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Data / Medical devices / Hong Kong / Fourstar Group

Fourstar Group: FDA-registered device maker in Kowloon, Hong Kong, 13 510(k) clearances

Fourstar Group is registered with the FDA (registration 3007838093) in Kowloon, Hong Kong. It lists 49 device types. The FDA files 13 510(k) clearances under its listings, the newest dated August 14, 2023. Registered through 2026. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this oneWatch Fourstar Group
FDA registration number
3007838093
Address
41 Main Yue St Unit A, 8/F, Kaiser Estate Phase 1, Kowloon, Kowloon, Hong Kong, 999077
Owner or operator
FOURSTAR GROUP INC. (8043323)
Roles
Exporter to the US
First device listed
December 12, 2005
Registered through
2026
Brand names listed
COLD / HOT PAD, Cool Bandage, Cool Patch, MASSAGER, Magnifier, Swim Mask, TOOTHBRUSH, TheraPlus

Devices it lists

DeviceProduct codeClassRoleSource
Accessory, Surgical ApparelLYU1Exporter to the USaccessdata.fda.gov
Adaptor, GroomingILW1Exporter to the USaccessdata.fda.gov
Apparatus, Suction, Single Patient Use, Portable, NonpoweredGCY1Exporter to the USaccessdata.fda.gov
Applicator, EntKCJ1Exporter to the USaccessdata.fda.gov
Bag, IceKYR1Exporter to the USaccessdata.fda.gov
Brush, Dermabrasion, PoweredGFE1Exporter to the USaccessdata.fda.gov
Clinical Electronic ThermometerSDV2Exporter to the USaccessdata.fda.gov
Continuous Measurement ThermometerFLL2Exporter to the USaccessdata.fda.gov
Dressing, Wound, HydrophilicNAC1Exporter to the USaccessdata.fda.gov
Enzyme Immunoassay, AmphetamineDKZ2Exporter to the USaccessdata.fda.gov
Enzyme Immunoassay, BarbiturateDIS2Exporter to the USaccessdata.fda.gov
Enzyme Immunoassay, BenzodiazepineJXM2Exporter to the USaccessdata.fda.gov
Enzyme Immunoassay, CannabinoidsLDJ2Exporter to the USaccessdata.fda.gov
Enzyme Immunoassay, Cocaine And Cocaine MetabolitesDIO2Exporter to the USaccessdata.fda.gov
Enzyme Immunoassay, MethadoneDJR2Exporter to the USaccessdata.fda.gov
Enzyme Immunoassay, OpiatesDJG2Exporter to the USaccessdata.fda.gov
Enzyme Immunoassay, PhencyclidineLCMUExporter to the USaccessdata.fda.gov
Finger CotLZB1Exporter to the USaccessdata.fda.gov
First Aid Kit With DrugLRRNExporter to the USaccessdata.fda.gov
First Aid Kit Without DrugOHO1Exporter to the USaccessdata.fda.gov
Floss, DentalJES1Exporter to the USaccessdata.fda.gov
Gas Chromatography, MethamphetamineLAF2Exporter to the USaccessdata.fda.gov
Gown, Isolation, SurgicalFYC2Exporter to the USaccessdata.fda.gov
Hearing Aid, Air-Conduction, Over The CounterQUF1Exporter to the USaccessdata.fda.gov
Joint, Ankle, External BraceITW1Exporter to the USaccessdata.fda.gov
Joint, Knee, External BraceITQ1Exporter to the USaccessdata.fda.gov
Kit, Test, Pregnancy, Hcg, Over The CounterLCX2Exporter to the USaccessdata.fda.gov
Mask, ScavengingKHA1Exporter to the USaccessdata.fda.gov
Mask, SurgicalFXX2Exporter to the USaccessdata.fda.gov
Massager, Therapeutic, ManualLYG1Exporter to the USaccessdata.fda.gov
Pack, Hot Or Cold, DisposableIMD1Exporter to the USaccessdata.fda.gov
Pack, Hot Or Cold, ReusableIME1Exporter to the USaccessdata.fda.gov
Pad, Menstrual, UnscentedHHD1Exporter to the USaccessdata.fda.gov
Polymer Patient Examination GloveLZA1Exporter to the USaccessdata.fda.gov
