Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3015543909

FEI Number

3015543909

Entity Name

HEPTEX INDUSTRY COMPANY LIMITED

City/State/Country

Viet Tri Phu Tho, VN

Establishment Address

2187A Hung Vuong Street, Gia Cam Ward, Viet Tri Phu Tho 29000, VN

Establishment Type(s)

Manufacture Medical Device,Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

HEPTEX INDUSTRY COMPANY LIMITED (Owner Number: 10060915)

Owner / Operator Contact Address

2187A Hung Vuong Street, Gia Cam Ward, Viet Tri, VN-68 29000, VN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

ARM ELEVATOR SLING,ARM ELEVATOR STING AC SPORT BRACE Super Knee ANKLE BRACES,MALLEOFORCE BUCKS TRACTION,KNEE SLING

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ILE	Sling, Arm, Overhead Supported	Physical Medicine	Class 1	890.3475	2019-07-12
ILI	Sling, Arm	Physical Medicine	Class 1	890.3640	2019-07-12
ITQ	Joint, Knee, External Brace	Physical Medicine	Class 1	890.3475	2021-08-11
IQE	Orthosis, Lumbar	Physical Medicine	Class 1	890.3490	2025-11-25
ITW	Joint, Ankle, External Brace	Physical Medicine	Class 1	890.3475	2019-07-12
HST	Apparatus, Traction, Non-Powered	Orthopedic	Class 1	888.5850	2019-07-12

Official Correspondent

YC Kwok

US Agent Details

Amy XU Business: BARBARAS DEVELOPMENT, INC. Email: amyxu@bd.inc Phone: (888) 9025500

Related Public Records

Same Entity

HEPTEX INDUSTRY COMPANY LIMITED

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 3015543909. Last updated year: 2026. Please use registration number 3015543909 when referencing this establishment in official correspondence.