FDA.reportPublic FDA data

Ride Designs Java Back Extra Outer Cover

Primary DI
00850032423113
Brand
Ride Designs Java Back Extra Outer Cover
Company
Aspen Seating LLC
Model
Java Back Extra Outer Cover
Device description
Cover for prefabricated wheelchair back support
Published
2024-04-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

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
00850032423113PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850032423113008500324231138500324231130850032423113

GMDN Terms#

Term, Definition table
TermDefinition
Wheelchair seat cushionA padded device designed to provide support, comfort, and assistance to the occupant of a wheelchair typically by improving posture, providing back and/or side support, compensating for seat height, relieving stress points, and providing pressure alleviation for the buttocks, lumbar region, and the legs, and/or by providing an antislip mechanism. The device is typically situated behind the lower lumbar region of the back or under the buttocks and/or legs while the occupant is seated. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
303-513-5445shelly@ridedesigns.com

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
00850032423120Ride Designs Custom 2 Cushion Extra Outer CoverExtra Outer Cover2024-04-03
00850032423137Ride Designs Custom AccuSoft Cushion Extra Outer Spacer Mesh CoverAccuSoft Extra Outer Spacer Mesh 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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07540147004040Matrx MAC BackMotion Concepts IncIMP2026-07-03
07540147004057Matrx MAC-HUG BackMotion Concepts IncIMP2026-07-03
10080196312276MEDLINEMEDLINE INDUSTRIES, INC.IMP2026-02-04
09420082696471Spex LimitedSPEX LIMITEDIMP2025-11-07
09420082696488Spex LimitedSPEX LIMITEDIMP2025-11-07
09420082696495Spex LimitedSPEX LIMITEDIMP2025-11-07
09420082696501Spex LimitedSPEX LIMITEDIMP2025-11-07
09420082696518Spex LimitedSPEX LIMITEDIMP2025-11-07
09420082696525Spex LimitedSPEX LIMITEDIMP2025-11-07
09420082696532Spex LimitedSPEX LIMITEDIMP2025-11-07
09420082696549Spex LimitedSPEX LIMITEDIMP2025-11-07
09420082696556Spex LimitedSPEX LIMITEDIMP2025-11-07
09420082696563Spex LimitedSPEX LIMITEDIMP2025-11-07
09420082696570Spex LimitedSPEX LIMITEDIMP2025-11-07
09420082696587Spex LimitedSPEX LIMITEDIMP2025-11-07
09420082696594Spex LimitedSPEX LIMITEDIMP2025-11-07
09420082696600Spex LimitedSPEX LIMITEDIMP2025-11-07
09420082696617Spex LimitedSPEX LIMITEDIMP2025-11-07
09420082696624Spex LimitedSPEX LIMITEDIMP2025-11-07
09420082696631Spex LimitedSPEX LIMITEDIMP2025-11-07
09420082696648Spex LimitedSPEX LIMITEDIMP2025-11-07
09420082696655Spex LimitedSPEX LIMITEDIMP2025-11-07
09420082696662Spex LimitedSPEX LIMITEDIMP2025-11-07
09420082696679Spex LimitedSPEX LIMITEDIMP2025-11-07
09420082696686Spex LimitedSPEX LIMITEDIMP2025-11-07
09420082696693Spex LimitedSPEX LIMITEDIMP2025-11-07
09420082696709Spex LimitedSPEX LIMITEDIMP2025-11-07
09420082696716Spex LimitedSPEX LIMITEDIMP2025-11-07
09420082696723Spex LimitedSPEX LIMITEDIMP2025-11-07
09420082696730Spex LimitedSPEX LIMITEDIMP2025-11-07