Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3031170295

FEI Number

3031170295

Entity Name

XIAMEN BENLEI MEDICAL TECHNOLOGY CO., LTD.

City/State/Country

Xiamen City Fujian, CN

Establishment Address

68 Meixi Road, Siming Industrial Park, Third Floor, Room 3, Xike Town, Tongan District, Xiamen City Fujian 361109, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Xiamen Benlei Medical Technology Co., Ltd. (Owner Number: 10090326)

Owner / Operator Contact Address

68 Meixi Road, Siming Industrial Park, Third Floor, Room 3, Xike Town, Tongan District, Xiamen City, CN-FJ 361109, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Knee Stabilizer, Knee Brace, Knee Replacement Recovery Aids, Knee Surgery Recovery Equipment Neck Stabilizer, Over-door neck traction device, Neck Supports, Shoulder Stabilizer, Shoulder Supports Cervical Orthotic Traction Block, Lumbar Orthotic Traction Block, Pro-Lordotic Neck Exerciser, Neck Stretcher Strap, Y-Strap Spine Decompression Tool, Cervical Neck Traction Device, Over Door Neck Traction Device Wrist Stabilizer, Wrist Brace, Arthritis Gloves, Arm Supports, Elbow Braces, Finger Splints, Wrist Brace

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ITQ	Joint, Knee, External Brace	Physical Medicine	Class 1	890.3475	2024-03-12
IQF	Orthosis, Cervical-Thoracic, Rigid	Physical Medicine	Class 1	890.3490	2024-03-12
HST	Apparatus, Traction, Non-Powered	Orthopedic	Class 1	888.5850	2026-01-07
ILH	Splint, Hand, And Components	Physical Medicine	Class 1	890.3475	2024-03-12

Official Correspondent

Xiangyu Luo

US Agent Details

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

Related Public Records

Same Entity

Xiamen Benlei Medical Technology 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 3031170295. Last updated year: 2026. Please use registration number 3031170295 when referencing this establishment in official correspondence.