FDA.reportPublic FDA data

Accora Allevia Sense

Primary DI
05056147701404
Brand
Accora Allevia Sense
Company
ACCORA LIMITED
Model
Allevia Sense
Device description
Accora, Alternating-pressure bed mattress system including Air Pump PUMP-0-AM3-000US supplied with Allevia Sense Air Mattresses AIRMAT-0-AM4-000 or AIRMAT-0-AM4-100
Published
2025-09-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
FNMMattress, Air Flotation, Alternating Pressure

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FNMMattress, Air Flotation, Alternating PressureGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05056147701404PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05056147701404050561477014045056147701404

GMDN Terms#

Term, Definition table
TermDefinition
Alternating-pressure bed mattress systemAn assembly of devices consisting of an alternating-pressure bed mattress (inflation-patterned air cells with or without foam component) and a dedicated electric pump, which also functions as the control unit, designed to actively alternate a bed occupant's bed-contact points, typically to relieve pressure points for comfort and to prevent pressure sores. It is commonly used for elderly immobilized (especially in cases of decubitus ulcers), patients with disabilities, or patients with low body fat.

Regulatory Flags#

DUNS number
736558755
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05056147701428Accora Allevia DuoAllevia DuoPUMP-0-AF1-8002025-09-30
05056147701435Accora Allevia DuoAllevia DuoACC800-0-AF1-1002025-09-30
05056147701442Accora Allevia DuoAllevia DuoACC800-0-AF1-2002025-09-30
05056147701459Accora Allevia DuoAllevia DuoACC800-0-AF2-1002025-09-30
05056147701466Accora Allevia DuoAllevia DuoACC800-0-AF2-2002025-09-30
05056147701497Accora Allevia ComfortAllevia ComfortACC400-0-FM1-1002025-09-30
05056147701503Accora Allevia ComfortAllevia ComfortACC400-0-FM1-2002025-09-30
05056147701510Accora Allevia ComfortAllevia ComfortACC400-0-FM2-1002025-09-30
05056147701527Accora Allevia ComfortAllevia ComfortACC400-0-FM2-2002025-09-30
05056147701534Accora Allevia PrimaAllevia Prima2025-09-30
05056147701541Accora Allevia PrimaAllevia Prima2025-09-30
05056147701558Accora Allevia PrimaAllevia Prima2025-09-30
05056147701565Accora Allevia PrimaAllevia Prima2025-09-30
05056147701572Accora Allevia ClassicAllevia Classic2025-09-30
05056147701589Accora Allevia ClassicAllevia Classic2025-09-30
05056147701596Accora Allevia ClassicAllevia Classic2025-09-30
05056147701602Accora Allevia ClassicAllevia Classic2025-09-30
05056147700162Accora FloorBed 6 Lifting PoleFloorBed 6 Lifting PoleLIFOL-0-FL6-0002021-02-01
05056147701084Accora FloorBedAlessoKWNSB-0-FL8-000US2024-09-25
05056147701091Accora FloorBedAlesso WideKWNSB-W-FL8-000US2024-09-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
H93338036Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.FNM2026-04-13
H93338042Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.FNM2026-04-13
H93338436Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.FNM2026-04-13
H93338442Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.FNM2026-04-13
H9336200Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.FNM2026-04-13
H933PR13051Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.FNM2025-12-01
00810055884230ProCair PlusJOERNS HEALTHCARE, LLCFNM2024-12-16
00810055884247ProCair PlusJOERNS HEALTHCARE, LLCFNM2024-12-16
00810055884254ProCair PlusJOERNS HEALTHCARE, LLCFNM2024-12-16
00810055884261ProCair PlusJOERNS HEALTHCARE, LLCFNM2024-12-16
00810055884278ProMatt PlusJOERNS HEALTHCARE, LLCFNM2024-12-16
00810055884285ProMatt PlusJOERNS HEALTHCARE, LLCFNM2024-12-16
00810055884292ProMatt PlusJOERNS HEALTHCARE, LLCFNM2024-12-16
00810055884308ProMatt PlusJOERNS HEALTHCARE, LLCFNM2024-12-16
00810055884315ProMatt PlusJOERNS HEALTHCARE, LLCFNM2024-12-16
00810055884322ProMatt PlusJOERNS HEALTHCARE, LLCFNM2024-12-16
00810055884339ProMatt PlusJOERNS HEALTHCARE, LLCFNM2024-12-16
00810055884346ProMatt PlusJOERNS HEALTHCARE, LLCFNM2024-12-16
00810055884353ProMatt PlusJOERNS HEALTHCARE, LLCFNM2024-12-16
00810055884360ProMatt PlusJOERNS HEALTHCARE, LLCFNM2024-12-16
00023601033093CAREX HEALTH BRANDSDrive Devilbiss HealthcareFNM2024-06-13
H93365077Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.FNM2024-04-16
H93364565Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.FNM2024-02-14
00190885000049MatrixMidtown Investments, LLCFNM2023-01-28
00190885000056MatrixMidtown Investments, LLCFNM2023-01-28
00190885000063MatrixMidtown Investments, LLCFNM2023-01-28
00190885000070MatrixMidtown Investments, LLCFNM2023-01-28
00190885000087MatrixMidtown Investments, LLCFNM2023-01-28
00190885000094MatrixMidtown Investments, LLCFNM2023-01-28
00190885000100MatrixMidtown Investments, LLCFNM2023-01-28