Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

8043323

FEI Number

3006078362

Entity Name

FOURSTAR GROUP INC.

City/State/Country

TAIPEI, TW

Establishment Address

MING CHI BLDG.,12/F.,54 SEC.4, MIN SHENG E. ROAD, TAIPEI 105, TW

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

FOURSTAR GROUP INC. (Owner Number: 8043323)

Owner / Operator Contact Address

L101 Teva Cultural & Creative Plaza, No. 1010, Qiao Xiang Road, Futian District, Shenzhen, CN-GD 518034, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

COLD / HOT PAD MASSAGER STRIP Cool Bandage Cool Patch Renewed Energy TOOTHBRUSH TOOTHBRUSH Assured Renewed Energy

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IMD	Pack, Hot Or Cold, Disposable	Physical Medicine	Class 1	890.5710	2011-10-07
NGA	Test, Follicle Stimulating Hormone (Fsh), Over The Counter	Clinical Chemistry	Class 1	862.1300	2026-06-08
LYG	Massager, Therapeutic, Manual	Physical Medicine	Class 1	890.5660	2006-09-01
SDV	Clinical Electronic Thermometer	General Hospital	Class 2	880.2910	2025-07-07
KPD	Strip, Temperature, Forehead, Liquid Crystal	General Hospital	Class 2	880.2200	2012-02-03
OMW	Adhesive Backed Thermal Skin Patches	Physical Medicine	Class 1	890.5710	2011-12-20
FQM	Bandage, Elastic	General Hospital	Class 1	880.5075	2018-04-12
HHD	Pad, Menstrual, Unscented	Obstetrics/Gynecology	Class 1	884.5435	2023-01-17
ITQ	Joint, Knee, External Brace	Physical Medicine	Class 1	890.3475	2018-04-12
EFW	Toothbrush, Manual	Dental	Class 1	872.6855	2005-12-12
LAF	Gas Chromatography, Methamphetamine	Clinical Toxicology	Class 2	862.3610	2017-04-25
LDJ	Enzyme Immunoassay, Cannabinoids	Clinical Toxicology	Class 2	862.3870	2017-04-25
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2026-03-02
GFE	Brush, Dermabrasion, Powered	General, Plastic Surgery	Class 1	878.4820	2018-04-12
QUF	Hearing Aid, Air-Conduction, Over The Counter	Ear, Nose, Throat	Class 1	874.3300	2025-06-17
GAE	Snare, Surgical	General, Plastic Surgery	Class 1	878.4800	2022-07-27
LRR	First Aid Kit With Drug	Unknown	Class N	N/A	2024-12-23
ISA	Massager, Therapeutic, Electric	Physical Medicine	Class 1	890.5660	2009-06-01
ITW	Joint, Ankle, External Brace	Physical Medicine	Class 1	890.3475	2018-04-12
JHI	Visual, Pregnancy Hcg, Prescription Use	Clinical Chemistry	Class 2	862.1155	2019-03-22
LCX	Kit, Test, Pregnancy, Hcg, Over The Counter	Clinical Chemistry	Class 2	862.1155	2019-03-22
KCJ	Applicator, Ent	Ear, Nose, Throat	Class 1	874.5220	2023-05-08
IOY	Support, Arm	Physical Medicine	Class 1	890.3475	2018-04-12
GCY	Apparatus, Suction, Single Patient Use, Portable, Nonpowered	General, Plastic Surgery	Class 1	878.4680	2025-12-04
NAC	Dressing, Wound, Hydrophilic	General, Plastic Surgery	Class 1	878.4018	2022-07-27
MMD	Toothbrush, Ionic, Battery-Powered	Dental	Class 1	872.6865	2011-12-12
JES	Floss, Dental	Dental	Class 1	872.6390	2005-12-12
JEQ	Toothbrush, Powered	Dental	Class 1	872.6865	2009-08-26
NGE	Test, Luteinizing Hormone (Lh), Over The Counter	Clinical Chemistry	Class 1	862.1485	2017-04-25
LZB	Finger Cot	General Hospital	Class 1	880.6250	2023-04-21
KYR	Bag, Ice	General Hospital	Class 1	880.6050	2018-04-12
MEF	Ring, Teething, Non-Fluid Filled	Dental	Class 1	872.5550	2022-07-26
LCX	Kit, Test, Pregnancy, Hcg, Over The Counter	Clinical Chemistry	Class 2	862.1155	2015-08-10
DKZ	Enzyme Immunoassay, Amphetamine	Clinical Toxicology	Class 2	862.3100	2023-04-07
DJR	Enzyme Immunoassay, Methadone	Clinical Toxicology	Class 2	862.3620	2023-04-07
DIS	Enzyme Immunoassay, Barbiturate	Clinical Toxicology	Class 2	862.3150	2023-04-07
LDJ	Enzyme Immunoassay, Cannabinoids	Clinical Toxicology	Class 2	862.3870	2023-04-07
LAF	Gas Chromatography, Methamphetamine	Clinical Toxicology	Class 2	862.3610	2023-04-07
DJG	Enzyme Immunoassay, Opiates	Clinical Toxicology	Class 2	862.3650	2023-04-07
DIO	Enzyme Immunoassay, Cocaine And Cocaine Metabolites	Clinical Toxicology	Class 2	862.3250	2023-04-07
LCM	Enzyme Immunoassay, Phencyclidine	Unknown	Class U	N/A	2023-04-07
JXM	Enzyme Immunoassay, Benzodiazepine	Clinical Toxicology	Class 2	862.3170	2023-04-07
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2017-07-14
LCX	Kit, Test, Pregnancy, Hcg, Over The Counter	Clinical Chemistry	Class 2	862.1155	2026-06-08
ILW	Adaptor, Grooming	Physical Medicine	Class 1	890.5050	2022-07-27

