Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3045063911

FEI Number

3045063911

Entity Name

OYMOTION TECHNOLOGIES CO., LTD.

City/State/Country

shanghai, CN

Establishment Address

Ziping Road, Pudong District, 201318 Shanghai,PEOPLE'S REPUBLIC OF CHINA, shanghai 201318, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

OYMotion Technologies Co., Ltd. (Owner Number: 10095733)

Owner / Operator Contact Address

Ziping Road, Pudong District, 201318 Shanghai,PEOPLE'S REPUBLIC OF CHINA, shanghai, CN-SH 201318, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Intelligent Bionic Hand(OH-A001LS;OH-A001LB;OH-A001RS;OH-A001RB;OH-S001LS;OH-S001RS) Elbow Continuous Passive Motion Machine(OYEM-1000-LMSW;OYEM-1000-RMSW)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IQZ	Hand, External Limb Component, Powered	Physical Medicine	Class 1	890.3420	2026-04-20
KFW	Assembly, Shoulder/Elbow/Forearm/Wrist/Hand, Powered	Physical Medicine	Class 1	890.3420	2026-04-20

Official Correspondent

Minglei Chen

US Agent Details

James Wang Business: LLINS TECHNOLOGY INC Email: fda-rep@llins-tech.com Phone: (720) 2171916

Related Public Records

Same Entity

OYMotion Technologies 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 3045063911. Last updated year: 2026. Please use registration number 3045063911 when referencing this establishment in official correspondence.