FDA.reportPublic FDA data

Span-America

Primary DI
H933SP190000
Brand
Span-America
Company
SPAN-AMERICA MEDICAL SYSTEMS, INC.
Model
Span Aids
Catalog number
SP190-000
Device description
ELBOW PROTECTOR PAIRS
Published
2022-12-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

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
H933SP190000PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Arm friction/impact protectorA device designed to be worn over some length of the arm (various ranges from the base of the fingers to above the elbow) to provide a cover and/or cushion to protect the limb and its skin from friction and knocks against objects. It is typically made of fabric or soft padded materials and is held in place with bands or straps around the arm, or has a tubular sleeve design; it is not dedicated to the elbow. It is typically used by persons who have thinning skin or skin sores on their elbows/arms, are bedridden, or prone to lack of control with their arms causing injury. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
073704413
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
H933M90068Span-AmericaEASY AIR LRM900682026-09-25
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
H933EZ161896Span-AmericaEZ-DISHEZ1618-962026-02-26
H93392270Span-AmericaSpan Care Convertible922702026-02-25
H933P11634Span-AmericaFloor LiftP116342025-12-03
H933PR13051Span-AmericaOSKA APM2PR13-0512025-12-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00613732113247ROHO QUADTRO SELECT HIGH PROFILE CushionRoho, Inc.KIC2026-09-25
00613732113254ROHO QUADTRO SELECT LOW PROFILE CushionRoho, Inc.KIC2026-09-25
00613732113261ROHO QUADTRO SELECT HIGH PROFILE CushionRoho, Inc.KIC2026-09-25
00613732113278ROHO QUADTRO SELECT LOW PROFILE CushionRoho, Inc.KIC2026-09-25
00613732113285ROHO QUADTRO SELECT LOW PROFILE CushionRoho, Inc.KIC2026-09-25
00613732113292ROHO QUADTRO SELECT HIGH PROFILE CushionRoho, Inc.KIC2026-09-25
00613732113308ROHO QUADTRO SELECT HIGH PROFILE CushionRoho, Inc.KIC2026-09-25
00613732113315ROHO QUADTRO SELECT HIGH PROFILE CushionRoho, Inc.KIC2026-09-25
00613732113322ROHO QUADTRO SELECT LOW PROFILE CushionRoho, Inc.KIC2026-09-25
00613732113339ROHO QUADTRO SELECT LOW PROFILE CushionRoho, Inc.KIC2026-09-25
00613732113346ROHO QUADTRO SELECT HIGH PROFILE CushionRoho, Inc.KIC2026-09-25
00613732113353ROHO QUADTRO SELECT HIGH PROFILE CushionRoho, Inc.KIC2026-09-25
00613732113360ROHO QUADTRO SELECT HIGH PROFILE CushionRoho, Inc.KIC2026-09-25
00613732113377ROHO QUADTRO SELECT HIGH PROFILE CushionRoho, Inc.KIC2026-09-25
00613732113384ROHO QUADTRO SELECT HIGH PROFILE CushionRoho, Inc.KIC2026-09-25
00613732113391ROHO QUADTRO SELECT LOW PROFILE CushionRoho, Inc.KIC2026-09-25
00613732113407ROHO QUADTRO SELECT LOW PROFILE CushionRoho, Inc.KIC2026-09-25
00613732113414ROHO QUADTRO SELECT LOW PROFILE CushionRoho, Inc.KIC2026-09-25
00613732113421ROHO QUADTRO SELECT MID PROFILE CushionRoho, Inc.KIC2026-09-25
00613732113438ROHO QUADTRO SELECT LOW PROFILE CushionRoho, Inc.KIC2026-09-25
00613732113445ROHO QUADTRO SELECT MID PROFILE CushionRoho, Inc.KIC2026-09-25
00613732113452ROHO QUADTRO SELECT LOW PROFILE CushionRoho, Inc.KIC2026-09-25
00613732113469ROHO QUADTRO SELECT LOW PROFILE CushionRoho, Inc.KIC2026-09-25
00613732113476ROHO QUADTRO SELECT LOW PROFILE CushionRoho, Inc.KIC2026-09-25
00613732113483ROHO QUADTRO SELECT MID PROFILE CushionRoho, Inc.KIC2026-09-25
00613732113490ROHO QUADTRO SELECT MID PROFILE CushionRoho, Inc.KIC2026-09-25
00613732113506ROHO QUADTRO SELECT LOW PROFILE CushionRoho, Inc.KIC2026-09-25
00613732113513ROHO QUADTRO SELECT LOW PROFILE CushionRoho, Inc.KIC2026-09-25
00613732113520ROHO QUADTRO SELECT MID PROFILE CushionRoho, Inc.KIC2026-09-25
00089904011497Action®ACTION PRODUCTS, INC.KIC2026-09-22