Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010309201

FEI Number

3010309201

Entity Name

Fengtai County Guqiao Town Changxing Shoe Factory

City/State/Country

Huainan City Anhui, CN

Establishment Address

100 Meters West of Guqiao Primary School, Guqiao Village, Guqiao Town, Fengtai County, Huainan City Anhui 23200, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Position Health, LLC (Owner Number: 10059354)

Owner / Operator Contact Address

736 North Western Avenue, Suite 314, Lake Forest, IL 60045, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Cast Wedge Gaitkeeper Heel/Elbow Protector, Knee Separator, Ulnar Nerve Protector HEELIFT (Suspension Boot), HEELIFT Glide, HEELIFT Classic, HEELIFT Traction, HEELIFT AFO, HEELIFT Anti Rotation Wedge ELBOWLIFT Suspension Pad TurnAssist Premium Patient Repositioning System Wedges (30 degree body support wedge) AnkleTough Position Health Classic Post-Op Shoe TurnAssist Premium Patient Repositioning System Turning Sheet

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LGF	Component, Cast	Orthopedic	Class 1	888.5940	2018-12-26
IPG	Shoe, Cast	Physical Medicine	Class 1	890.3025	2018-12-26
FMP	Protector, Skin Pressure	General Hospital	Class 1	880.6450	2018-12-26
IOD	Components, Exercise	Physical Medicine	Class 1	890.5350	2018-12-26
KNP	Orthosis, Corrective Shoe	Physical Medicine	Class 1	890.3475	2023-09-18
FMR	Device, Transfer, Patient, Manual	General Hospital	Class 1	880.6785	2019-06-07

Official Correspondent

No official correspondent registered.

US Agent Details

Charles Walgreen Email: charles@positionhealthusa.com Phone: (847) 3289540

Related Public Records

Same Entity

Position Health, LLC

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
1424774	Position Health, LLC	Lake Forest, IL, US

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010309201. Last updated year: 2026. Please use registration number 3010309201 when referencing this establishment in official correspondence.