FDA.reportPublic FDA data

Smart Check Cushion Monitoring Device

Primary DI
00613732090289
Brand
Smart Check Cushion Monitoring Device
Company
Roho, Inc.
Model
SMARTCHK01-DEMO
Published
2022-11-25
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
JFCSystem, Pressure Measurement, Intermittent

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JFCSystem, Pressure Measurement, IntermittentPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00613732090289PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00613732090289006137320902896137320902890613732090289

GMDN Terms#

Term, Definition table
TermDefinition
Wheelchair occupant position sensorAn electrically-powered device intended to be used with a wheelchair to provide the occupant with feedback on their seating position/placement. It is in the form of a flat, electronic pad placed on the seat of the wheelchair, or attached to a seat cushion, and which responds to physical stimuli. After the occupant establishes a sitting position, the device can signal unwanted movement from the position and/or indicate when the position has been prolonged sufficient to put the occupant at risk of pressure-associated complications; data may be transmitted to an off-the-shelf computing device for recording/display.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity0 Percent (%) Relative Humidity93 Percent (%) Relative Humidity
Storage Environment Temperature-13 Degrees Fahrenheit158 Degrees Fahrenheit

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
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
00613732114879ROHO HIGH PROFILE Single Compartment Cushion1R77HD2026-03-09

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