FDA.reportPublic FDA data

ROHO AirLITE Cushion

Primary DI
00613732058401
Brand
ROHO AirLITE Cushion
Company
Roho, Inc.
Model
ALDEMO
Published
2022-08-26
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
KICCushion, Flotation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KICCushion, FlotationPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00613732058401PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00613732058401006137320584016137320584010613732058401

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

Regulatory Flags#

DUNS number
006614792
Device count
1
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00613732113247ROHO QUADTRO SELECT HIGH PROFILE CushionQS1013HD2026-09-25
00613732113254ROHO QUADTRO SELECT LOW PROFILE CushionQS108LPHD2026-09-25
00613732113261ROHO QUADTRO SELECT HIGH PROFILE CushionQS1114HD2026-09-25
00613732113278ROHO QUADTRO SELECT LOW PROFILE CushionQS1210LPHD2026-09-25
00613732113285ROHO QUADTRO SELECT LOW PROFILE CushionQS1212LPHD2026-09-25
00613732113292ROHO QUADTRO SELECT HIGH PROFILE CushionQS1213HD2026-09-25
00613732113308ROHO QUADTRO SELECT HIGH PROFILE CushionQS1214HD2026-09-25
00613732113315ROHO QUADTRO SELECT HIGH PROFILE CushionQS128HD2026-09-25
00613732113322ROHO QUADTRO SELECT LOW PROFILE CushionQS1310LPHD2026-09-25
00613732113339ROHO QUADTRO SELECT LOW PROFILE CushionQS1311LPHD2026-09-25
00613732113346ROHO QUADTRO SELECT HIGH PROFILE CushionQS1313HD2026-09-25
00613732113353ROHO QUADTRO SELECT HIGH PROFILE CushionQS1314HD2026-09-25
00613732113360ROHO QUADTRO SELECT HIGH PROFILE CushionQS138HD2026-09-25
00613732113377ROHO QUADTRO SELECT HIGH PROFILE CushionQS148HD2026-09-25
00613732113384ROHO QUADTRO SELECT HIGH PROFILE CushionQS149HD2026-09-25
00613732113391ROHO QUADTRO SELECT LOW PROFILE CushionQS66LPHD2026-09-25
00613732113407ROHO QUADTRO SELECT LOW PROFILE CushionQS67LPHD2026-09-25
00613732113414ROHO QUADTRO SELECT LOW PROFILE CushionQS77LPHD2026-09-25
00613732113421ROHO QUADTRO SELECT MID PROFILE CushionQS77MPHD2026-09-25
00613732113438ROHO QUADTRO SELECT LOW PROFILE CushionQS78LPHD2026-09-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00613732113247ROHO QUADTRO SELECT HIGH PROFILE CushionRoho, Inc.KIC2026-09-25
00613732113254ROHO QUADTRO SELECT LOW PROFILE CushionRoho, Inc.KIC2026-09-25
00613732113261ROHO QUADTRO SELECT HIGH PROFILE CushionRoho, Inc.KIC2026-09-25
00613732113278ROHO QUADTRO SELECT LOW PROFILE CushionRoho, Inc.KIC2026-09-25
00613732113285ROHO QUADTRO SELECT LOW PROFILE CushionRoho, Inc.KIC2026-09-25
00613732113292ROHO QUADTRO SELECT HIGH PROFILE CushionRoho, Inc.KIC2026-09-25
00613732113308ROHO QUADTRO SELECT HIGH PROFILE CushionRoho, Inc.KIC2026-09-25
00613732113315ROHO QUADTRO SELECT HIGH PROFILE CushionRoho, Inc.KIC2026-09-25
00613732113322ROHO QUADTRO SELECT LOW PROFILE CushionRoho, Inc.KIC2026-09-25
00613732113339ROHO QUADTRO SELECT LOW PROFILE CushionRoho, Inc.KIC2026-09-25
00613732113346ROHO QUADTRO SELECT HIGH PROFILE CushionRoho, Inc.KIC2026-09-25
00613732113353ROHO QUADTRO SELECT HIGH PROFILE CushionRoho, Inc.KIC2026-09-25
00613732113360ROHO QUADTRO SELECT HIGH PROFILE CushionRoho, Inc.KIC2026-09-25
00613732113377ROHO QUADTRO SELECT HIGH PROFILE CushionRoho, Inc.KIC2026-09-25
00613732113384ROHO QUADTRO SELECT HIGH PROFILE CushionRoho, Inc.KIC2026-09-25
00613732113391ROHO QUADTRO SELECT LOW PROFILE CushionRoho, Inc.KIC2026-09-25
00613732113407ROHO QUADTRO SELECT LOW PROFILE CushionRoho, Inc.KIC2026-09-25
00613732113414ROHO QUADTRO SELECT LOW PROFILE CushionRoho, Inc.KIC2026-09-25
00613732113421ROHO QUADTRO SELECT MID PROFILE CushionRoho, Inc.KIC2026-09-25
00613732113438ROHO QUADTRO SELECT LOW PROFILE CushionRoho, Inc.KIC2026-09-25
00613732113445ROHO QUADTRO SELECT MID PROFILE CushionRoho, Inc.KIC2026-09-25
00613732113452ROHO QUADTRO SELECT LOW PROFILE CushionRoho, Inc.KIC2026-09-25
00613732113469ROHO QUADTRO SELECT LOW PROFILE CushionRoho, Inc.KIC2026-09-25
00613732113476ROHO QUADTRO SELECT LOW PROFILE CushionRoho, Inc.KIC2026-09-25
00613732113483ROHO QUADTRO SELECT MID PROFILE CushionRoho, Inc.KIC2026-09-25
00613732113490ROHO QUADTRO SELECT MID PROFILE CushionRoho, Inc.KIC2026-09-25
00613732113506ROHO QUADTRO SELECT LOW PROFILE CushionRoho, Inc.KIC2026-09-25
00613732113513ROHO QUADTRO SELECT LOW PROFILE CushionRoho, Inc.KIC2026-09-25
00613732113520ROHO QUADTRO SELECT MID PROFILE CushionRoho, Inc.KIC2026-09-25
00089904011497Action®ACTION PRODUCTS, INC.KIC2026-09-22