FDA.reportPublic FDA data

ROHO HIGH PROFILE Single Compartment Cushion

Primary DI
00613732114961
Brand
ROHO HIGH PROFILE Single Compartment Cushion
Company
Roho, Inc.
Model
1R96HD
Published
2026-03-09
Public version status
New
Distribution status
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
00613732114961PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00613732114961006137321149616137321149610613732114961

GMDN Terms#

Term, Definition table
TermDefinition
Air-filled chair cushionA static-air-inflated pad designed to be placed on the seat of a chair to distribute an occupant's body weight over the surface of the buttocks, typically to relieve pressure points for comfort and to prevent pressure sores. It is commonly used for elderly immobilized patients especially in cases of decubitus ulcers, patients with disabilities, or patients with low body fat. It may be used in a wheelchair. 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