Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011497619

FEI Number

3011497619

Entity Name

Dongguan Vigor Textile Co.,Ltd

City/State/Country

Dongguan Guangdong, CN

Establishment Address

The 5th Floor, Building 2, Baili Industrial Park, No.382 Liaodong Road, Xixi Village, Liaobu Town, Dongguan Guangdong 523427, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer),Manufacture Medical Device

Owner / Operator

Dongguan Vigor Textile Co.,Ltd (Owner Number: 10048018)

Owner / Operator Contact Address

The 5th Floor, Building 2, Baili Industrial Park, No.386 Liaodong Road, Xixi Village, Liaobu Town, Dongguan, CN-GD 523427, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ILI	Sling, Arm	Physical Medicine	Class 1	890.3640	2014-11-25
HSP	Splint, Traction	Orthopedic	Class 1	888.5890	2014-11-25
INE	Sling, Overhead Suspension, Wheelchair	Physical Medicine	Class 1	890.3910	2014-12-10
ILH	Splint, Hand, And Components	Physical Medicine	Class 1	890.3475	2014-11-25
NOC	Splint, Extremity, Non-Inflatable, External, Non-Sterile	General, Plastic Surgery	Class 1	878.3910	2014-11-25
IOZ	Splint, Abduction, Congenital Hip Dislocation	Physical Medicine	Class 1	890.3665	2014-11-25
ITN	Splint, Denis Brown	Physical Medicine	Class 1	890.3675	2014-11-25
FSA	Lift, Patient, Non-Ac-Powered	General Hospital	Class 1	880.5510	2014-12-10

Official Correspondent

Daniel Jensen

US Agent Details

FANFEI LIU Email: U.S.agent@frosatechnology.com Phone: (626) 8261385

Related Public Records

Same Entity

Dongguan Vigor Textile Co.,Ltd

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-0013-2018	Handicare Usa Inc	1	PRISM MEDICAL A-625, MAX. LOAD 625 lbs. 283 Kgs., Patient lift, non-A/C powered
Z-0014-2018	Handicare AB Maskinvagen	1	Carina Mobile Lifts, Models: a) Carina350EM, REF 6060011 b) Carina350EML, REF 60600012 c) Carina350EE, REF 60600009

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3006633581	SUZHOU VICON INDUSTRIAL CO., LTD	SUZHOU Jiangsu, CN
3013002868	BRACE ALIGN	Soddy Daisy, TN, US
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011497619. Last updated year: 2026. Please use registration number 3011497619 when referencing this establishment in official correspondence.