FDA.reportPublic FDA data

ROHO Hybrid Elite Dual Compartment Cushion

Primary DI
00613732101077
Brand
ROHO Hybrid Elite Dual Compartment Cushion
Company
Roho, Inc.
Model
2RHE1816C
Published
2022-09-02
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
00613732101077PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00613732101077006137321010776137321010770613732101077

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
00613732090289Smart Check Cushion Monitoring Device SMARTCHK01-DEMO2022-11-25
00613732098056ROHO QUADTRO SELECT LOW PROFILE CushionQS99LPDMC2022-11-18
00613732061166ROHO QUADTRO SELECT HIGH PROFILE CushionQS99DMC2022-11-11
00613732058418ROHO MOSAIC CushionMOSDEMO2022-11-04
00613732055127ROHO QUADTRO SELECT CushionQSDEMO2022-09-02
00613732061173ROHO QUADTRO SELECT CushionQS1010DMC2022-09-02
00613732101879ROHO Hybrid Elite Dual Compartment Cushion2RHEDEMO2022-09-02
00613732109318ROHO Hybrid Select CushionHSDEMO2022-09-02
00613732000790ROHO ENHANCER CushionENH1010DMC2022-08-26
00613732000837ROHO ENHANCER CushionENH109DMC2022-08-26
00613732001117ROHO ENHANCER CushionENH99DMC2022-08-26
00613732057268ROHO ENHANCER CushionENHDEMO2022-08-26
00613732058401ROHO AirLITE CushionALDEMO2022-08-26
00613732059569ROHO CONTOUR SELECT CushionCSDEMO2022-08-26
00613732061333ROHO CONTOUR SELECT CushionCS99DMC2022-08-26
00613732114824ROHO HIGH PROFILE Single Compartment Cushion1R108HD2026-03-09
00613732114831ROHO HIGH PROFILE Single Compartment Cushion1R118HD2026-03-09
00613732114848ROHO HIGH PROFILE Single Compartment Cushion1R119HD2026-03-09
00613732114855ROHO HIGH PROFILE Single Compartment Cushion1R66HD2026-03-09
00613732114862ROHO HIGH PROFILE Single Compartment Cushion1R67HD2026-03-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10197344014347MEDLINEMEDLINE INDUSTRIES, INC.KIC2026-05-08
00613732114824ROHO HIGH PROFILE Single Compartment CushionRoho, Inc.KIC2026-03-09
00613732114831ROHO HIGH PROFILE Single Compartment CushionRoho, Inc.KIC2026-03-09
00613732114848ROHO HIGH PROFILE Single Compartment CushionRoho, Inc.KIC2026-03-09
00613732114855ROHO HIGH PROFILE Single Compartment CushionRoho, Inc.KIC2026-03-09
00613732114862ROHO HIGH PROFILE Single Compartment CushionRoho, Inc.KIC2026-03-09
00613732114879ROHO HIGH PROFILE Single Compartment CushionRoho, Inc.KIC2026-03-09
00613732114886ROHO HIGH PROFILE Single Compartment CushionRoho, Inc.KIC2026-03-09
00613732114893ROHO HIGH PROFILE Single Compartment CushionRoho, Inc.KIC2026-03-09
00613732114909ROHO HIGH PROFILE Single Compartment CushionRoho, Inc.KIC2026-03-09
00613732114916ROHO HIGH PROFILE Single Compartment CushionRoho, Inc.KIC2026-03-09
00613732114923ROHO HIGH PROFILE Single Compartment CushionRoho, Inc.KIC2026-03-09
00613732114930ROHO HIGH PROFILE Single Compartment CushionRoho, Inc.KIC2026-03-09
00613732114947ROHO HIGH PROFILE Single Compartment CushionRoho, Inc.KIC2026-03-09
00613732114954ROHO HIGH PROFILE Single Compartment CushionRoho, Inc.KIC2026-03-09
00613732114961ROHO HIGH PROFILE Single Compartment CushionRoho, Inc.KIC2026-03-09
00613732114978ROHO HIGH PROFILE Single Compartment CushionRoho, Inc.KIC2026-03-09
00613732114985ROHO HIGH PROFILE Single Compartment CushionRoho, Inc.KIC2026-03-09
00613732114992ROHO LOW PROFILE Single Compartment CushionRoho, Inc.KIC2026-03-09
00613732115005ROHO LOW PROFILE Single Compartment CushionRoho, Inc.KIC2026-03-09
00613732115012ROHO LOW PROFILE Single Compartment CushionRoho, Inc.KIC2026-03-09
00613732115029ROHO LOW PROFILE Single Compartment CushionRoho, Inc.KIC2026-03-09
00613732115036ROHO LOW PROFILE Single Compartment CushionRoho, Inc.KIC2026-03-09
00613732115043ROHO LOW PROFILE Single Compartment CushionRoho, Inc.KIC2026-03-09
00613732115050ROHO LOW PROFILE Single Compartment CushionRoho, Inc.KIC2026-03-09
00613732115067ROHO LOW PROFILE Single Compartment CushionRoho, Inc.KIC2026-03-09
00613732115074ROHO LOW PROFILE Single Compartment CushionRoho, Inc.KIC2026-03-09
00613732115081ROHO LOW PROFILE Single Compartment CushionRoho, Inc.KIC2026-03-09
00613732115098ROHO LOW PROFILE Single Compartment CushionRoho, Inc.KIC2026-03-09
00613732115104ROHO LOW PROFILE Single Compartment CushionRoho, Inc.KIC2026-03-09