AOK Tooling Limited
Manufacturer and brand owner in Shen Zhen, Guangdong, China. 6 device types, 1 product catalogued, 3 clearances.
AOK Tooling Limited is a contract manufacturer holding a current FDA establishment registration. The registration covers Mask, Surgical, Respirator, Surgical and 4 other device types. 1 of its products is catalogued under its own name. Its earliest product listing with the FDA dates from 2008.
6device types registered with the FDA
1product
3510(k) clearances
Registration
| Status | Registered |
|---|---|
| Registration expires | 2026 |
| Registration number | 3006897516 |
| FEI number | 3006897516 |
| DUNS | 544325948 |
| Establishment type | Contract manufacturer, Private-label distributor, Complaint-file establishment, Manufacturer, Exporter |
Chinese Registration
| Chinese legal name | 飛速工業有限公司 |
|---|---|
| Source | Hong Kong company register lookup |
Location
| City | Shen Zhen |
|---|---|
| Province | Guangdong |
| Address | 101 and 1Building, 2Building, 3Building, 4Building, 5Building, |
| Postal code | 518122 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Apparatus, Nitric Oxide Delivery | Class 2 | NOxFLOW sensor for use with NOxBOXi system | 2023 | 1 |
| Circuit, Breathing (W Connector, Adaptor, Y Piece) | Class 1 | CSC300, Neo-Verso Y | 2009 | 55 |
| Connector, Airway (Extension) | Class 1 | Hi-Ox Mask Aerosol Adapter | 2013 | 20 |
| Mask, Surgical | Class 2 | AOK 95A Medical Mask (20200049), 039 Medical Surgical Face Mask (20190039), Plain Surgical Face Mask (20190019) | 2020 | 125 |
| Respirator, Surgical | Class 2 | Professional Respirator 3D N95 (20160001), Professional Respirator 3D N95 OR (20100032), M. Mask (20180021-L), Professional Respirator 3D N95 B (20180022), VFold Professional Respirator N95 B (20180016), VFold Professional Respirator N95 (20170001) and 2 more | 2019 | 118 |
| Set, Tubing And Support, Ventilator (W Harness) | Class 1 | Set Tubing and Support Ventilator | 2008 | 33 |
Own-Brand Listings
| Product | Code | Catalogue numbers |
|---|---|---|
| AOK | FXX | 31 |
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K220876 | 2022-07-27 | FXX | Traditional | This company |
| K211956 | 2021-11-23 | FXX | Traditional | This company |
| K201517 | 2020-09-04 | FXX | Traditional | This company |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 1986 |
|---|---|
| Employees | 100+ |
| Factory area | 5850 sqm (63000 sq ft) |
| Main products | Tooling design and fabrication, Die making, Mold making, High-quality parts manufacturing |
| Export markets | Europe and USA |
Nearby Manufacturers
| Manufacturer | Device types |
|---|---|
| Shen FU Arts LAB | 15 |
| Shenzhen Joose Beauty Electronic Co., Ltd. | 13 |
| Shenzhen BSX Technology Electronics Co., Ltd. | 5 |
| SKG Health Technologies Co., Ltd. | 5 |
| Fran Wheel Enterprise Co., Ltd. | 4 |
| Shenzhenshi Hengmeite Technology Co., Ltd. | 4 |
| Shenzhen Kingyield Technology Co., Ltd. | 3 |
| Shenzhen Increcare Biotech Co., Ltd. | 1 |
| Tsuen LEE Metals & Plastic Toys Factory | 1 |
| Shenzhen Xiaobaimaijia Networktechnology Co., Ltd. | 1 |
| Chuan YI QI Tech Shen Zhen Co., Ltd. | 1 |
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.