3013527364 when referencing this establishment in official correspondence.