Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008388419

FEI Number

3008388419

Entity Name

Jinhua Twinstar Tools Co. Ltd

City/State/Country

jinhua Zhejiang, CN

Establishment Address

Tangya Industrial Area Jindong District, jinhua Zhejiang 321000, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

H&K International Trade Limited (China) (Owner Number: 10032555)

Owner / Operator Contact Address

15th floor, tower B, international plaza, 518, shuanglong south road, jinhua, CN-ZJ 321017, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

drive medical OLLIE'S BARGAIN OUTLET drive medical OLLIE'S BARGAIN OUTLET Goggle Bath Suction Handle CUP HOLDER SWIVEL NITRO

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ILS	Adaptor, Hygiene	Physical Medicine	Class 1	890.5050	2010-05-24
ITJ	Walker, Mechanical	Physical Medicine	Class 1	890.3825	2010-05-24
HOY	Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)	Ophthalmic	Class 1	886.4750	2020-04-07
IML	Armrest, Wheelchair	Physical Medicine	Class 1	890.3920	2021-04-27
KNN	Components, Wheelchair	Physical Medicine	Class 1	890.3920	2024-01-23

Official Correspondent

No official correspondent registered.

US Agent Details

shally dream Email: mljyangguang@msn.com Phone: (909) 2820679

Related Public Records

Same Entity

H&K International Trade Limited (China)

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3008386507	H&K INTERNATIONAL TRADE LIMITED (CHINA)	jinhua Zhejiang, CN

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K830425	Maddak, Inc.	TOILET SEAT RAISED	1983-05-09

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008388419. Last updated year: 2026. Please use registration number 3008388419 when referencing this establishment in official correspondence.