Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3016796158

FEI Number

3016796158

Entity Name

DONGGUAN ZHI QI HANDBAG CO., LTD

City/State/Country

Dongguan Guangdong, CN

Establishment Address

Jiangbian village Dongjiang Avenue Haikou Industrial Zone, Qishi Town, Dongguan Guangdong 523950, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Dongguan Zhi Qi Handbag Co., Ltd (Owner Number: 10068020)

Owner / Operator Contact Address

Jiangbian village Dongjiang Avenue Haikou Industrial Zone, Qishi Town, Dongguan, CN-GD 523950, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

MyoJaw Device Relief Pak Donjoy, ISOFORM

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ION	Exerciser, Non-Measuring	Physical Medicine	Class 1	890.5370	2024-12-17
ILZ	Accessories, Traction	Physical Medicine	Class 1	890.5925	2021-10-19
IMA	Pack, Heat, Moist	Physical Medicine	Class 1	890.5730	2023-01-06
IQE	Orthosis, Lumbar	Physical Medicine	Class 1	890.3490	2023-10-31

Official Correspondent

Amy XU

US Agent Details

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

Related Public Records

Same Entity

Dongguan Zhi Qi Handbag 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 3016796158. Last updated year: 2026. Please use registration number 3016796158 when referencing this establishment in official correspondence.