FDA.reportPublic FDA data

Invacare® ContourU® Naked Back

Primary DI
00841447102878
Brand
Invacare® ContourU® Naked Back
Company
INVACARE CORPORATION
Model
CM02B
Catalog number
CM02B
Device description
ContourU Naked Back
Published
2019-06-05
Public version status
Update
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
00841447102878PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841447102878008414471028788414471028780841447102878

GMDN Terms#

Term, Definition table
TermDefinition
Wheelchair cushionA padded device designed to provide support, comfort, and assistance to the occupant of a wheelchair. It may be used to improve posture, provide back and/or side support, compensate for seat height, relieve stress points, and provide pressure alleviation for the buttocks, lumbar region, and the legs, and/or to provide 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
+1(440)329-6000orders@invacare.com
(440) 329-6000orders@invacareamerica.com

Regulatory Flags#

DUNS number
076916246
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00841447116431Invacare® Alternating Air Mattress & PumpMA101BLMA101BL2026-05-01
00841447116448Invacare® Alternating Air Mattress & PumpMA101BKMA101BK2026-05-01
00841447116455Invacare® Alternating Air Mattress & Pump with Static ModeMA102BLMA102BL2026-05-01
00841447116462Invacare® Alternating Air Mattress & Pump with Static ModeMA102BKMA102BK2026-05-01
00841447116479Easy Glide Transport Chair for InvacareEGTC19STFSBUEGTC19STFSBU2026-04-10
00841447116486Easy Glide Transport Chair for InvacareEGTC19STFSBKEGTC19STFSBK2026-04-10
00841447116493Easy Glide Transport Chair for InvacareEGTC19STRSBUEGTC19STRSBU2026-04-10
00841447116509Easy Glide Transport Chair for InvacareEGTC19STRSBKEGTC19STRSBK2026-04-10
00841447116516Easy Glide Transport Chair for InvacareEGTC19ALRSBUEGTC19ALRSBU2026-04-10
00841447116523Easy Glide Transport Chair for InvacareEGTC19ALRSBKEGTC19ALRSBK2026-04-10
00841447109754Invacare® Think Soft® Long Term Care Bed Positioning DeviceIHCSTSPD-QSPIHCSTSPD-QSP2026-03-02
00841447116301Easy Glide Wheelchair for InvacareEGWC16STRSBUEGWC16STRSBU2026-02-13
00841447116318Easy Glide Wheelchair for InvacareEGWC16STRSBKEGWC16STRSBK2026-02-13
00841447116325Easy Glide Wheelchair for InvacareEGWC16STREBUEGWC16STREBU2026-02-13
00841447116332Easy Glide Wheelchair for InvacareEGWC16STREBKEGWC16STREBK2026-02-13
00841447116349Easy Glide Wheelchair for InvacareEGWC18STRSBUEGWC18STRSBU2026-02-13
00841447116356Easy Glide Wheelchair for InvacareEGWC18STRSBKEGWC18STRSBK2026-02-13
00841447116363Easy Glide Wheelchair for InvacareEGWC18STREBKEGWC18STREBK2026-02-13
00841447116370Easy Glide Wheelchair for InvacareEGWC18STREBUEGWC18STREBU2026-02-13
00841447116387Easy Glide Wheelchair for InvacareEGWC20STRSBUEGWC20STRSBU2026-02-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10080196312276MEDLINEMEDLINE INDUSTRIES, INC.IMP2026-02-04
09420082696471Spex LimitedSPEX LIMITEDIMP2025-11-07
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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
09420082696747Spex LimitedSPEX LIMITEDIMP2025-11-07
09420082696754Spex LimitedSPEX LIMITEDIMP2025-11-07