Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3040274588

FEI Number

3040274588

Entity Name

KOOLCARE MEDICAL EQUIPMENT (VIETNAM) COMPANY LIMITED

City/State/Country

Ho Chi Minh City, VN

Establishment Address

Factory A-17A-4-B,C, Lot A-17-CN, NX4 Road, Bau Bang Industrial Park, Bau Bang Commune, Ho Chi Minh City 75000, VN

Establishment Type(s)

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

Owner / Operator

Koolcare Medical Equipment (Vietnam) Company Limited (Owner Number: 10093838)

Owner / Operator Contact Address

Factory A-17A-4-B,C, Lot A-17-CN, NX4 Road, Bau Bang Industrial Park, Bau Bang Commune, Ho Chi Minh City, VN-SG 75000, VN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Pack, hot or cold, reusable ORTHOSIS, LUMBAR JOINT, ANKLE, EXTERNAL BRACE PACK, HEAT, MOIST JOINT, KNEE, EXTERNAL BRACE

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IME	Pack, Hot Or Cold, Reusable	Physical Medicine	Class 1	890.5700	2025-07-21
IQE	Orthosis, Lumbar	Physical Medicine	Class 1	890.3490	2025-07-21
ITW	Joint, Ankle, External Brace	Physical Medicine	Class 1	890.3475	2025-07-21
IMA	Pack, Heat, Moist	Physical Medicine	Class 1	890.5730	2025-07-21
ITQ	Joint, Knee, External Brace	Physical Medicine	Class 1	890.3475	2025-07-21

Official Correspondent

Peter Gao

US Agent Details

Fanny Zhao Business: J & F Technology Service Email: info@jf-yiliao.com Phone: (909) 5100201

Related Public Records

Same Entity

Koolcare Medical Equipment (Vietnam) Company Limited

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 3040274588. Last updated year: 2026. Please use registration number 3040274588 when referencing this establishment in official correspondence.