FDA Registration
Active
🇹🇼 Taiwan
FOURSTAR GROUP INC.
Reg #: 8043323
·
FEI: 3006078362
·
Expires 2026
Products
46
Proprietary Names
10
Establishment Types
2
Classifications
46
Registration Details
- Registration Name
- FOURSTAR GROUP INC.
- Registration Number
- 8043323
- FEI Number
- 3006078362
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- MING CHI BLDG.,12/F.,54 SEC.4, MIN SHENG E. ROAD
- City
- TAIPEI
- Country
- TW
Regulatory Submissions
- 510(k) Number
- K140546
Owner / Operator
- Firm Name
- FOURSTAR GROUP INC.
- Operator Number
- 8043323
- Address
- L101 Teva Cultural & Creative Plaza, No. 1010, Qiao Xiang Road, Futian District
- City
- Shenzhen
- State
- Guangdong
- Postal Code
- 518034
- Country
- CN
- Correspondent
- Ted Conlon
US Agent
- Business Name
- Fourstar Group USA, Inc.
- Contact Name
- Edward Conlon
- Address
- 189 Main St Ste 31
- City
- Milford
- State
- MA
- ZIP
- 01757
- Country
- US
- [email protected]
- Phone
- 508 4737388 ext. 2004
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Pack, Hot Or Cold, Disposable | IMD | Class 1 | Physical Medicine | No | 2011-10-07 |
| Test, Follicle Stimulating Hormone (Fsh), Over The Counter | NGA | Class 1 | Clinical Chemistry | No | 2026-06-08 |
| Massager, Therapeutic, Manual | LYG | Class 1 | Physical Medicine | No | 2006-09-01 |
| Clinical Electronic Thermometer | SDV | Class 2 | General Hospital | No | 2025-07-07 |
| Strip, Temperature, Forehead, Liquid Crystal | KPD | Class 2 | General Hospital | No | 2012-02-03 |
| Adhesive Backed Thermal Skin Patches | OMW | Class 1 | Physical Medicine | No | 2011-12-20 |
| Bandage, Elastic | FQM | Class 1 | General Hospital | No | 2018-04-12 |
| Pad, Menstrual, Unscented | HHD | Class 1 | Obstetrics/Gynecology | No | 2023-01-17 |
| Joint, Knee, External Brace | ITQ | Class 1 | Physical Medicine | No | 2018-04-12 |
| Toothbrush, Manual | EFW | Class 1 | Dental | No | 2005-12-12 |
| Gas Chromatography, Methamphetamine | LAF | Class 2 | Clinical Toxicology | No | 2017-04-25 |
| Enzyme Immunoassay, Cannabinoids | LDJ | Class 2 | Clinical Toxicology | No | 2017-04-25 |
| Tape And Bandage, Adhesive | KGX | Class 1 | General Hospital | No | 2026-03-02 |
| Brush, Dermabrasion, Powered | GFE | Class 1 | General, Plastic Surgery | No | 2018-04-12 |
| Hearing Aid, Air-Conduction, Over The Counter | QUF | Class 1 | Ear, Nose, Throat | No | 2025-06-17 |
| Snare, Surgical | GAE | Class 1 | General, Plastic Surgery | No | 2022-07-27 |
| First Aid Kit With Drug | LRR | Class N | Unknown | No | 2024-12-23 |
| Massager, Therapeutic, Electric | ISA | Class 1 | Physical Medicine | No | 2009-06-01 |
| Joint, Ankle, External Brace | ITW | Class 1 | Physical Medicine | No | 2018-04-12 |
| Visual, Pregnancy Hcg, Prescription Use | JHI | Class 2 | Clinical Chemistry | No | 2019-03-22 |
| Kit, Test, Pregnancy, Hcg, Over The Counter | LCX | Class 2 | Clinical Chemistry | No | 2019-03-22 |
| Applicator, Ent | KCJ | Class 1 | Ear, Nose, Throat | No | 2023-05-08 |
| Support, Arm | IOY | Class 1 | Physical Medicine | No | 2018-04-12 |
| Apparatus, Suction, Single Patient Use, Portable, Nonpowered | GCY | Class 1 | General, Plastic Surgery | No | 2025-12-04 |
| Dressing, Wound, Hydrophilic | NAC | Class 1 | General, Plastic Surgery | No | 2022-07-27 |
| Toothbrush, Ionic, Battery-Powered | MMD | Class 1 | Dental | No | 2011-12-12 |
| Floss, Dental | JES | Class 1 | Dental | No | 2005-12-12 |
| Toothbrush, Powered | JEQ | Class 1 | Dental | No | 2009-08-26 |
| Test, Luteinizing Hormone (Lh), Over The Counter | NGE | Class 1 | Clinical Chemistry | No | 2017-04-25 |
| Finger Cot | LZB | Class 1 | General Hospital | No | 2023-04-21 |
| Bag, Ice | KYR | Class 1 | General Hospital | No | 2018-04-12 |
| Ring, Teething, Non-Fluid Filled | MEF | Class 1 | Dental | No | 2022-07-26 |
| Enzyme Immunoassay, Amphetamine | DKZ | Class 2 | Clinical Toxicology | No | 2023-04-07 |
| Enzyme Immunoassay, Methadone | DJR | Class 2 | Clinical Toxicology | No | 2023-04-07 |
| Enzyme Immunoassay, Barbiturate | DIS | Class 2 | Clinical Toxicology | No | 2023-04-07 |
| Enzyme Immunoassay, Opiates | DJG | Class 2 | Clinical Toxicology | No | 2023-04-07 |
| Enzyme Immunoassay, Cocaine And Cocaine Metabolites | DIO | Class 2 | Clinical Toxicology | No | 2023-04-07 |
| Enzyme Immunoassay, Phencyclidine | LCM | Class U | Unknown | No | 2023-04-07 |
| Enzyme Immunoassay, Benzodiazepine | JXM | Class 2 | Clinical Toxicology | No | 2023-04-07 |
| Continuous Measurement Thermometer | FLL | Class 2 | General Hospital | No | 2017-07-14 |
| Adaptor, Grooming | ILW | Class 1 | Physical Medicine | No | 2022-07-27 |
| First Aid Kit Without Drug | OHO | Class 1 | General, Plastic Surgery | No | 2024-12-23 |
| Protector, Hearing (Insert) | EWD | Class U | Unknown | No | 2022-07-28 |
| Tampon, Menstrual, Unscented | HEB | Class 2 | Obstetrics/Gynecology | No | 2025-03-04 |
| Pack, Hot Or Cold, Reusable | IME | Class 1 | Physical Medicine | No | 2011-12-20 |
| Reader, Bar, Ophthalmic | HJY | Class 1 | Ophthalmic | No | 2021-05-18 |
Proprietary Names
COLD / HOT PAD
MASSAGER
STRIP
Cool Bandage
Cool Patch
Renewed Energy
TOOTHBRUSH
Assured
TheraPlus
Magnifier
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device