FDA Registration
Active
🇨🇳 China
Guangdong Ace-Tec Co., Ltd.
Reg #: 3008345424
·
FEI: 3008345424
·
Expires 2026
Products
6
Proprietary Names
10
Establishment Types
2
Classifications
6
Registration Details
- Registration Name
- Guangdong Ace-Tec Co., Ltd.
- Registration Number
- 3008345424
- FEI Number
- 3008345424
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- No.420, Jinxing Road, Xixi Industrial Park, Liaobu Town
- City
- Dongguan Guangdong
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K252994
Owner / Operator
- Firm Name
- Guangdong Ace-Tec Co., Ltd.
- Operator Number
- 10045403
- Address
- No.420, Jinxing Road, Xixi Industrial Park, Liaobu Town
- City
- Dongguan
- State
- Guangdong
- Postal Code
- 523400
- Country
- CN
- Correspondent
- Lucy Yang
US Agent
- Business Name
- Hlongmed International Ltd.
- Contact Name
- Anny Zhao
- Address
- 1312 17th Street#692 Denver, CO 80202
- City
- Denver
- State
- CO
- ZIP
- 80202
- Country
- US
- [email protected]
- Phone
- 503 3344880
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Massager, Therapeutic, Electric | ISA | Class 1 | Physical Medicine | No | 2013-11-12 |
| Over-The-Counter Powered Light Based Laser For Acne | OLP | Class 2 | General, Plastic Surgery | No | 2025-12-11 |
| Light Based Over The Counter Wrinkle Reduction | OHS | Class 2 | General, Plastic Surgery | No | 2025-12-11 |
| Stimulator, Transcutaneous Electrical, Aesthetic Purposes | NFO | Class 2 | Neurology | No | 2025-04-10 |
| Stimulator, Muscle, Powered, For Muscle Conditioning | NGX | Class 2 | Physical Medicine | No | 2022-06-02 |
| Toothbrush, Powered | JEQ | Class 1 | Dental | No | 2020-10-27 |
Proprietary Names
SR12D Body Roller
FCB12 face brush
FBB9 Rolling Massager
FCB5 Face brush
FCD4 face brush
LED Therapy Mask (SR11CM,SR11CM1,SR11CM2,SR11CM3,SR11CM4,SR11CM5,SR11CM6,SR11CM7,SR11CM8)
ZIIP HALO
PowerDot PD-01M2 Muscle Stimulator
TCB1 electric toothbrush
TCC7, Electric toothbrush
Establishment Types
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)