Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3016218294

FEI Number

3016218294

Entity Name

GUANGZHOU HOMESUN MEDICAL TECHNOLOGY CO., LTD

City/State/Country

Guangzhou Guangdong, CN

Establishment Address

Floor 7th,Tianxiang Business Building, No.28,Li Fu Road,Haizhu District, Guangzhou Guangdong 510250, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Guangzhou Homesun Medical Technology Co., Ltd (Owner Number: 10062023)

Owner / Operator Contact Address

Floor 7th,Tianxiang Business Building, No.28,Li Fu Road,Haizhu District, Guangzhou, CN-GD 510250, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

TA Smart Respiratory Exerciser T1 Respiratory Muscle Trainer, Model: PF-T1 SpiroLink 2 Pro Pulmonary Function Tester (Model :A9) SpiroLoop Portable Diagnostic Spirometer, Model: PF-A9 Breathing Mouthpiece (Model: Y1)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ISD	Exerciser, Measuring	Physical Medicine	Class 2	890.5360	2021-12-28
BTY	Calculator, Predicted Values, Pulmonary Function	Anesthesiology	Class 2	868.1890	2024-02-22
BYP	Mouthpiece, Breathing	Anesthesiology	Class 1	868.5620	2019-12-12

Official Correspondent

No official correspondent registered.

US Agent Details

Charles Mack Business: IRC USA Email: ircfda@gmail.com Phone: (931) 6254938

Related Public Records

Same Entity

Guangzhou Homesun Medical Technology 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 3016218294. Last updated year: 2026. Please use registration number 3016218294 when referencing this establishment in official correspondence.