Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007728095

FEI Number

3007728095

Entity Name

VISCOUNT HI-TECH (HUIZHOU) CO., LTD.

City/State/Country

Huizhou Guangdong, CN

Establishment Address

Yangna Industrial Area, Danshui Town,, Huiyang District,, Huizhou Guangdong 516211, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

VISCOUNT HI-TECH (HUIZHOU) CO., LTD (Owner Number: 10028912)

Owner / Operator Contact Address

Yangna Industrial Area, Danshui Town,, Huiyang District,, Huizhou, CN-GD 516211, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

CUFF, PUSHER, WHEELCHAIR DEVICE, ANTI-TIP, WHEELCHAIR BRAKE, EXTENSION, WHEELCHAIR ARMBOARD, WHEELCHAIR ACCESSORIES, WHEELCHAIR FOOTREST, WHEELCHAIR HILL HOLDER, WHEELCHAIR SUPPORT, HEAD AND TRUNK, WHEELCHAIR CUSHION, WHEELCHAIR COMPONENTS, WHEELCHAIR ARMREST, WHEELCHAIR BELT, WHEELCHAIR HANDRIM, WHEELCHAIR

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
INC	Cuff, Pusher, Wheelchair	Physical Medicine	Class 1	890.3910	2012-09-06
IMR	Device, Anti-Tip, Wheelchair	Physical Medicine	Class 1	890.3920	2012-09-06
IMW	Brake, Extension, Wheelchair	Physical Medicine	Class 1	890.3920	2012-09-06
IMY	Armboard, Wheelchair	Physical Medicine	Class 1	890.3910	2012-09-06
KNO	Accessories, Wheelchair	Physical Medicine	Class 1	890.3910	2012-09-06
IMM	Footrest, Wheelchair	Physical Medicine	Class 1	890.3920	2012-09-06
INA	Hill Holder, Wheelchair	Physical Medicine	Class 1	890.3920	2012-09-06
IMS	Support, Head And Trunk, Wheelchair	Physical Medicine	Class 1	890.3910	2012-09-06
IMP	Cushion, Wheelchair	Physical Medicine	Class 1	890.3920	2012-09-06
KNN	Components, Wheelchair	Physical Medicine	Class 1	890.3920	2012-09-06
IML	Armrest, Wheelchair	Physical Medicine	Class 1	890.3920	2012-09-06
IQB	Belt, Wheelchair	Physical Medicine	Class 1	890.3920	2012-09-06
IMO	Handrim, Wheelchair	Physical Medicine	Class 1	890.3920	2012-09-06

Official Correspondent

Janet Chou

US Agent Details

Charles Tam Business: Gallop Cycle Corporation Email: ctam@gallopcorp.com Phone: (310) 8854300

Related Public Records

Same Entity

VISCOUNT HI-TECH (HUIZHOU) 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 3007728095. Last updated year: 2026. Please use registration number 3007728095 when referencing this establishment in official correspondence.