FDA.reportPublic FDA data

Accora Allevia Comfort

Primary DI
05056147701510
Brand
Accora Allevia Comfort
Company
ACCORA LIMITED
Model
Allevia Comfort
Catalog number
ACC400-0-FM2-100
Device description
"Accora, Allevia Comfort (previously Accora 400) 42""x80"" Pressure Redistribution Foam Mattress ACC400-0-FM2-100 "
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
05056147701510PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05056147701510050561477015105056147701510

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
05056147701503Accora Allevia ComfortAllevia ComfortACC400-0-FM1-2002025-09-30
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
00810055884414MATT 35X80 DELUXE STR ZIP COV CAJOERNS HEALTHCARE, LLCIKY2026-08-16
00810055884421MATT 35X80 ELITE 500-G LBS STR ZIP COV CJOERNS HEALTHCARE, LLCIKY2026-08-16
0081005588443835X80 ELITE-G 500 STR ZIP COV INC BAR,CAJOERNS HEALTHCARE, LLCIKY2026-08-16
00810055884445MATT 35X76 DELUXE STR ZIP COV CAJOERNS HEALTHCARE, LLCIKY2026-08-16
00810055884452MATT 42X80 DELUXE STR ZIP COV CAJOERNS HEALTHCARE, LLCIKY2026-08-16
00810055884469MATT 42X80 ELITE-G 500 LBS STR ZIP COV CJOERNS HEALTHCARE, LLCIKY2026-08-16
00810055884476MATT 35X80 DELUXE SW STR ZIP COV CAJOERNS HEALTHCARE, LLCIKY2026-08-16
00810055884483MATT 35X80 ELITE-G SW 500 STR ZIP COV CJOERNS HEALTHCARE, LLCIKY2026-08-16
00810055884490MATT 35X80 BASIC STR ZIP COV CAJOERNS HEALTHCARE, LLCIKY2026-08-16
00810055884506MATT 35X76 ELITE-G 500 LBS STR ZIP COV CJOERNS HEALTHCARE, LLCIKY2026-08-16
00810055884513MATT 35X84 DELUXE STR ZIP COV CAJOERNS HEALTHCARE, LLCIKY2026-08-16
0081005588452035X84 ELITE-G 500 STR ZIP COV INC BAR,CAJOERNS HEALTHCARE, LLCIKY2026-08-16
00810055884537MATT 42X80 ELITE-G 600 LBS STR ZIP COV CJOERNS HEALTHCARE, LLCIKY2026-08-16
00810055884544MATT 35X76 DELUXE SW STR ZIP COV CAJOERNS HEALTHCARE, LLCIKY2026-08-16
00810055884551MATT 36X80 DELUXE STR ZIP COV CAJOERNS HEALTHCARE, LLCIKY2026-08-16
00810055884568MATT 36X80 ELITE-G 500 LBS STR ZIP COV CJOERNS HEALTHCARE, LLCIKY2026-08-16
00810055884575MATT 35X80 ELITE-G 600 LBS STR ZIP COV CJOERNS HEALTHCARE, LLCIKY2026-08-16
00810055884582MATT 35X76 ELITE-G SW 500 STR ZIP COV CJOERNS HEALTHCARE, LLCIKY2026-08-16
00810055884599MATT 35X84 ELITE-G 500 LBS STR ZIP COV CJOERNS HEALTHCARE, LLCIKY2026-08-16
00810055884612MATT 42X80 ELITE-G SW 500 STR ZIP COV CJOERNS HEALTHCARE, LLCIKY2026-08-16
00810055884636MATT 39X80 DELUXE STR ZIP COV CAJOERNS HEALTHCARE, LLCIKY2026-08-16
00810055884643MATT 42X80 DELUXE SW STR ZIP COV CAJOERNS HEALTHCARE, LLCIKY2026-08-16
00810055884674MATT 36X80 DELUXE SW STR ZIP COV CAJOERNS HEALTHCARE, LLCIKY2026-08-16
00810055884681MATT 42X84 ELITE-G 500 LBS STR ZIP COV CJOERNS HEALTHCARE, LLCIKY2026-08-16
00810055884704MATT 42X84 DELUXE STR ZIP COV CAJOERNS HEALTHCARE, LLCIKY2026-08-16
00810055884711MATT 35X84 DELUXE SW STR ZIP COV CAJOERNS HEALTHCARE, LLCIKY2026-08-16
0081005588472836X80 ELITE-G 500 STR ZIP COV INC BAR,CAJOERNS HEALTHCARE, LLCIKY2026-08-16
00810055884735MATT 35X84 ELITE-G SW 500 STR ZIP COV CJOERNS HEALTHCARE, LLCIKY2026-08-16
00810055884742MATT 42X84 ELITE-G 600 LBS STR ZIP COV CJOERNS HEALTHCARE, LLCIKY2026-08-16
00810055884759MATT 39X80 ELITE-G 500 LBS STR ZIP COV CJOERNS HEALTHCARE, LLCIKY2026-08-16