HYPER-BOX TOPICAL WOUND OXYGEN SYSTEM
AOTI LTD.
AOTI LTD.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3006538358 | 3006538358 | AOTI LTD. | 1 | N | 2026-01-01 | Unit 20 Glenrock Business Park Ballybane GALWAY IE -- |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 68109 | 1510971189 | K920948 | TOPICAL SACRAL HYPERBARIC OXYGEN CHAMBER | KPJ | 1992-08-11 |
| 68109 | 1282001534 | K162610 | NEXA Negative Pressure Wound Therapy System | OMP | 2017-06-08 |
| 68109 | 1373448659 | K080966 | HYPER-BOX TOPICAL WOUND OXYGEN SYSTEM | KPJ | 2008-08-06 |
Product Codes Associated With Registrations#
PMN#
GUDID#
Hyperbox System - The Hyper-Box Homecare System is intended to be used for the treatment of acute and chronic wounds, such as;o skin ulcerations due to diabetes, venous stasis, post surgical infections and gangrenous lesionso decubitus ulcerso amputations/infected stumpso skin graftso burnso frostbiteThe device can be used in hospitals, nursing homes, clinics, as well as at the patient's home as an adjunct to standard wound therapy.
2017-07-05
Hyperbox System - The Hyper-Box Topical Wound Oxygen System is intended to be used for the treatment of acute and chronic wounds, such as;o skin ulcerations due to diabetes, venous stasis, post surgical infections and gangrenous lesionso decubitus ulcerso amputations/infected stumpso skin graftso burnso frostbiteThe Hyper-Box Topical Wound Oxygen controller regulates the oxygen pressure and the duration of treatment inside the extremity chamber in accordance with the physician’s orders.
2017-07-17
Hyperbox System - The Hyper-Box Homecare System is intended to be used for the treatment of acute and chronic wounds, such as; o skin ulcerations due to diabetes, venou
2017-07-05
Hyperbox System - The Hyper-Box Topical Wound Oxygen System is intended to be used for the treatment of acute and chronic wounds, such as; o skin ulcerations due to dia
2017-07-17