Zhongshan A&E Machinery Industry Co., Ltd.
Registered establishment in Zhongshan, Guangdong, China. 25 device types.
Zhongshan A&E Machinery Industry Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Cane, Crutch and 23 other device types. Its earliest product listing with the FDA dates from 2015.
25device types registered with the FDA
2recalls
Registration
| Registered name | ZHONGSHAN A&E MACHINERY INDUSTRY CO., LTD |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3003781173 |
| FEI number | 3003781173 |
| Establishment type | Manufacturer, Exporter |
Location
| City | Zhongshan |
|---|---|
| Province | Guangdong |
| Address | No 4 and No 8 Plants 9 Shenghui South Road |
| Postal code | 510000 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Adaptor, Hygiene | Class 1 | Repl Locking CASTERS-MC000480, Repl NON-Lock CASTERS-MC000480, Replacement TIP, Shower Chair Alum W/FT RST, Mounting Plate Assembly, FT Stool ECN BLK Epxy FIN 2/CS and 13 more | 2015 | 193 |
| Aid, Transfer | Class 1 | Exten Legs 4″ FOR 7927/7929, Suction Cups Legs, Trans Bench HVY Duty 1EA, Trans Bench HVY Duty | 2015 | 118 |
| Bariatric Bed | Class 2 | Bariatric bed | 2016 | 10 |
| Bed, Ac-Powered Adjustable Hospital | Class 2 | BED Rails Lbty Quarter Rail HI, Replacement Crossbrace Sleeves, Liberty Crossbars (Beige), BED Rails Full Tele Univ Chrm, Replc Knob FOR GF6650A-1 Rails, Rail Crossbrace Knobs 6/CS and 1 more | 2015 | 95 |
| Bed, Manual | Class 1 | 2015 | 122 | |
| Cane | Class 1 | Cane Offset Silver Soft GRP, Cane Offset Black Soft GRP | 2015 | 97 |
| Cane, Safety Walk | Class 1 | 2015 | 25 | |
| Chair And Table, Medical | Class 1 | Overbed Table TLT-TOP DLX, Cstr Overbed Tble GF8905-1A | 2015 | 94 |
| Chair, Blood Donor | Class 1 | 2015 | 7 | |
| Chair, With Casters | Class 1 | 2015 | 85 | |
| Component, Traction, Non-Invasive | Class 1 | DUKAL Electric Perfect Leg Stretcher | 2018 | 18 |
| Crutch | Class 1 | Canvas 1-PIECE Sling | 2020 | 112 |
| Exerciser, Non-Measuring | Class 1 | 2015 | 82 | |
| Halter, Head, Traction | Class 1 | Traction VYL WTR WT BAG 20 LB., Traction SET Overdoor, Head Halter Universal | 2015 | 9 |
| Instrument, Manual, Surgical, General Use | Class 1 | 2015 | 110 | |
| Lift, Patient, Non-Ac-Powered | Class 1 | Canvas 1-PIECE Sling | 2020 | 71 |
| Nebulizer (Direct Patient Interface) | Class 2 | NEB-U-Tyke Igloo Display, NEB-U-Tyke NEB-A-Doodle, Repl Filter FOR NEB-A-Doodle, Reservoir Tube FOR NEB Speedst, NEB-U-Tyke IC – Penguin, Rplcmt Bumper NEB-U-Tyke Train and 15 more | 2020 | 42 |
| Pump, Portable, Aspiration (Manual Or Powered) | Class 2 | Collection Bottle FOR 800 EV2, Suction Tube FOR 800 EV2, Connection Tubing FOR 800 EV2, Aspirator Vacutec 800 EV2, Regulator Assembly FOR 800 EV2, NUT Fltr FOR Vacutec 800 EV2 and 4 more | 2020 | 14 |
| Splint, Extremity, Non-Inflatable, External, Non-Sterile | Class 1 | 2015 | 62 | |
| Stand, Infusion | Class 1 | Cstrs FOR IV POLEGF7012-1 | 2015 | 75 |
| Stool, Operating-Room | Class 1 | 2015 | 16 | |
| Tips And Pads, Cane, Crutch And Walker | Class 1 | 2015 | 69 | |
| Tray, Surgical, Instrument | Class 1 | Zhongshan A&E Machinery Industry Co., Ltd., Instrument Table Mayo Type | 2017 | 105 |
| Walker, Mechanical | Class 1 | Walker Fold Dual REL X-WD, FXD Wheel 5 W/ EXT 1 Wlkrs, Lumex Dual Release 1″ Junior, Walker Dual REL X-WD W/5 Wheel, Glide Tips, Wheels 5 FXD Bariatric Walkers and 14 more | 2015 | 183 |
| Wheelchair, Mechanical | Class 1 | Seat Uph,blk Nyln 26X18-PMT XD, ARM PAD, DSK – PMT XD, Medichoice Bari WC 26W DSK ELR, Positioning Belt – PMT XD, Arms,detach DSK – PMT XD, GRIP(10EACH) PMT XD and 20 more | 2020 | 46 |
Clearances
No clearance names Zhongshan A&E Machinery Industry Co., Ltd. as applicant. 3 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 |
|---|---|---|---|---|
| K091272 | 2009-11-10 | CAF | Traditional | Besmed Health Business Corporation |
| K071607 | 2007-06-26 | BTA | Traditional | Zhongshan A&J Medical Equipment Co., Ltd. |
| K052586 | 2005-12-09 | IOR | Traditional | Taiwan an I Co., Ltd. |
Recalls
The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2006-06-30 | Not classified | Other | Walker wheel hubs may fracture, causing walker to collapse to one side. | 32,636 units. | 2011-07-20 |
| 2006-06-30 | Not classified | Other | Walker wheel hubs may fracture, causing walker to collapse to one side. | 63,153 units. | 2011-07-20 |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2000 |
|---|---|
| Employees | 1500 |
| Factory area | 120,000 sq m |
| Main products | Carbon fiber prepreg, Carbon fiber boards, Composite materials |
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.
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