Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010894302

FEI Number

3010894302

Entity Name

SU ZHOU HUI JIA TEXTILES CORPORATION LIMITED

City/State/Country

Su Zhou Jiangsu, CN

Establishment Address

Floor 5 Building No 5, Su Ning Industry, Park Dong Wu Nan Road, Su Zhou Jiangsu 215128, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Su Zhou Hui Jia Textiles Corporation Limited (Owner Number: 10046575)

Owner / Operator Contact Address

Floor 5 Building No 5, Su Ning Industry, Park Dong Wu Nan Road, Su Zhou, CN-JS 215128, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Back on Track calf brace Back on Track knee brace with strap Back on Track knee brace Back on Track wrist brace Back on Track elbow brace Back on Track ankle brace Back on Track back brace dual support Back on Track back brace

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	2014-04-09
IQE	Orthosis, Lumbar	Physical Medicine	Class 1	890.3490	2014-04-09

Official Correspondent

No official correspondent registered.

US Agent Details

Thomas Padula Business: Padula Consulting LLC Email: thomaspadula@schiffandcompany.com Phone: (201) 3178810

Related Public Records

Same Entity

Su Zhou Hui Jia Textiles Corporation Limited

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

View Entity Profile →

Similar Registrations

Registration Number	Establishment Name	Location
3020880065	TAYCO BRACE, INC	South Bend, IN, US
3027285106	BETTERGUARDS TECHNOLOGY GMBH	Hennigsdorf Brandenburg, DE
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 3010894302. Last updated year: 2026. Please use registration number 3010894302 when referencing this establishment in official correspondence.