ZHEJIANG HFIZER MEDICAL EQUIPMENT CO.,LTD

FDA Device Registration & Listing · Yongkang City Zhejiang, CN · Registration 3031595780

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3031595780
FEI Number
3031595780
Entity Name
ZHEJIANG HFIZER MEDICAL EQUIPMENT CO.,LTD
City/State/Country
Yongkang City Zhejiang, CN
Establishment Address
Yunliu Road, Baiyun Industrial Functional Zone, Jiangnan Street,, Yongkang City Zhejiang 321300, CN
Establishment Type(s)
Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device
Owner / Operator
Zhejiang Hfizer Medical Equipment CO.,LTD (Owner Number: 10091056)
Owner / Operator Contact Address
Yunliu Road, Baiyun Industrial Functional Zone, Jiangnan Street,, Yongkang City, CN-ZJ 321300, CN
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K242136
PMA Number
N/A

All Registered Proprietary Names

Electric wheelchair Walker, Wheelchair, Rollator Lift chair Electric wheelchair (C001)

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
ITI Wheelchair, Powered Physical Medicine Class 2 890.3860 2024-06-23
ITJ Walker, Mechanical Physical Medicine Class 1 890.3825 2024-12-12
INO Chair, Positioning, Electric Physical Medicine Class 2 890.3110 2026-01-26
ITI Wheelchair, Powered Physical Medicine Class 2 890.3860 2024-12-02

Official Correspondent

Xiaoneng Hu

US Agent Details

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

Related Public Records

Same Entity

Zhejiang Hfizer Medical Equipment CO.,LTD
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K853594 Vessa , Ltd. VESSA FLIVVA 1985-09-24
K142783 Heartway Medical Products Co., Ltd. HEARTWAY Electrically Powered Wheelchair P27 2015-06-12

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0005-2018 Permobil, Ab Arvaltsvagen 10 2
Electric Wheelchairs: a) C300 CORPUS II b) C350 CORPUS II c) C400 CORPUS II d) C400 CORPUS II LR e) C500 CORPUS II f) C500 CORPUS II LR
Z-0006-2018 Permobil, Ab Arvaltsvagen 10 2
Electric Wheelchair bases: a) C300 b) C350 c) C400 d) C500
Z-0039-2007 Eagle Parts and Products 2
Eagle Parts and Products Model 624EZ Power Wheel Chairs with internally threaded wheel mount motors.
Z-0040-2007 Eagle Parts and Products 2
Eagle Parts and Products Model 624Mini Power Wheel Chairs with internally threaded wheel mount motors.

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3002667030 TUNG KENG ENTERPRISE CO., LTD. Taichung City, TW
3043165991 HEBEI DANSONG MEDICAL TECHNOLOGY CO., LTD. SHIJIAZHUANG Hebei, CN
3036988603 SHENZHEN YATTLL INDUSTRY CO., LTD Shenzhen Guangdong, CN
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3031595780. Last updated year: 2026. Please use registration number 3031595780 when referencing this establishment in official correspondence.
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