Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3015501220

FEI Number

3015501220

Entity Name

GABOSS INTERNATIONAL LIMITED

City/State/Country

KOWLOON Xinjiang, CN

Establishment Address

19H MAXGRAND PLAZA NO.3 TAI YAU STREET SAN PO KONG, KOWLOON Xinjiang 999077, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

GABOSS INTERNATIONAL LIMITED (Owner Number: 10062777)

Owner / Operator Contact Address

19H MAXGRAND PLAZA NO.3 TAI YAU STREET SAN PO KONG, KOWLOON, CN-XJ 999077, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Silver Nursing Cups mask Freestyle Flex Connector Wearable Milk Collector mask Massage Gun Warming Lactation Massager massage chair sauna blanket Breast Pump tooth cleaner

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NXH	Nursing Pad, Cohesive Gel	General Hospital	Class 1	880.5630	2023-02-26
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	2020-03-07
PWA	Breast Pump Accessory, Milk Expression Aid, Via Positive Pressure	Obstetrics/Gynecology	Class 1	884.5150	2023-02-26
OEA	Non-Surgical Gown	General, Plastic Surgery	Class 1	878.4040	2020-03-07
ISA	Massager, Therapeutic, Electric	Physical Medicine	Class 1	890.5660	2020-03-07
IRT	Pad, Heating, Powered	Physical Medicine	Class 2	890.5740	2024-05-09
HGX	Pump, Breast, Powered	Obstetrics/Gynecology	Class 2	884.5160	2023-02-26
EMN	Scaler, Periodontic	Dental	Class 1	872.4565	2024-04-27

Official Correspondent

Jian Zhang

US Agent Details

Jinxiu Luo Business: 762 Email: winter.wang@sft-lab.com.cn Phone: (762) 2222081

Related Public Records

Same Entity

GABOSS INTERNATIONAL LIMITED

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K881862	Thermo Body Wrap Systems, Inc.	THERMO-BODY-WRAP SYSTEM	1988-10-13
K190465	Hygeia II Medical Group, Inc.	Evolve Breast Pump	2019-10-18
K021739	Limerick, Inc.	LIMERICK POWERED ELECTRIC BREAST PUMP MODEL 1002	2003-01-10
K851721	Artiberia	1200/1 TO 1240/15 VARIOUS TYPES OF DENTAL SCALERS	1985-07-02

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3002907620	Sterigenics US LLC	West Memphis, AR, US
3010183315	Fujian Hui'an Hecheng Household Products Co., Ltd	Quanzhou Fujian, CN
1643116	voss medical products	San Antonio, TX, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015501220. Last updated year: 2026. Please use registration number 3015501220 when referencing this establishment in official correspondence.