FDA.report

ROHO AirLITE Cushion

Primary DI
00613732087296
Brand
ROHO AirLITE Cushion
Company
Roho, Inc.
Model
AL1816HD
Published
2022-09-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
KICCushion, Flotation

Product Code Classifications

CodeDeviceSpecialtyClass
KICCushion, FlotationPhysical Medicine1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00613732087296PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00613732087296006137320872966137320872960613732087296

GMDN Terms

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

Regulatory Flags

DUNS number
006614792
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
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
00613732114879ROHO HIGH PROFILE Single Compartment Cushion1R77HD2026-03-09
00613732114886ROHO HIGH PROFILE Single Compartment Cushion1R78HD2026-03-09
00613732114893ROHO HIGH PROFILE Single Compartment Cushion1R79HD2026-03-09
00613732114909ROHO HIGH PROFILE Single Compartment Cushion1R810HD2026-03-09
00613732114916ROHO HIGH PROFILE Single Compartment Cushion1R811HD2026-03-09
00613732114923ROHO HIGH PROFILE Single Compartment Cushion1R86HD2026-03-09
00613732114930ROHO HIGH PROFILE Single Compartment Cushion1R87HD2026-03-09
00613732114947ROHO HIGH PROFILE Single Compartment Cushion1R88HD2026-03-09
00613732114954ROHO HIGH PROFILE Single Compartment Cushion1R89HD2026-03-09
00613732114961ROHO HIGH PROFILE Single Compartment Cushion1R96HD2026-03-09
00613732114978ROHO HIGH PROFILE Single Compartment Cushion1R97HD2026-03-09
00613732114985ROHO HIGH PROFILE Single Compartment Cushion1R98HD2026-03-09
00613732114992ROHO LOW PROFILE Single Compartment Cushion1R1010LPHD2026-03-09
00613732115005ROHO LOW PROFILE Single Compartment Cushion1R1011LPHD2026-03-09
00613732115012ROHO LOW PROFILE Single Compartment Cushion1R108LPHD2026-03-09

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
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
00613732115111ROHO LOW PROFILE Single Compartment CushionRoho, Inc.KIC2026-03-09