FDA.reportPublic FDA data

Ergozone 3000

Primary DI
08592654851067
Brand
Ergozone 3000
Company
L I N E T spol. s r.o.
Model
EZ3-SEN
Device description
The passive mattres is the foam mattress intended for medical bed.
Published
2025-11-03
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
08592654851067PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08592654851067085926548510678592654851067

GMDN Terms#

Term, Definition table
TermDefinition
Basic bed mattressA large, durable, fabric case filled with a resilient material designed to be placed on a bed mattress support platform to provide a comfortable surface on which an occupant can lie and rest/sleep. The device provides no special therapeutic effect.

Regulatory Flags#

DUNS number
644544504
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08592654611951Sprint 1001ES105408-10602026-07-17
08592654617656Sprint 2001ES200-7372026-07-17
08592654618554Sprint 4001ES401-162026-07-17
08592654620359Eleganza 51GE512055-26782026-07-17
08592654621530Sprint 4001ES400-832026-07-17
08592654621752Eleganza 51GE512055-30662026-07-17
08592654621790Multicare X1MCX12050-15092026-07-17
08592654601235Sprint 2001ES200-1702026-05-11
08592654577462Eleganza 51GE512055-28372026-02-26
08592654578445Sprint 4001ES410-282026-02-26
08592654582992Eleganza 51GE512055-25972026-02-26
08592654544112OPTICARE1VSM-52026-01-07
08592654554524Sprint 1001ES105308-9742026-01-07
08592654562703Multicare X1MCX12050-9372026-01-07
08592654569405Eleganza 51GE512055-25952026-01-07
08592654550441Multicare1MC17350-23922025-12-22
08592654552889Eleganza 51GE512055-26772025-12-22
08592654556184Sprint 2001ES410-32025-12-22
08592654851074Ergozone 3000EZ3-SENXL2025-11-03
08592654851081Ergozone 3000EZ3-SXXL 2025-11-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00670482001101oneNEST SUmano Medical IncIKY2026-07-31
00670482001118oneNEST SUmano Medical IncIKY2026-07-31
H93383478Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.IKY2026-07-13
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
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
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