FDA.reportPublic FDA data

Hyperbox System

Primary DI
05391518749990
Brand
Hyperbox System
Company
AOTI LIMITED
Model
Hyperbox Homecare System
Catalog number
G00001-2
Device description
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.
Published
2017-07-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
KPJChamber, Oxygen, Topical, Extremity

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KPJChamber, Oxygen, Topical, ExtremityGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05391518749990PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05391518749990053915187499905391518749990

GMDN Terms#

Term, Definition table
TermDefinition
Extremity-oxygenation hyperbaric chamber, poweredA small, mains electricity (AC-powered) device intended to hermetically surround a patient's limb for the topical application of oxygen (O2) from a O2 supply, usually humidified, at a pressure slightly greater than atmospheric (e.g., 1 to 2 atm) during hyperbaric oxygen therapy (HBOT). The O2-enriched atmosphere may be raised above normal pressure by the device either continuously or intermittently. The device is typically a rigid plastic shell with electronic controls or a flexible shell connected to controls, tubing, and other accessories. It is typically used to treat skin ulcerations, decubitus ulcers, infected stumps, skin grafts, burns, and frostbite.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity5 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature14 Degrees Fahrenheit140 Degrees Fahrenheit

Regulatory Flags#

DUNS number
896654477
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05391518740027Hyperbox SystemHyperbox System, 115VACG000022017-07-17
53915187400272Hyperbox SystemHyperbox System, 115VACG000022017-07-17
53915187499900Hyperbox SystemHyperbox Homecare SystemG00001-22017-07-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05060371000356NATROX® Oxygen Wound TherapyINOTEC AMD LIMITEDKPJ2025-12-12
05060371000370NATROX® Oxygen Wound TherapyINOTEC AMD LIMITEDKPJ2025-12-12
00851404004015OxySpur® Oxygen Diffusion DressingElectrochemical Oxygen Concepts, Inc.KPJ2023-07-24
00851404004022OxySpur® Oxygen Diffusion DressingElectrochemical Oxygen Concepts, Inc.KPJ2023-07-24
00851404004039OxySpur® Oxygen Diffusion DressingElectrochemical Oxygen Concepts, Inc.KPJ2023-07-24
00851404004046OxySpur® Oxygen Diffusion DressingElectrochemical Oxygen Concepts, Inc.KPJ2023-07-24
00851404004060OxyGeni® Humidicant PackElectrochemical Oxygen Concepts, Inc.KPJ2023-07-24
00851404004077OxyGeni® Dual Port cannulaElectrochemical Oxygen Concepts, Inc.KPJ2023-07-24
00851404004084OxyGeni® Electrochemical Oxygen Concepts, Inc.KPJ2023-07-24
00851404004091OxySpur® Oxygen Diffusion DressingElectrochemical Oxygen Concepts, Inc.KPJ2023-07-24
00851404004107OxySpur® lite Oxygen Diffusion DressingElectrochemical Oxygen Concepts, Inc.KPJ2023-07-24
00851404004114OxyGeni® Oxygen Delivery Extension SetElectrochemical Oxygen Concepts, Inc.KPJ2023-07-24
00851404004121OxySpur® lite Oxygen Diffusion DressingsElectrochemical Oxygen Concepts, Inc.KPJ2023-07-24
00860010630600Numobag KitNumotech, Inc.KPJ2023-07-11
00855526003079EPIFLO®OgenixKPJ2023-06-08
00855526003086EPIFLO®OgenixKPJ2023-06-08
05060371000387NATROX® Oxygen Wound TherapyINOTEC AMD LIMITEDKPJ2022-03-08
05060371000349NATROX® Oxygen Wound TherapyINOTEC AMD LIMITEDKPJ2020-07-20
05060371000363NATROX® Oxygen Wound TherapyINOTEC AMD LIMITEDKPJ2020-07-20
05060371000288NATROX® Oxygen Wound TherapyINOTEC AMD LIMITEDKPJ2019-06-06
05060371000325NATROX® Oxygen Wound TherapyINOTEC AMD LIMITEDKPJ2019-06-06
05060371000165NATROX® Oxygen Wound TherapyINOTEC AMD LIMITEDKPJ2019-03-01
05060371000172NATROX® Oxygen Wound TherapyINOTEC AMD LIMITEDKPJ2019-03-01
05060371000202NATROX® Oxygen Wound TherapyINOTEC AMD LIMITEDKPJ2019-03-01
05060371000233NATROX® Oxygen Wound TherapyINOTEC AMD LIMITEDKPJ2019-03-01
05060371000004NATROX® Oxygen Wound TherapyINOTEC AMD LIMITEDKPJ2018-10-05
05060371000028NATROX® Oxygen Wound TherapyINOTEC AMD LIMITEDKPJ2018-10-05
05391518740027Hyperbox SystemAOTI LIMITEDKPJ2017-07-17
53915187400272Hyperbox SystemAOTI LIMITEDKPJ2017-07-17
53915187499900Hyperbox SystemAOTI LIMITEDKPJ2017-07-05