Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013014172

FEI Number

3013014172

Entity Name

Fujian Guozi Rehabilitation Medical co., ltd

City/State/Country

Fuzhou Fujian, CN

Establishment Address

No.50 Gaofeng SouthLane, Westgate, Fuzhou Fujian 350001, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Fujian Guozi Rehabilitation Medical co.,ltd (Owner Number: 10052023)

Owner / Operator Contact Address

No.50 Gaofeng SouthLane Westgate, Fuzhou, CN-FJ 350001, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Modular Clutch Lock 1102 SACH foot 1MA Pyramid Multiflex Ankle 1M Multiflex Foot 2N02 Foot Adapter for EZ Step foot Quantum Foot Shell 2SR420 Pneumatic Knee Joint 1FS Carbon Fiber Foot 1101 single axis foot Socket Accessory 1FS Bosun Foot (Dynamic carbon foot) Hip joint 1FC freedom footshell 1FO Ossur footshell Lower limb metal adapters Hand RGO and Orthotic Joint Knee Joint Silicone Gloves Fabrication tools Sanding Toold for Roubers Children Adapters Prosthetics cosmesis Upper limb Adapters 1P01 Pirogof foot Prosthetics Accessory Prosthetics Multicolor Pad 1FC40/1FC45/1FC60 Carbon fiber foot 1E20 Keel For EZ Step Foot

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IQO	Device, Prosthesis Alignment	Physical Medicine	Class 1	890.3025	2025-07-08
ISH	Component, External, Limb, Ankle/Foot	Physical Medicine	Class 1	890.3420	2016-06-01

Official Correspondent

Lucinda Chen

US Agent Details

Leeyeo Kee Business: Regrek LLC Email: regrek.cs@hotmail.com Phone: (302) 6089028

Related Public Records

Same Entity

Fujian Guozi Rehabilitation Medical 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 3013014172. Last updated year: 2026. Please use registration number 3013014172 when referencing this establishment in official correspondence.