FDA.reportPublic FDA data

Ride Designs Java Cushion

Primary DI
00850032423014
Brand
Ride Designs Java Cushion
Company
Aspen Seating LLC
Model
JC-xxxx
Device description
Prefabricated adjustable skin protection and positioning 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

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
00850032423014PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850032423014008500324230148500324230140850032423014

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
3035135445shelly@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
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
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
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