Aoti , Ltd.
Ireland IE-MF-000025075 Last updated 22 Oct 2026
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- Devices
- 19
- Registries
- EUDAMEDGUDIDFDA 510(k)
- FDA recalls
- 0
Catalogue
Topical Wound Oxygen Multi-Patch Multi-Patch Kit Ref Multi-Patch Kit
Topical Wound Oxygen Multi-Patch Multi-Patch Small Kit Ref Multi-Patch Small Kit
Topical Wound Oxygen Multi-Patch Multi-Patch Surgical Small Kit Ref Multi-Patch Surgical Small Kit
Topical Wound Oxygen Multi-Patch Multi-Patch Surgical Kit Ref Multi-Patch Surgical Kit
Hyperbox System, 115VAC Ref Hyperbox System, 115VAC
Hyperbox System Hyperbox Homecare System Ref Hyperbox Homecare System
Hyper-Box System, Finland Ref G00001-2-FIN
Hyper-Box Topical Wound Oxygen System Ref K080966
Hyper-Box System, Greece Ref G00001-2-GRC
Hyper-Box System, Cyprus Ref G00001-2-CYP
Hyper-Box System, Netherlands Ref G00001-2-NLD
Hyper-Box System, Germany Ref G00001-2-DEU
Hyper-Box System, Italy Ref G00001-2-ITA
Hyper-Box System, Sweden Ref G00001-2-SWE
Hyper-Box System, Belgium Ref G00001-2-BEL
Hyper-Box System, Austria Ref G00001-2-AUT
Hyper-Box System, Spain Ref G00001-2-ESP
Hyper-Box System, Switzerland Ref G00001-2-CHE
Hyper-Box System, Portugal Ref G00001-2-PRT
Hyper-Box System, Luxembourg Ref G00001-2-LUX
What Aoti , Ltd. makes
Aoti, Ltd. manufactures powered hyperbaric chambers designed for extremity oxygenation, including the Hyperbox System and the HYPER-BOX TOPICAL WOUND OXYGEN SYSTEM. These devices are intended for controlled oxygen therapy in specific medical applications.
The company’s products are classified as Class II devices under FDA regulations and are listed in the FDA’s 510(k) and UDI registries. The manufacturer is based in the United States.
Frequently asked questions
What types of medical devices does Aoti, Ltd. manufacture?
Aoti, Ltd. specializes in powered hyperbaric chambers focused on extremity oxygenation. Their primary product line includes systems like the Hyperbox System and the HYPER-BOX TOPICAL WOUND OXYGEN SYSTEM, which are designed for controlled oxygen therapy in targeted medical applications.
Where is Aoti, Ltd. based, and what does that mean for its regulatory oversight?
Aoti, Ltd. is based in the United States, which means its devices fall under FDA jurisdiction. The company’s products are subject to U.S. regulatory requirements, including classification and registration in relevant FDA databases.
How are Aoti, Ltd.’s devices classified under FDA regulations, and why does this matter?
Aoti, Ltd.’s devices are classified as Class II under FDA regulations. This classification indicates a moderate level of control is required to ensure their safety and effectiveness, typically involving pre-market submissions like the 510(k) pathway for demonstrating substantial equivalence to existing devices.
Which regulatory registries list Aoti, Ltd.’s devices, and what information can be found there?
Aoti, Ltd.’s devices are listed in the FDA’s 510(k) registry, which documents pre-market submissions for Class II devices, and the FDA’s Unique Device Identifier (UDI) system, which standardizes device identification for tracking and traceability in the healthcare supply chain.
Information
- Country
- Ireland
- Address
- Unit 20 Glenrock Business Park, Galway, Ireland
- Website
- www.aotinc.net
- [email protected]
- Phone
- +353872355402
- PRRC contact
- Robbie Walsh
- EUDAMED SRN
- IE-MF-000025075