Data / Medical devices / China / Zhongshan A&e Machinery Industry Co., Ltd
Zhongshan A&e Machinery Industry Co., Ltd: FDA-registered device maker in Zhongshan City Guangdong, China, 3 510(k) clearances
Zhongshan A&e Machinery Industry Co., Ltd is registered with the FDA (registration 3003781173) in Zhongshan City Guangdong, China. It lists 25 device types. The FDA files 3 510(k) clearances under its listings, the newest dated November 10, 2009. 1 recall event names it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3003781173
- Address
- No 4 and No 8 Plants 9 Shenghui South Road Nantou Town, Zhongshan City Guangdong, China, 510000
- Owner or operator
- Zhongshan A&E Machinery Industry Co., LTD (10049449)
- Roles
- Exporter to the US, Manufacturer
- First device listed
- June 2, 2015
- Registered through
- 2027
- Brand names listed
- 3" SWIVEL WHEELS, 4" EXTENSION LEGS, 5ESC20 ECONOMY SHOWER CHAIR, 5ESC20 ECONOMY SHWR CHR FTRST, ACCESSORY KIT (PEN,STAR,HEART), ANTI-FOLDING BAR, CHROMED (LOWER FRAME), ANTI-TIPPER PR, PARAMOUNT XD, ARM PAD, DSK - PMT XD and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| November 10, 2009 | K091272 | BESMED JET NEBULIZER BOTTLE SET | CAF | Substantially Equivalent | Besmed Health Business Corp | accessdata.fda.gov |
| June 26, 2007 | K071607 | ASA01 HEAVY DUTY SUCTION PUMP | BTA | Substantially Equivalent | Zhongshan A&J Medical Equipment Co., Ltd. | accessdata.fda.gov |
| December 9, 2005 | K052586 | A & I PEDIATRIC WHEELCHAIRS, MODELS RWAL2006-12, LT3207-12. A & I BARIATRIC WHEELCHAIRS, MODEL NO. WCDE2611P, WCDE2811P | IOR | Substantially Equivalent | Taiwan an I Co., Ltd. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| June 30, 2006 | 35786 | Not yet classified | Terminated | Guardian Walker, Models 30751W, 30757W, 30758W, Made in China by A&E Machinery Industry Co., Ltd. | Walker wheel hubs may fracture, causing walker to collapse to one side. | accessdata.fda.gov |
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Updated November 10, 2009. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.