Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010182295

FEI Number

3010182295

Entity Name

ZHANGPU ORTHOLIFE REHABILITATION CO., LTD

City/State/Country

Zhangzhou Fujian, CN

Establishment Address

Sui-An Industry Park, Zhangpu County, Zhangzhou Fujian 363200, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Zhangpu Ortholife Rehabilitation Co., Ltd (Owner Number: 10043834)

Owner / Operator Contact Address

Sui-An Industry Park, Zhangpu County, Zhangzhou, CN-FJ 363200, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Ortholife Ortholife Ortholife Ortholife Ortholife Ortholife Ortholife Ortholife Ortholife Ortholife Ortholife Ortholife Ortholife Ortholife Ortholife Ortholife Ortholife Ortholife

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ITS	Joint, Hip, External Brace	Physical Medicine	Class 1	890.3475	2013-03-27
ILE	Sling, Arm, Overhead Supported	Physical Medicine	Class 1	890.3475	2013-03-27
FZF	Splint, Extremity, Inflatable, External	General, Plastic Surgery	Class 1	878.3900	2013-03-27
ILI	Sling, Arm	Physical Medicine	Class 1	890.3640	2013-03-27
ITW	Joint, Ankle, External Brace	Physical Medicine	Class 1	890.3475	2013-03-27
ISR	Band Or Belt, Pelvic Support	Physical Medicine	Class 1	890.3025	2013-03-27
ILH	Splint, Hand, And Components	Physical Medicine	Class 1	890.3475	2013-03-27
KIC	Cushion, Flotation	Physical Medicine	Class 1	890.3175	2013-03-27
IQI	Orthosis, Limb Brace	Physical Medicine	Class 1	890.3475	2013-03-27
IQJ	Splint, Clavicle	Physical Medicine	Class 1	890.3490	2013-03-27
KNP	Orthosis, Corrective Shoe	Physical Medicine	Class 1	890.3475	2013-03-27
IOY	Support, Arm	Physical Medicine	Class 1	890.3475	2013-03-27
IQF	Orthosis, Cervical-Thoracic, Rigid	Physical Medicine	Class 1	890.3490	2013-03-27
IOZ	Splint, Abduction, Congenital Hip Dislocation	Physical Medicine	Class 1	890.3665	2013-03-27
ITQ	Joint, Knee, External Brace	Physical Medicine	Class 1	890.3475	2013-03-27
NJB	Orthosis, Truncal, For Dysmenorrhea	Physical Medicine	Class 1	890.3490	2013-03-27
ITC	Stirrup, External Brace Component	Physical Medicine	Class 1	890.3410	2013-03-27
IPY	Orthosis, Lumbo-Sacral	Physical Medicine	Class 1	890.3490	2013-03-27

Official Correspondent

David Wu

US Agent Details

Glenn Choi Business: ST&G USA Corporation Email: gchoi2001@yahoo.com Phone: (714) 5240663

Related Public Records

Same Entity

Zhangpu Ortholife Rehabilitation 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 3010182295. Last updated year: 2026. Please use registration number 3010182295 when referencing this establishment in official correspondence.