FDA.reportPublic FDA data

Accora Allevia Comfort

Primary DI
05056147701503
Brand
Accora Allevia Comfort
Company
ACCORA LIMITED
Model
Allevia Comfort
Catalog number
ACC400-0-FM1-200
Device description
"Accora, Allevia Comfort (previously Accora 400) 36""x84"" Pressure Redistribution Foam Mattress ACC400-0-FM1-200 "
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
05056147701503PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05056147701503050561477015035056147701503

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
Lot or batch
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
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
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
05056147701510Accora Allevia ComfortACCORA LIMITEDIKY2025-09-30
05056147701527Accora Allevia ComfortACCORA LIMITEDIKY2025-09-30
05056147701534Accora Allevia PrimaACCORA 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