Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3031606416

FEI Number

3031606416

Entity Name

ORTHOTECH REHABILITATION CO., LTD.

City/State/Country

Xiamen Fujian, CN

Establishment Address

Building #1, No. 69 Xinyuan South Rd., Xinyang Industry Section, Haicang, Xiamen China., Xiamen Fujian 361000, CN

Establishment Type(s)

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

Owner / Operator

Orthotech Rehabilitation Co., Ltd. (Owner Number: 10090883)

Owner / Operator Contact Address

Building #1, No. 69 Xinyuan South Rd., Xinyang Industry Section, Haicang, Xiamen China., Xiamen, CN-FJ 361000, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

orthotech orthotech orthotech orthotech ORTHOTECH orthotech orthotech orthotech orthotech orthotech orthotech ORTHOTECH orthotech orthotech orthotech orthotech orthotech orthotech orthotech

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KHY	Cane, Safety Walk	Physical Medicine	Class 1	890.3075	2024-06-03
ISR	Band Or Belt, Pelvic Support	Physical Medicine	Class 1	890.3025	2024-06-03
ITQ	Joint, Knee, External Brace	Physical Medicine	Class 1	890.3475	2024-05-28
IQJ	Splint, Clavicle	Physical Medicine	Class 1	890.3490	2024-05-28
ILI	Sling, Arm	Physical Medicine	Class 1	890.3640	2024-06-03
KNP	Orthosis, Corrective Shoe	Physical Medicine	Class 1	890.3475	2024-06-03
IQK	Orthosis, Cervical	Physical Medicine	Class 1	890.3490	2024-05-28
ILE	Sling, Arm, Overhead Supported	Physical Medicine	Class 1	890.3475	2024-05-28
MRI	Orthosis, Truncal/Orthosis, Limb	Physical Medicine	Class 1	890.3490	2024-06-03
IQO	Device, Prosthesis Alignment	Physical Medicine	Class 1	890.3025	2024-06-03
HST	Apparatus, Traction, Non-Powered	Orthopedic	Class 1	888.5850	2024-06-03
ITM	Cage, Knee	Physical Medicine	Class 1	890.3475	2024-06-03
ITW	Joint, Ankle, External Brace	Physical Medicine	Class 1	890.3475	2024-06-03
KIC	Cushion, Flotation	Physical Medicine	Class 1	890.3175	2024-06-03
ILH	Splint, Hand, And Components	Physical Medicine	Class 1	890.3475	2024-05-28
IQI	Orthosis, Limb Brace	Physical Medicine	Class 1	890.3475	2024-05-28
IQE	Orthosis, Lumbar	Physical Medicine	Class 1	890.3490	2024-05-28
IPY	Orthosis, Lumbo-Sacral	Physical Medicine	Class 1	890.3490	2024-06-03
ISH	Component, External, Limb, Ankle/Foot	Physical Medicine	Class 1	890.3420	2024-06-03

Official Correspondent

Ramon Tseng

US Agent Details

GLENN CHOI Business: ST&G USA Corporation Email: glenn@stngco.com Phone: (714) 5240663

Related Public Records

Same Entity

Orthotech Rehabilitation Co., Ltd.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0006-2025	Ossur H F Grjothals 5 Reykjavik Iceland	1	Miami J Select Collar, Catalog: MJS-101; Miami J Select Collar Set, Catalog: MJSR-101

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3031606416. Last updated year: 2026. Please use registration number 3031606416 when referencing this establishment in official correspondence.