Data / Medical devices / Ireland / Aoti Ltd.
Aoti Ltd.: FDA-registered device maker in GALWAY Galway(County), Ireland, 3 510(k) clearances
Aoti Ltd. is registered with the FDA (registration 3006538358) in GALWAY Galway(County), Ireland. It lists 2 device types. The FDA files 3 510(k) clearances under its listings, the newest dated June 8, 2017. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3006538358
- Address
- Unit 20 Glenrock Business Park Ballybane, GALWAY Galway(County), Ireland, --
- Owner or operator
- AOTI LTD. (9099459)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- March 23, 2007
- Registered through
- 2026
- Brand names listed
- Hyper-Box System, NEXA NPWT System, Topical Wound Oxygen Multi-Patch
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Chamber, Oxygen, Topical, Extremity | KPJ | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Negative Pressure Wound Therapy Powered Suction Pump | OMP | 2 | Complaint file establishment, 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 |
|---|---|---|---|---|---|---|
| June 8, 2017 | K162610 | NEXA Negative Pressure Wound Therapy System | OMP | Substantially Equivalent | Nexa Medical , Ltd. | accessdata.fda.gov |
| August 6, 2008 | K080966 | HYPER-BOX TOPICAL WOUND OXYGEN SYSTEM | KPJ | Substantially Equivalent | Aoti , Ltd. | accessdata.fda.gov |
| August 11, 1992 | K920948 | TOPICAL SACRAL HYPERBARIC OXYGEN CHAMBER | KPJ | Substantially Equivalent | Topox Therapeuutic Rentals, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Chamber, Oxygen, Topical, Extremity
- All makers of Negative Pressure Wound Therapy Powered Suction Pump
Updated June 8, 2017. 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.