Protector, Hearing (Insert)EWDUExporter to the USaccessdata.fda.gov
Reader, Bar, OphthalmicHJY1Exporter to the USaccessdata.fda.gov
Respirator, SurgicalMSH2Exporter to the USaccessdata.fda.gov
Ring, Teething, Non-Fluid FilledMEF1Exporter to the USaccessdata.fda.gov
Snare, SurgicalGAE1Exporter to the USaccessdata.fda.gov
Sunglasses (Non-Prescription Including Photosensitive)HQY1Exporter to the USaccessdata.fda.gov
Support, ArmIOY1Exporter to the USaccessdata.fda.gov
Tampon, Menstrual, UnscentedHEB2Exporter to the USaccessdata.fda.gov
Tape And Bandage, AdhesiveKGX1Exporter to the USaccessdata.fda.gov
Test, Follicle Stimulating Hormone (Fsh), Over The CounterNGA1Exporter to the USaccessdata.fda.gov
Test, Luteinizing Hormone (Lh), Over The CounterNGE1Exporter to the USaccessdata.fda.gov
Toothbrush, ManualEFW1Exporter to the USaccessdata.fda.gov
Toothbrush, PoweredJEQ1Exporter to the USaccessdata.fda.gov
Vinyl Patient Examination GloveLYZ1Exporter to the USaccessdata.fda.gov
Visual, Pregnancy Hcg, Prescription UseJHI2Exporter to the USaccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
August 14, 2023K231341Organic cotton tampon, Viscose tamponHEBSubstantially EquivalentZhejiang Tianqing Manufacturing Technology Group Co., Ltd.accessdata.fda.gov
June 30, 2022K212418hCG One Step Pregnancy TestLCXSubstantially EquivalentHealstone Biotech, Inc.accessdata.fda.gov
May 27, 2019K182515Surgical Face MaskFXXSubstantially EquivalentWuhan Dymex Healthcare Co., Ltd.accessdata.fda.gov
February 15, 2018K171535SURGICAL ISOLATION GOWNFYCSubstantially EquivalentJingzhou Haixin Green Cross Medical Products Co., Ltd.accessdata.fda.gov
August 24, 2016K160802Infrared Forehead Thermometer, FT-100AFLLSubstantially EquivalentHangzhou Universal Electronic Co., Ltd.accessdata.fda.gov
May 23, 2016K153597Healgen Multi-Drug Urine Test Cup, Healgen Multi-Drug Urine Test Dip CardJXMSubstantially EquivalentHealgen Scientific,, LLCaccessdata.fda.gov
August 7, 2015K150022Wondfo One Step HCG Urine Pregnancy Test Strip, Wondfo One Step HCG Urine Pregnancy Test Cassette, Wondfo One Step HCG Urine Pregnancy Test MidstreamLCXSubstantially EquivalentGuangzhou Wondfo Biotech Co., Ltd.accessdata.fda.gov
March 25, 2015K142892Powder-free Clear Vinyl Patient Examination GlovesLYZSubstantially EquivalentShenyi (Shandong) Plastic Products Co., Ltd.accessdata.fda.gov
June 6, 2014K140546HEALGEN THC ONE STEP MARIJUANA TEST , HEALGEN MAMP ONE STEP METHAMPHETAMINE TESTLDJSubstantially EquivalentHealgen Scientific,, LLCaccessdata.fda.gov
July 17, 2013K123787GREENCROSS SURGICAL MASKFXXSubstantially EquivalentJingzhou Haixin Green Cross Medical Products Co.,Laccessdata.fda.gov
April 10, 2013K123703HEALGEN HCG ONE STEP PREGNANCY TEST (STRIP), HEALGEN HCG ONE STEP PREGNANCY TEST (CASSETTE)LCXSubstantially EquivalentHealgen Scientific,, LLCaccessdata.fda.gov
April 15, 2011K110921NITRILE POWDER-FREE EXAMINATION GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUGSLZASubstantially EquivalentCardinal Health, Inc.accessdata.fda.gov
June 10, 2003K023755WINNER EAR LOOP PROCEDURE MASK, TIE-ON SURGICAL MASK & EAR LOOP PROCEDURE MASK WITH SHIELDFXXSubstantially EquivalentWinner Industries (Shenzhen) Co., Ltd.accessdata.fda.gov

Compare with other makers

Updated August 14, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.