Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3026020435

FEI Number

3026020435

Entity Name

Good Time Health Care Products Co., Ltd.

City/State/Country

Thu Dau Mot City Binh Duong, VN

Establishment Address

Factory Units 5 and 7, Tien Phong 5 Street, Phase 1A, Mapletree Binh Duong Industrial Park, Hoa Phu Ward, Thu Dau Mot City Binh Duong 75114, VN

Establishment Type(s)

Manufacture Medical Device,Manufacture Medical Device for Another Party (Contract Manufacturer),Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

Good Time Health Care Products Co., Ltd. (Owner Number: 10087080)

Owner / Operator Contact Address

Factory Units 5 and 7, Tien Phong 5 Street, Phase 1A, Mapletree Binh Duong Industrial Park, Hoa Phu Ward, Thu Dau Mot City, VN-57 75114, VN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

STOCKING, MEDICAL SUPPORT(FOR GENERAL MEDICAL PURPOSES) JOINT, KNEE, EXTERNAL BRACE Back Support/ Waist Support/ Lumbar Support ORTHOSIS, LIMB BRACE JOINT, ANKLE, EXTERNAL BRACE Nuroo Pocket SPLINT, HAND, AND COMPONENTS

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FQL	Stocking, Medical Support (For General Medical Purposes)	General Hospital	Class 1	880.5780	2023-01-10
ITQ	Joint, Knee, External Brace	Physical Medicine	Class 1	890.3475	2023-01-10
IQE	Orthosis, Lumbar	Physical Medicine	Class 1	890.3490	2025-07-17
IQI	Orthosis, Limb Brace	Physical Medicine	Class 1	890.3475	2023-01-10
ITW	Joint, Ankle, External Brace	Physical Medicine	Class 1	890.3475	2023-01-10
HEF	Binder, Breast	General Hospital	Class 1	880.5160	2025-12-25
ILH	Splint, Hand, And Components	Physical Medicine	Class 1	890.3475	2023-01-10

Official Correspondent

Bin Wu

US Agent Details

FANFEI LIU Email: U.S.agent@frosatechnology.com Phone: (626) 8261385

Related Public Records

Same Entity

Good Time Health Care Products 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 3026020435. Last updated year: 2026. Please use registration number 3026020435 when referencing this establishment in official correspondence.