FDA Registration
Active
🇨🇳 China
Guangdong Prestige Technology Co., Ltd.
Reg #: 3008841035
·
FEI: 3008841035
·
Expires 2026
Products
4
Proprietary Names
19
Establishment Types
5
Classifications
4
Registration Details
- Registration Name
- Guangdong Prestige Technology Co., Ltd.
- Registration Number
- 3008841035
- FEI Number
- 3008841035
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- No.8,Road.1,3rd Ind.District, Houjie Qiaotou, Houjie Town, Dongguan City, Guangdong Province, China
- City
- Dongguan Guangdong
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K240272
Owner / Operator
- Firm Name
- Guangdong Prestige Technology Co., Ltd.
- Operator Number
- 10043023
- Address
- No.8,Road.1,3rd Ind.District, Houjie Qiaotou, Houjie Town, Dongguan City, Guangdong Province, China
- City
- Dongguan
- State
- Guangdong
- Postal Code
- 523950
- Country
- CN
- Correspondent
- Darcy Huang
US Agent
- Business Name
- SHARE INFO INC.
- Contact Name
- Clare Ho
- Address
- 3557 158th St Flushing, NY
- City
- Flushing
- State
- NY
- ZIP
- 11358
- Country
- US
- [email protected]
- Phone
- 929 4102964
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Vehicle, Motorized 3-Wheeled | INI | Class 2 | Physical Medicine | No | 2024-07-29 |
| Wheelchair, Powered | ITI | Class 2 | Physical Medicine | No | 2021-11-29 |
| Thermometer Kit | PXH | Class 2 | General Hospital | No | 2020-04-20 |
| Continuous Measurement Thermometer | FLL | Class 2 | General Hospital | No | 2021-11-29 |
Proprietary Names
Electric Scooter (M2085, S2091)
Electric wheelchair, Models: S7204, S7205
MOBIE(S2041), S2043, S2061, S3021
Solax Powered Wheelchair, Model: S7101, S7103
Electric Scooter (Model: S3312)
Infrared Thermometer, model STM-20
Solax Powered Wheelchair, model: S7102
Electric Scooter (Model: M2020)
Electric Wheelchair (Model: S7110)
Solax Electric Scooter (Model: S302121, S302131, S302141, S302151, S302431G, S3031)
Electric wheelchair (model: S7018)
Infrared Thermometer, Model STM-20
Solax Electric Scooter (Models: S3121, S312131)
Solax Electric Scooter (Models: S204311M, S204161, S204143)
ZIPPY SCOOTER
Solax Electric Scooter (Models: S3023, S3024, S3025, S3026)
Solax Electric Scooter (Model: S202261B)
Electric wheelchair, Model: S7012
Electric Scooter(Model:S202572J, S2060, M2089, S2050, S2030)
Establishment Types
Manufacture Medical Device
Repack or Relabel Medical Device
Export Device to the United States But Perform No Other Operation on Device
Foreign Private Label Distributor
Complaint File Establishment per 21 CFR 820.198