Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9710137

FEI Number

3003050402

Entity Name

PRO LIMB INTERNATIONAL CORP.

City/State/Country

NEW TAIPEI CITY, TW

Establishment Address

No. 20-3, SINSINGSTR. SHULIN DIST., NEW TAIPEI CITY 23877, TW

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

PRO LIMB INTERNATIONAL CORP. (Owner Number: 10053959)

Owner / Operator Contact Address

No. 20-3, SINSINGSTR. SHULIN DIST., NEW TAIPEI CITY, TW-TPE 23877, TW

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

ISY / JOINT, KNEE, EXTERNAL LIMB COMPONENT

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ISY	Joint, Knee, External Limb Component	Physical Medicine	Class 1	890.3420	2017-01-26

Official Correspondent

Hsin-Tsai Shen

US Agent Details

Katla Axelsdottir Business: Ossur Email: kaxelsdottir@ossur.com Phone: (949) 3823833

Related Public Records

Same Entity

PRO LIMB INTERNATIONAL CORP.

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 9710137. Last updated year: 2026. Please use registration number 9710137 when referencing this establishment in official correspondence.