Zhongshan A&J Medical Equipment Co., Ltd.
Registered establishment in Guangdong, China. 7 device types, 4 clearances.
Zhongshan A&J Medical Equipment Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Walker, Mechanical, Chair, With Casters and 5 other device types. Its earliest product listing with the FDA dates from 2002.
Registration
| Registered name | ZHONGSHAN A&J MEDICAL EQUIPMENT CO., LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3004443928 |
| FEI number | 3004443928 |
| Establishment type | Manufacturer |
Chinese Registration
| Chinese legal name | 中山荣杰医疗器材工业有限公司 |
|---|---|
| Source | export sales certificate, Guangdong medical products administration |
Location
| City | Guangdong |
|---|---|
| Province | Guangdong |
| Address | 3 SHENGHUI SOUTH ROAD |
| Postal code | — |
| Country | China |
Group
Zhongshan A&J Medical Equipment Co., Ltd. is one of 2 plants registered under TAIWAN AN I CO.,LTD..
| Plant | City | Device types |
|---|---|---|
| A & I Industries Ltd | Foshan | 35 |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Chair, With Casters | Class 1 | Hugo, Airgo, Trust Worth, Transport chair, Guardian, Drive and 6 more | 2004 | 85 |
| Nebulizer (Direct Patient Interface) | Class 2 | John Bunn | 2014 | 42 |
| Pump, Portable, Aspiration (Manual Or Powered) | Class 2 | John Bunn, Guardian, Medline, Drive, Rhythm | 2007 | 14 |
| Splint, Extremity, Non-Inflatable, External, Non-Sterile | Class 1 | Padded Splint, Waterproof Splint, Disposable Splint, Drive, Ferno 444 Traction Splint, Medline and 2 more | 2011 | 62 |
| Stretcher, Hand-Carried | Class 1 | Titan, Gazelle, Ferno 65 Scoop | 2012 | 51 |
| Walker, Mechanical | Class 1 | Gavo 2 in 1, Hugo, Alevo, Knee Walker, Medline, Drive and 12 more | 2002 | 183 |
| Wheelchair, Powered | Class 2 | Sparky, Fusion, Guardian, drive TM, Medline, Everest Jennings and 2 more | 2007 | 62 |
Clearances
4 clearances name Zhongshan A&J Medical Equipment Co., Ltd. as applicant. 2 are held by other companies 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 |
|---|---|---|---|---|
| K253340 | 2026-04-03 | ITI | Traditional | This company |
| K121531 | 2012-07-17 | CAW | Traditional | This company |
| K071608 | 2008-01-11 | CAW | Traditional | This company |
| K071607 | 2007-06-26 | BTA | Traditional | This company |
| K052811 | 2005-12-21 | CAF | Traditional | Hsiner Co., Ltd. |
| K041190 | 2004-05-25 | ITI | Traditional | Well Success Biotech, Inc. |
Nearby Manufacturers
| Manufacturer | Device types |
|---|---|
| Yahorng Dongguan Electronic Co Ltd | 8 |
| KAI Xing Optical Limited | 4 |
| Mastars Industries Co., Ltd. | 3 |
| Jetcrown Industrial (Dong Guan) Ltd. | 3 |
| Shantou City KIN Seng Plastic Co., Ltd. | 3 |
| Guangzhou Usom Glasses Co., Ltd. | 2 |
| Mentholatum (China) Pharmaceuticals Co., Ltd. | 1 |
| Dongguan Motormillions Industries 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.