Global Fabtech Wheel Chair (Shanghai) Co., Ltd.
Registered establishment in Shanghai, China. 15 device types.
Global Fabtech Wheel Chair (Shanghai) Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Booth, Sun Tan, Armrest, Wheelchair and 13 other device types. Its earliest product listing with the FDA dates from 2008.
Registration
| Registered name | GLOBAL FABTECH WHEEL CHAIR (SHANGHAI) CO., LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3003882673 |
| FEI number | 3003882673 |
| Establishment type | Contract manufacturer, Repacker / relabeller, Manufacturer, Exporter |
Location
| City | Shanghai |
|---|---|
| Province | Shanghai |
| Address | No. 318 Tianfu Road |
| Postal code | 201615 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Accessories, Wheelchair | Class 1 | Zip’r | 2012 | 80 |
| Armrest, Wheelchair | Class 1 | Zip’r | 2012 | 29 |
| Booth, Sun Tan | Class 2 | Fiji Sun Fluorescent Tanning Unit (FIJI Sun) | 2018 | 1 |
| Components, Wheelchair | Class 1 | Zip’r | 2012 | 54 |
| Cuff, Pusher, Wheelchair | Class 1 | Zip’r | 2012 | 11 |
| Cushion, Wheelchair | Class 1 | Zip’r | 2012 | 53 |
| Device, Anti-Tip, Wheelchair | Class 1 | Zip’r | 2012 | 22 |
| Footrest, Wheelchair | Class 1 | Zip’r | 2012 | 25 |
| Holder, Crutch And Cane, Wheelchair | Class 1 | Zip’r | 2012 | 22 |
| Light, Ultraviolet, Dermatological | Class 2 | Spertilite Phototherapy Lamp | 2019 | 8 |
| Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) | Class 1 | KBD | 2020 | 384 |
| Sunlamp Products (Pre-Standard) | Class 2 | 2026 | 1 | |
| Support, Head And Trunk, Wheelchair | Class 1 | Zip’r | 2012 | 10 |
| Vehicle, Motorized 3-Wheeled | Class 2 | Zip’r4 Xtra, Zip’r4, Zip’r3 Xtra, Zip’r3 | 2010 | 41 |
| Wheelchair, Powered | Class 2 | Zip’r Mantis, Zip’r PC, Zip’r Mobility | 2008 | 62 |
Clearances
No clearance names Global Fabtech Wheel Chair (Shanghai) Co., Ltd. as applicant. 4 are held by another company and named on this establishment’s own product listings: the device is cleared under that company’s 510(k) and listed under this registration.
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K102361 | 2010-10-04 | INI | Traditional | Global Fabtech Wheelchair (Shanghai) Co., Ltd. |
| K102355 | 2010-10-04 | ITI | Traditional | Global Fabtech Wheelchair (Shanghai) Co., Ltd. |
| K102358 | 2010-10-04 | INI | Traditional | Global Fabtech Wheelchair (Shanghai) Co., Ltd. |
| K072224 | 2007-09-21 | ITI | Traditional | Global Fabtech Wheelchair (Shanghai) Co., Ltd. |
From the Company
Published by the company on its own website, not by the FDA.
| Main products | Power wheelchairs, Mobility scooters, Medical mobility products |
|---|---|
| OEM and ODM | Offered |
Nearby Manufacturers
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
The manufacturer named here can complete this record.