Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3017274509

FEI Number

3017274509

Entity Name

BAOJI SHENGTAIKE INDUSTRY & TRADE CO. LTD.

City/State/Country

Baoji City Shanxi, CN

Establishment Address

No. 33, Baoti Road, High-tech Zone,, Baoji City Shanxi 721008, CN

Establishment Type(s)

Manufacture Medical Device,Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Baoji Shengtaike Industry & Trade Co. Ltd. (Owner Number: 10083631)

Owner / Operator Contact Address

No. 33, Baoti Road, High-tech Zone,, Baoji City, CN-SX 721008, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

DEVICE, PROSTHESIS ALIGNMENT JOINT, KNEE, EXTERNAL LIMB COMPONENT JOINT, ANKLE, EXTERNAL BRACE JOINT, HIP, EXTERNAL BRACE JOINT, HIP, EXTERNAL LIMB COMPONENT

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	2021-12-28
ISY	Joint, Knee, External Limb Component	Physical Medicine	Class 1	890.3420	2021-12-07
ITW	Joint, Ankle, External Brace	Physical Medicine	Class 1	890.3475	2022-12-05
ITS	Joint, Hip, External Brace	Physical Medicine	Class 1	890.3475	2022-12-05
ISL	Joint, Hip, External Limb Component	Physical Medicine	Class 1	890.3420	2021-12-07

Official Correspondent

Roy Tang

US Agent Details

Glenn Choi Email: gchoi2001@yahoo.com Phone: (714) 5240663

Related Public Records

Same Entity

Baoji Shengtaike Industry & Trade 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 3017274509. Last updated year: 2026. Please use registration number 3017274509 when referencing this establishment in official correspondence.