Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3034731542

FEI Number

3034731542

Entity Name

GUANCHI TECHNOLOGY (HEBEI) CO., LTD.

City/State/Country

Hengshui Hebei, CN

Establishment Address

No. 8 of workshop No. 7 in the amusement equipment business incubator park,on the east side of Weisan Road, south side of Guihuasi Road, High-tech Development Zone, Jizhou District, Hengshui Hebei 053200, CN

Establishment Type(s)

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

Owner / Operator

Guanchi Technology (Hebei) Co., Ltd. (Owner Number: 10092186)

Owner / Operator Contact Address

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Medical fixation band Cane Truncal orthosis Orthosis Walker Manual nursing bed Crutch Electric nursing bed

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ISR	Band Or Belt, Pelvic Support	Physical Medicine	Class 1	890.3025	2024-12-12
IPS	Cane	Physical Medicine	Class 1	890.3075	2024-12-12
MRI	Orthosis, Truncal/Orthosis, Limb	Physical Medicine	Class 1	890.3490	2024-12-12
IQI	Orthosis, Limb Brace	Physical Medicine	Class 1	890.3475	2024-12-12
ITJ	Walker, Mechanical	Physical Medicine	Class 1	890.3825	2024-12-12
FNJ	Bed, Manual	General Hospital	Class 1	880.5120	2024-12-12
IPR	Crutch	Physical Medicine	Class 1	890.3150	2024-12-12
LLI	Bed, Therapeutic, Ac-Powered, Adjustable Home-Use	General Hospital	Class 2	880.5100	2024-12-12

Official Correspondent

Zhensheng Shi

US Agent Details

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

Related Public Records

Same Entity

Guanchi Technology (Hebei) 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 3034731542. Last updated year: 2026. Please use registration number 3034731542 when referencing this establishment in official correspondence.