FDA.reportPublic FDA data

Ride Designs Custom AccuSoft Cushion Extra Outer Spacer Mesh Cover

Primary DI
00850032423137
Brand
Ride Designs Custom AccuSoft Cushion Extra Outer Spacer Mesh Cover
Company
Aspen Seating LLC
Model
AccuSoft Extra Outer Spacer Mesh Cover
Device description
Cover for custom wheelchair cushion
Published
2024-04-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

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
00850032423137PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850032423137008500324231378500324231370850032423137

GMDN Terms#

Term, Definition table
TermDefinition
Medical cushion coverA device intended to cover a medical cushion (e.g., birthing cushion, lumbar cushion, wheelchair cushion) during use to protect the cushion from dirt/debris to maintain hygiene. It may be dedicated to a specific type of cushion or non-dedicated; it is not intended for surgical use and is not intended to cover a pillow primarily used in bed. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
020311895
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
00850032423014Ride Designs Java CushionJC-xxxx2024-04-03
00850032423021Ride Designs Java BackJB-xxxx2024-04-03
00850032423038Ride Designs Decaf BackJB-xxxxD2024-04-03
00850032423045Ride Designs Custom 2 Cushion RCC200RCC2002024-04-03
00850032423052Ride Designs Ride Custom BackRCB200RCB2002024-04-03
00850032423069Ride Designs Ride Custom AccuSoft CushionRCAC-x2024-04-03
00850032423076Ride Designs Resting Postural SupportRPS1002024-04-03
00850032423083Aspen Seating OrthosisASO ASO 2024-04-03
00850032423090Ride Designs Forward Cushion Extra Outer CoverForward Cushion Extra Outer Cover2024-04-03
00850032423106Ride Designs Java Cushion Extra Outer CoverJava Cushion Extra Outer Cover2024-04-03
00850032423113Ride Designs Java Back Extra Outer CoverJava Back Extra Outer Cover2024-04-03
00850032423120Ride Designs Custom 2 Cushion Extra Outer CoverExtra Outer Cover2024-04-03
00850032423175Aspen Recumbent Support OrthosisARSOARSO2024-04-03
00850032423182Aspen Wearable Thoraco-Lumbar Pelvic Sitting Support OrthosisASOW-TLPWASOW=TLPW2024-04-03
00850032423144Ride Designs Custom AccuSoft Cushion Extra Outer Incont CoverAccuSoft Extra Outer Incont Cover2021-09-16
00850032423151Ride Designs Custom Back Extra Outer CoverRCB Extra Outer Cover2021-09-16
00850032423168Ride Designs Custom 2 Cushion Extra Outer Incontinence CoverExtra Outer Incontinence Cover2021-09-16
00850032423007Ride Designs Forward CushionForward Cushion2021-09-07

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Primary DI, Brand, Company table
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