Official Correspondent

Ted Conlon

US Agent Details

Edward Conlon Business: Fourstar Group USA, Inc. Email: corporate@fsgroup-inc.com Phone: (508) 4737388

Related Public Records

Same Entity

FOURSTAR GROUP INC.

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3007838093	Fourstar Group	Kowloon, HK

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K880871	John Wagner Associates, Inc.	GRABBER WARM PACK/MINI MINI HEATER/FOOT HEATER	1988-05-20
K823241	Kimberly-Clark Corp.	NEW FREEDOM THIN UNSCENTED MAXI PADS	1982-12-28
K973236	Procter & Gamble Co.	CREST TOOTHBRUSH WITH MICROSHIELD	1998-03-11
K112236	Guangzhou Wondfo Biotech Co., Ltd.	WONDFO METHYLENEDIOXYMETHAMPHETAMINE URINE TEST, WONDFO MORPHINE URINE TEST	2011-09-19
K110182	Guangzhou Wondfo Biotech Co., Ltd.	CANNABINOIDS URINE TEST	2011-05-20

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0505-2022	Philips North America Llc	1	Infa-Therm Transport Mattress, Reference Number 989805616831 1015
Z-0506-2022	Philips North America Llc	1	Infant Heel Warmers w/strap, Reference # 989805603201 1223
Z-0006-05	Abbott Health Products, Inc.	2	AxSYM Total B-hCG Reagent, Product list number: 7A59-22 and 7A59-21
Z-0042-2024	Universal Meditech Inc.	2	One Step Pregnancy Test REF 100-01
Z-0020-04	Vital Concepts, Inc.	1	Huntington Instruments brand Irrigation Aspiration System with Single Spike Tubing and 33 cm Probe, Disposable (single use only), sterile, latex free. Catalog # 55040. Labeled as Manufactured for Huntington Instruments, Ogden Utah.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8043323. Last updated year: 2026. Please use registration number 8043323 when referencing this establishment in official correspondence.