Ride Designs Custom AccuSoft Cushion Extra Outer Incont Cover

GUDID 00850032423144

Aspen Seating LLC

Medical cushion cover
Primary Device ID00850032423144
NIH Device Record Key2fc00283-4653-4f56-84e2-888a9fcce394
Commercial Distribution StatusIn Commercial Distribution
Brand NameRide Designs Custom AccuSoft Cushion Extra Outer Incont Cover
Version Model NumberAccuSoft Extra Outer Incont Cover
Company DUNS020311895
Company NameAspen Seating LLC
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Device Identifiers

Device Issuing AgencyDevice ID
GS100850032423144 [Primary]

FDA Product Code

IMPCushion, Wheelchair

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-09-24
Device Publish Date2021-09-16

Devices Manufactured by Aspen Seating LLC

00850032423014 - Ride Designs Java Cushion2024-04-11 Prefabricated adjustable skin protection and positioning wheelchair cushion
00850032423021 - Ride Designs Java Back2024-04-11 Prefabricated wheelchair back support
00850032423038 - Ride Designs Decaf Back2024-04-11 Prefabricated pediatric wheelchair back support
00850032423045 - Ride Designs Custom 2 Cushion 2024-04-11 Custom wheelchair cushion
00850032423052 - Ride Designs Ride Custom Back2024-04-11 Custom wheelchair back support
00850032423069 - Ride Designs Ride Custom AccuSoft Cushion2024-04-11 Custom Wheelchair Cushion
00850032423076 - Ride Designs Resting Postural Support2024-04-11 Custom full body postural support for positioning outside of wheelchair
00850032423083 - Aspen Seating Orthosis2024-04-11 Custom seating orthosis

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.