FDA Registration
Active
🇨🇳 China
GLOBAL FABTECH WHEEL CHAIR (SHANGHAI) CO., LTD.
Reg #: 3003882673
·
FEI: 3003882673
·
Expires 2026
Products
15
Proprietary Names
11
Establishment Types
4
Classifications
15
Registration Details
- Registration Name
- GLOBAL FABTECH WHEEL CHAIR (SHANGHAI) CO., LTD.
- Registration Number
- 3003882673
- FEI Number
- 3003882673
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- No. 318 Tianfu Road, JIUTING, SONGJIANG
- City
- SHANGHAI
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K102355
Owner / Operator
- Firm Name
- GLOBAL FABTECH WHEEL CHAIR (SHANGHAI) CO., LTD.
- Operator Number
- 9043991
- Address
- NO. 318 TIANFU ROAD, JIUTING, SONGJIANG
- City
- SHANGHAI
- State
- CN-NOTA
- Postal Code
- 201615
- Country
- CN
- Correspondent
- THOMAS - TAN
US Agent
- Business Name
- USA
- Contact Name
- Zachary Tan
- Address
- 44047 SE Tanner Road, Suite C
- City
- North Bend
- State
- WA
- ZIP
- 98045
- Country
- US
- [email protected]
- Phone
- 425 6541097
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Device, Anti-Tip, Wheelchair | IMR | Class 1 | Physical Medicine | No | 2012-09-10 |
| Wheelchair, Powered | ITI | Class 2 | Physical Medicine | No | 2011-03-01 |
| Cushion, Wheelchair | IMP | Class 1 | Physical Medicine | No | 2012-09-10 |
| Support, Head And Trunk, Wheelchair | IMS | Class 1 | Physical Medicine | No | 2012-09-10 |
| Booth, Sun Tan | LEJ | Class 2 | General, Plastic Surgery | No | 2018-12-21 |
| Vehicle, Motorized 3-Wheeled | INI | Class 2 | Physical Medicine | No | 2010-11-08 |
| Armrest, Wheelchair | IML | Class 1 | Physical Medicine | No | 2012-09-10 |
| Components, Wheelchair | KNN | Class 1 | Physical Medicine | No | 2012-09-10 |
| Cuff, Pusher, Wheelchair | INC | Class 1 | Physical Medicine | No | 2012-09-10 |
| Sunlamp Products (Pre-Standard) | RAB | Class 2 | General, Plastic Surgery | No | 2026-04-23 |
| Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) | HOY | Class 1 | Ophthalmic | No | 2020-08-17 |
| Holder, Crutch And Cane, Wheelchair | IMZ | Class 1 | Physical Medicine | No | 2012-09-10 |
| Accessories, Wheelchair | KNO | Class 1 | Physical Medicine | No | 2012-09-10 |
| Light, Ultraviolet, Dermatological | FTC | Class 2 | General, Plastic Surgery | No | 2019-11-07 |
| Footrest, Wheelchair | IMM | Class 1 | Physical Medicine | No | 2012-09-10 |
Proprietary Names
Zip'r
Zip'r Mantis
Fiji Sun Fluorescent Tanning Unit (FIJI Sun)
Zip'r3 Xtra
Zip'r3
Zip'r PC
Zip'r Mobility
Zip'r4 Xtra
Zip'r4
KBD
Spertilite Phototherapy Lamp
Establishment Types
Manufacture Medical Device
Export Device to the United States But Perform No Other Operation on Device
Repack or Relabel Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)