Jay Basic Back

GUDID 00016958050127

The JAY® Basic wheelchair back is designed to increase sitting tolerance and stability by adding a rigid component to the wheelchair that provides long-term postural support.

SUNRISE MEDICAL (US) LLC

Gel-filled chair cushion
Primary Device ID00016958050127
NIH Device Record Key1f0515c4-4668-4180-9421-ec9ef709d9cd
Commercial Distribution StatusIn Commercial Distribution
Brand NameJay Basic Back
Version Model NumberBasic Back
Company DUNS962525056
Company NameSUNRISE MEDICAL (US) 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 Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Countertrue

Device Identifiers

Device Issuing AgencyDevice ID
GS100016958050127 [Primary]

FDA Product Code

IMPCushion, Wheelchair

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2025-05-20
Device Publish Date2023-09-12

Devices Manufactured by SUNRISE MEDICAL (US) LLC

00016958050110 - Jay Easy2025-05-20 The JAY® Easy® is a skin protection and positioning wheelchair cushion featuring a hi-resiliency, contoured foam base that acc
00016958050127 - Jay Basic Back2025-05-20The JAY® Basic wheelchair back is designed to increase sitting tolerance and stability by adding a rigid component to the wheelchair that provides long-term postural support.
00016958050127 - Jay Basic Back2025-05-20 The JAY® Basic wheelchair back is designed to increase sitting tolerance and stability by adding a rigid component to the wheel
00016958050134 - Jay Focus Point Back2025-05-20 The JAY® Focus Point wheelchair back is a three-piece contoured backrest featuring a reinforced contoured aluminum shell, multi
00016958053135 - Jay Encompass Back2025-05-20 The JAY® Encompass is a fully configurable wheelchair back that offers a wide range of sizes and specifications, including made
00016958053647 - Zippie Voyage2025-05-20 The Zippie Voyage® is a lightweight highly adjustable early intervention stroller. In addition to adjustable tilt and recline,
00016958056563 - Jay Fusion 2025-05-20 The JAY Fusion® is an adjustable wheelchair cushion engineered to protect against pressure injuries that features the choice of
00016958058451 - Switch-It 2025-05-20 Alternative drive controls for users who cannot use standard power wheelchair controls.
00016958059694 - Xtreme X8 4WD2025-05-20 Through sand or snow and up or down curbs, the Extreme X8 is a true all-terrain power wheelchair. Unrivaled 4x4 off-road perform

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