FDA.reportPublic FDA data

Span-America

Primary DI
H933449001
Brand
Span-America
Company
SPAN-AMERICA MEDICAL SYSTEMS, INC.
Model
SPAN AIDS
Catalog number
44900-1
Device description
HEEL MANAGER 1/CS - box P11045- Uline S13328
Published
2022-07-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
KICCushion, Flotation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KICCushion, FlotationPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
H933449001PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Leg/knee cushionA soft pillow or pad intended to be placed under or between the leg(s)/knee(s) of a patient during the treatment/prevention of musculoskeletal and/or circulatory disorders. It is primarily intended for support when the patient is lying down, and may be used for one or more of the following: to reduce pressure on or between the legs, to improve postural alignment (e.g., of the spine or legs), to improve blood circulation in the lower extremities, and/or to prevent pressure sores/ulcers.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
073704413
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
H933EZ161896Span-AmericaEZ-DISHEZ1618-962026-02-26
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
H93355696Span-AmericaCUSTOM CARE LAL2025-09-09
H93384683Span-AmericaCUSTOM CARE LAL846832025-09-09
H93392474Span-AmericaCUSTOM CARE LAL924742025-09-09
H93331629Span-AmericaPlus316292025-09-04
H93313584Span-AmericaPlus135842025-09-04
H93335834Span-AmericaGEOMATTRESS358342025-08-04
H93338296Span-AmericaGEOMATTRESS382962025-08-04
H93350746CN16Span-AmericaGeomattress50746-CN162022-12-06
H93350077116Span-AmericaSpan Aids50077-1162022-12-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10197344014347MEDLINEMEDLINE INDUSTRIES, INC.KIC2026-05-08
00613732114824ROHO HIGH PROFILE Single Compartment CushionRoho, Inc.KIC2026-03-09
00613732114831ROHO HIGH PROFILE Single Compartment CushionRoho, Inc.KIC2026-03-09
00613732114848ROHO HIGH PROFILE Single Compartment CushionRoho, Inc.KIC2026-03-09
00613732114855ROHO HIGH PROFILE Single Compartment CushionRoho, Inc.KIC2026-03-09
00613732114862ROHO HIGH PROFILE Single Compartment CushionRoho, Inc.KIC2026-03-09
00613732114879ROHO HIGH PROFILE Single Compartment CushionRoho, Inc.KIC2026-03-09
00613732114886ROHO HIGH PROFILE Single Compartment CushionRoho, Inc.KIC2026-03-09
00613732114893ROHO HIGH PROFILE Single Compartment CushionRoho, Inc.KIC2026-03-09
00613732114909ROHO HIGH PROFILE Single Compartment CushionRoho, Inc.KIC2026-03-09
00613732114916ROHO HIGH PROFILE Single Compartment CushionRoho, Inc.KIC2026-03-09
00613732114923ROHO HIGH PROFILE Single Compartment CushionRoho, Inc.KIC2026-03-09
00613732114930ROHO HIGH PROFILE Single Compartment CushionRoho, Inc.KIC2026-03-09
00613732114947ROHO HIGH PROFILE Single Compartment CushionRoho, Inc.KIC2026-03-09
00613732114954ROHO HIGH PROFILE Single Compartment CushionRoho, Inc.KIC2026-03-09
00613732114961ROHO HIGH PROFILE Single Compartment CushionRoho, Inc.KIC2026-03-09
00613732114978ROHO HIGH PROFILE Single Compartment CushionRoho, Inc.KIC2026-03-09
00613732114985ROHO HIGH PROFILE Single Compartment CushionRoho, Inc.KIC2026-03-09
00613732114992ROHO LOW PROFILE Single Compartment CushionRoho, Inc.KIC2026-03-09
00613732115005ROHO LOW PROFILE Single Compartment CushionRoho, Inc.KIC2026-03-09
00613732115012ROHO LOW PROFILE Single Compartment CushionRoho, Inc.KIC2026-03-09
00613732115029ROHO LOW PROFILE Single Compartment CushionRoho, Inc.KIC2026-03-09
00613732115036ROHO LOW PROFILE Single Compartment CushionRoho, Inc.KIC2026-03-09
00613732115043ROHO LOW PROFILE Single Compartment CushionRoho, Inc.KIC2026-03-09
00613732115050ROHO LOW PROFILE Single Compartment CushionRoho, Inc.KIC2026-03-09
00613732115067ROHO LOW PROFILE Single Compartment CushionRoho, Inc.KIC2026-03-09
00613732115074ROHO LOW PROFILE Single Compartment CushionRoho, Inc.KIC2026-03-09
00613732115081ROHO LOW PROFILE Single Compartment CushionRoho, Inc.KIC2026-03-09
00613732115098ROHO LOW PROFILE Single Compartment CushionRoho, Inc.KIC2026-03-09
00613732115104ROHO LOW PROFILE Single Compartment CushionRoho, Inc.KIC2026-03-09