FDA.reportPublic FDA data

Accora Allevia Prima

Primary DI
05056147701534
Brand
Accora Allevia Prima
Company
ACCORA LIMITED
Model
Allevia Prima
Device description
"Accora, Allevia Prima (previously Accora 600) 36""x80"" Pressure Redistribution Foam Mattress ACC600-0-FM1-100"
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
IKYMattress, Flotation Therapy, Non-Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IKYMattress, Flotation Therapy, Non-PoweredGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05056147701534PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05056147701534050561477015345056147701534

GMDN Terms#

Term, Definition table
TermDefinition
Foam bed mattressA large, durable, fabric case filled with foam, which may be segmented/compartmentalised, designed to be placed on a bed mattress support platform to provide a comfortable surface on which an occupant can lie, rest, and sleep, and intended to distribute body weight over a large surface area typically to help relieve pressure points for comfort and improve blood circulation to prevent pressure sores. It may contain weight-distribution air cells. This is a reusable device.

Regulatory Flags#

DUNS number
736558755
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05056147701404Accora Allevia SenseAllevia Sense2025-09-30
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
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
00887761010901Stretcher SurfaceHILL-ROM, INC.IKY2026-02-19
00887761010918Stretcher SurfaceHILL-ROM, INC.IKY2026-02-19
00887761010925Stretcher SurfaceHILL-ROM, INC.IKY2026-02-19
05059441461654TherarestArjohuntleigh ABIKY2026-02-10
00810178885084ViveVIVE HEALTH LLCIKY2026-02-02
00810178885091ViveVIVE HEALTH LLCIKY2026-02-02
H93353893Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.IKY2025-12-01
08592654851067Ergozone 3000L I N E T spol. s r.o.IKY2025-11-03
08592654851074Ergozone 3000L I N E T spol. s r.o.IKY2025-11-03
08592654851081Ergozone 3000L I N E T spol. s r.o.IKY2025-11-03
00841447115175Invacare® Softform Premier Foam MattressINVACARE CORPORATIONIKY2025-10-10
00841447115182Invacare® Softform Premier Foam MattressINVACARE CORPORATIONIKY2025-10-10
00841447115199Invacare® Softform Premier Foam MattressINVACARE CORPORATIONIKY2025-10-10
00841447115205Invacare® Softform Premier Foam MattressINVACARE CORPORATIONIKY2025-10-10
05056147701497Accora Allevia ComfortACCORA LIMITEDIKY2025-09-30
05056147701503Accora Allevia ComfortACCORA LIMITEDIKY2025-09-30
05056147701510Accora Allevia ComfortACCORA LIMITEDIKY2025-09-30
05056147701527Accora Allevia ComfortACCORA LIMITEDIKY2025-09-30
05056147701541Accora Allevia PrimaACCORA LIMITEDIKY2025-09-30
05056147701558Accora Allevia PrimaACCORA LIMITEDIKY2025-09-30
05056147701565Accora Allevia PrimaACCORA LIMITEDIKY2025-09-30
05056147701572Accora Allevia ClassicACCORA LIMITEDIKY2025-09-30
05056147701589Accora Allevia ClassicACCORA LIMITEDIKY2025-09-30
05056147701596Accora Allevia ClassicACCORA LIMITEDIKY2025-09-30
05056147701602Accora Allevia ClassicACCORA LIMITEDIKY2025-09-30
H93331629Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.IKY2025-09-04
H93313584Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.IKY2025-09-04
H93335834Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.IKY2025-08-04
H93338296Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.IKY2025-08-04
00841447115151Invacare Solace MattressINVACARE CORPORATIONIKY2025-06-30