FDA.reportPublic FDA data

Span-America

Primary DI
H933EZ161896
Brand
Span-America
Company
SPAN-AMERICA MEDICAL SYSTEMS, INC.
Model
EZ-DISH
Catalog number
EZ1618-96
Device description
EZ-DISH CUSHION 16X18
Published
2026-02-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
IMPCushion, Wheelchair

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IMPCushion, WheelchairPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
H933EZ161896PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Foam-filled chair cushionA foam-filled pad designed to be placed on the seat of a chair to distribute an occupant's body weight over the surface of the buttocks, typically to relieve pressure points for comfort and to prevent pressure sores. It is commonly used for elderly immobilized patients especially in cases of decubitus ulcers, patients with disabilities, or patients with low body fat. It may be used in a wheelchair and may contain weight-distribution air cells. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
073704413
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
H93352765Span-AmericaCustom Care Convertible527652026-08-25
H93363822Span-AmericaCustom Care Convertible638222026-08-25
H933SWAVE01Span-AmericaSHORT WAVESWAVE-012022-07-13
H933SWAVE04Span-AmericaSHORT WAVESWAVE-042022-07-13
H933SWAVE1601Span-AmericaSHORT WAVESWAVE16-012022-07-13
H933SWAVE1604Span-AmericaSHORT WAVESWAVE16-042022-07-13
H933SWAVE2001Span-AmericaSHORT WAVESWAVE20-012022-07-13
H933SWAVE2004Span-AmericaSHORT WAVESWAVE20-042022-07-13
H93359076Span-AmericaAPM2590762026-07-27
H93383478Span-AmericaULTRAMAX834782026-07-13
H93338036Span-AmericaAPM-i380362026-04-13
H93338042Span-AmericaAPM-i380422026-04-13
H93338436Span-AmericaAPM-i384362026-04-13
H93338442Span-AmericaAPM-i384422026-04-13
H9336200Span-AmericaAPM-i62002026-04-13
H93392270Span-AmericaSpan Care Convertible922702026-02-25
H933P11634Span-AmericaFloor LiftP116342025-12-03
H933PR13051Span-AmericaOSKA APM2PR13-0512025-12-01
H93353893Span-AmericaGEOMATTRESS 350538932025-12-01
H93332864Span-AmericaCUSTOM CARE LAL328642025-09-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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