Data / Medical devices / China / Apex Medical (Kunshan) Corp.
Apex Medical (Kunshan) Corp.: FDA-registered device maker in Kunshan City Jiangsu, China, 1 510(k) clearance
Apex Medical (Kunshan) Corp. is registered with the FDA (registration 3006339858) in Kunshan City Jiangsu, China. It lists 4 device types. The FDA files 1 510(k) clearance under its listings, the newest dated October 28, 2025. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3006339858
- Address
- No.1368, Zi Zhu Rd. Kunshan Kai Fa Hi-Tech, Kunshan City Jiangsu, China, 215316
- Owner or operator
- Wellell Inc. (9001426)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- September 21, 1994
- Registered through
- 2026
- Brand names listed
- ACS Series Pump and Mattress, CR240, Crossover Nio, DOMUS 1 Pump and Mattress, DOMUS 2S Pump and Mattress, DOMUS 3 Pump and Mattress, DOMUS 4 Pump and Mattress, DOMUS Auto Pump and Mattress and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Cushion, Flotation | KIC | 1 | Manufacturer | accessdata.fda.gov |
| Mattress, Air Flotation, Alternating Pressure | FNM | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Nebulizer (Direct Patient Interface) | CAF | 2 | Contract manufacturer | accessdata.fda.gov |
| Sleeve, Limb, Compressible | JOW | 2 | Manufacturer | accessdata.fda.gov |
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 |
|---|---|---|---|---|---|---|
| October 28, 2025 | K251466 | VenAir, Sequential Compression System (9P-089000); VenAir, Sequential Compression System (PM01D01 / Calf garment (S)); VenAir, Sequential Compression System (PM01E01 / Calf garment (M)); VenAir, Sequential Compression System (PM01F01 / Calf garment (L)); VenAir, Sequential Compression System (PM01G01 / Thigh garment (S)); VenAir, Sequential Compression System (PM01H01 / Thigh garment (M)); VenAir, Sequential Compression System (PM01I01 / Thigh garment (L)); VenAir, Sequential Compr | JOW | Substantially Equivalent | Wellell, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Mattress, Air Flotation, Alternating Pressure
- All makers of Nebulizer (Direct Patient Interface)
- All makers of Sleeve, Limb, Compressible
- All makers of Cushion, Flotation
Updated October 28, 2025. 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.