FDA.reportPublic FDA data

Aspen Recumbent Support Orthosis

Primary DI
00850032423175
Brand
Aspen Recumbent Support Orthosis
Company
Aspen Seating LLC
Model
ARSO
Catalog number
ARSO
Device description
Custom recumbent support orthosis (postural support for lying)
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
00850032423175PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850032423175008500324231758500324231750850032423175

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