Apex Medical (Kunshan) Corp.
Registered establishment in Kunshan, Jiangsu, China. 4 device types.
Apex Medical (Kunshan) Corp. is a contract manufacturer holding a current FDA establishment registration. The registration covers Cushion, Flotation, Sleeve, Limb, Compressible and 2 other device types. Its earliest product listing with the FDA dates from 1994.
Registration
| Status | Registered |
|---|---|
| Registration expires | 2026 |
| Registration number | 3006339858 |
| FEI number | 3006339858 |
| Establishment type | Contract manufacturer, Manufacturer |
Location
| City | Kunshan |
|---|---|
| Province | Jiangsu |
| Address | No.1368, Zi Zhu Rd. |
| Postal code | 215316 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Cushion, Flotation | Class 1 | Procare Auto G3 Seat cushion | 2025 | 52 |
| Mattress, Air Flotation, Alternating Pressure | Class 2 | ACS Series Pump and Mattress, Serene Bariatric, Sedens 500, SERENE Series Pump and Mattress, Optima Turn, Optima Auto and 25 more | 1994 | 52 |
| Nebulizer (Direct Patient Interface) | Class 2 | Mini Star, Minicare | 1996 | 42 |
| Sleeve, Limb, Compressible | Class 2 | VenAir, Sequential Compression System | 2025 | 24 |
Clearances
No clearance names Apex Medical (Kunshan) Corp. as applicant. One is 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 |
|---|---|---|---|---|
| K251466 | 2025-10-28 | JOW | Special | Wellell Inc. |
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.