Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009560029

FEI Number

3009560029

Entity Name

PINTOLI ENTERPRISES CO., LTD.

City/State/Country

Changhua County, TW

Establishment Address

No.23, Ln. 787, Sec. 1, Shedou Rd.,, No.45, Zhongxing Rd., Shetou Township, Changhua County 511, TW

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

PINTOLI ENTERPRISES CO., LTD. (Owner Number: 10040258)

Owner / Operator Contact Address

No.23, Ln. 787, Sec. 1, Shedou Rd.,, Shetou Township, Changhua County, TW-NOTA 511, TW

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

PINTOLI PINTOLI PINTOLI PINTOLI PINTOLI

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ITQ	Joint, Knee, External Brace	Physical Medicine	Class 1	890.3475	2021-03-12
ILG	Stocking, Elastic	Physical Medicine	Class 1	890.3475	2012-03-24
DWL	Stocking, Medical Support (To Prevent Pooling Of Blood In Legs)	General Hospital	Class 2	880.5780	2019-10-07
FQL	Stocking, Medical Support (For General Medical Purposes)	General Hospital	Class 1	880.5780	2012-03-24
IQI	Orthosis, Limb Brace	Physical Medicine	Class 1	890.3475	2021-03-12

Official Correspondent

Chang Wayne

US Agent Details

Wilson Chang Email: COMPLIANCE@I-VISTACORP.COM Phone: (512) 7889037

Related Public Records

Same Entity

PINTOLI ENTERPRISES 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 3009560029. Last updated year: 2026. Please use registration number 3009560029 when referencing this establishment in official correspondence.