Data / Medical devices / Taiwan / Wellell Inc.
Wellell Inc.: FDA-registered device maker in New Taipei City, Taiwan, 10 510(k) clearances
Wellell Inc. is registered with the FDA (registration 8043439) in New Taipei City, Taiwan. It lists 7 device types. The FDA files 10 510(k) clearances under its listings, the newest dated October 28, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 8043439
- FEI number
- 3004411059
- Address
- No. 9, MIN SHENG ST., TU-CHENG, New Taipei City, Taiwan, 236044
- 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 |
|---|---|---|---|---|
| Bed, Flotation Therapy, Powered | IOQ | 2 | Contract manufacturer | accessdata.fda.gov |
| Cushion, Flotation | KIC | 1 | Manufacturer | accessdata.fda.gov |
| Humidifier, Respiratory Gas, (Direct Patient Interface) | BTT | 2 | Manufacturer | accessdata.fda.gov |
| Mattress, Air Flotation, Alternating Pressure | FNM | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Nebulizer (Direct Patient Interface) | CAF | 2 | Manufacturer | accessdata.fda.gov |
| Sleeve, Limb, Compressible | JOW | 2 | Manufacturer | accessdata.fda.gov |
| Ventilator, Non-Continuous (Respirator) | BZD | 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 |
| May 23, 2025 | K243023 | WiZARD 520 Full Face Mask | BZD | Substantially Equivalent | Wellell, Inc. | accessdata.fda.gov |
| October 29, 2020 | K193206 | WiZARD 510 Nasal Mask | BZD | Substantially Equivalent | Apex Medical Corp. | accessdata.fda.gov |
| May 17, 2019 | K182394 | WiZARD 310/320 Series CPAP Mask | BZD | Substantially Equivalent | Apex Medical Corp. | accessdata.fda.gov |
| October 6, 2014 | K141522 | APEX MEDICAL CORP. ICH CPAP WITH PVA 9S-007XXX SERIES | BZD | Substantially Equivalent | Apex Medical Corp. | accessdata.fda.gov |
| June 6, 2013 | K121642 | WIZARD 230 NASAL PILOW MASK | BZD | Substantially Equivalent | Apex Medical Corp. | accessdata.fda.gov |
| December 6, 2012 | K112079 | APEX MEDICAL XT AUTO CPAP WITH COMPLIANCE IMPROVEMENT ALGORITHM 9S-005720 | BZD | Substantially Equivalent | Apex Medical Corp. | accessdata.fda.gov |
| May 6, 2011 | K103174 | APEX MEDICAL WIZARD SERIES CPAP MASK | BZD | Substantially Equivalent | Apex Medical Corp. | accessdata.fda.gov |
| December 6, 2006 | K062664 | HUMIDCARE HEATED HUMIDIFIER, MODEL 9S-004 | BTT | Substantially Equivalent | Apex Medical Corp. | accessdata.fda.gov |
| February 16, 2005 | K050104 | APEX MEDICAL MININEB & MINIPLUS | CAF | Substantially Equivalent | Apex Medical Corp. | accessdata.fda.gov |
Compare with other makers
- All makers of Ventilator, Non-Continuous (Respirator)
- All makers of Mattress, Air Flotation, Alternating Pressure
- All makers of Sleeve, Limb, Compressible
- All makers of Bed, Flotation Therapy, Powered
- All makers of Cushion, Flotation
- All makers of Nebulizer (Direct Patient Interface)
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.