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Roho, Inc.

US

Last updated September 17, 2026

Information

Country
US
Address
1501 S 74th St, Belleville, IL, 62223
Website
—
LinkedIn
—
Facebook
—
Email
—
Phone
—
PRRC Contact
—
EUDAMED SRN
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FDA FEI Number
3008630266
DUNS Number
006614792

Catalogue (595)

Page 9 of 12
DeviceModel / ReferenceRegistriesClassStatus
ROHO HIGH PROFILE Single Compartment Cushion 1R1110HD
FDA UDI
Class IActive
ROHO MID PROFILE Single Compartment Cushion 1R1110MPC
FDA UDI
Class IActive
ROHO QUADTRO SELECT HIGH PROFILE Cushion QS1311HD
FDA UDI
Class IActive
ROHO MID PROFILE Single Compartment Cushion 1R78M-CH-SR
FDA UDI
Class IActive
ROHO MID PROFILE Single Compartment Cushion 1R1210M-CA-SR
FDA UDI
Class IActive
ROHO QUADTRO SELECT MID PROFILE Cushion QS98MPC
FDA UDI
Class IActive
ROHO HIGH PROFILE Single Compartment Cushion 1R1110C
FDA UDI
Class IActive
ROHO QUADTRO SELECT LOW PROFILE Cushion QS1311LPC
FDA UDI
Class IActive
ROHO QUADTRO SELECT HIGH PROFILE Cushion QS1011C
FDA UDI
Class IActive
ROHO QUADTRO SELECT HIGH PROFILE Cushion QS912C
FDA UDI
Class IActive
ROHO LOW PROFILE Dual Compartment Cushion 2R88LPC
FDA UDI
Class IActive
ROHO HIGH PROFILE Single Compartment Cushion 1R79C
FDA UDI
Class IActive
ROHO QUADTRO SELECT LOW PROFILE Cushion QS56LPC
FDA UDI
Class IActive
ROHO QUADTRO SELECT LOW PROFILE Cushion QS98LPC
FDA UDI
Class IActive
ROHO QUADTRO SELECT HIGH PROFILE Cushion QS1210HD
FDA UDI
Class IActive
ROHO HIGH PROFILE Dual Compartment Cushion 2R1010C
FDA UDI
Class IActive
ROHO HIGH PROFILE Single Compartment Cushion 1R77C
FDA UDI
Class IActive
ROHO Hybrid Select Cushion HS1720C
FDA UDI
Class IActive
ROHO ENHANCER Cushion ENH109C
FDA UDI
Class IActive
ROHO HIGH PROFILE Dual Compartment Cushion 2R109C
FDA UDI
Class IActive
ROHO HIGH PROFILE Single Compartment Cushion 1R87H-CH-SR
FDA UDI
Class IActive
Smart Check Cushion Monitoring Device SMARTCHECK-01
FDA UDI
Class IActive
ROHO QUADTRO SELECT HIGH PROFILE Cushion QS1112C
FDA UDI
Class IActive
ROHO ENHANCER Cushion ENHDEMO
FDA UDI
Class IActive
ROHO QUADTRO SELECT HIGH PROFILE Cushion QS1412C
FDA UDI
Class IActive
ROHO LOW PROFILE Single Compartment Cushion 1R66LPC
FDA UDI
Class IActive
ROHO HIGH PROFILE Single Compartment Cushion 1R66C
FDA UDI
Class IActive
ROHO MID PROFILE Single Compartment Cushion 1RLGMPC
FDA UDI
Class IActive
ROHO ENHANCER Cushion ENH1010DMC
FDA UDI
Class IActive
ROHO HIGH PROFILE Single Compartment Cushion 1R910H-CH-SR
FDA UDI
Class IActive
ROHO ENHANCER Cushion ENH1011C
FDA UDI
Class IActive
ROHO CONTOUR SELECT Cushion CSLGC
FDA UDI
Class IActive
ROHO HIGH PROFILE Single Compartment Cushion 1R1410C
FDA UDI
Class IActive
ROHO LOW PROFILE Single Compartment Cushion 1R88LPC
FDA UDI
Class IActive
ROHO HIGH PROFILE Single Compartment Cushion 1R910C
FDA UDI
Class IActive
ROHO HIGH PROFILE Single Compartment Cushion 1R109HD
FDA UDI
Class IActive
ROHO HIGH PROFILE Single Compartment Cushion 1R129H-CH-SR
FDA UDI
Class IActive
ROHO QUADTRO SELECT MID PROFILE Cushion QS1110MPHD
FDA UDI
Class IActive
ROHO LOW PROFILE Single Compartment Cushion 1R1011LPC
FDA UDI
Class IActive
ROHO CONTOUR SELECT Cushion CS1211C
FDA UDI
Class IActive
ROHO Hybrid Elite Dual Compartment Cushion 2RHE1616C
FDA UDI
Class IActive
ROHO MID PROFILE Single Compartment Cushion 1R1211M-CA-SR
FDA UDI
Class IActive
ROHO HIGH PROFILE Single Compartment Cushion 1R1012H-CH-SR
FDA UDI
Class IActive
ROHO MOSAIC Cushion MOS1616CA
FDA UDI
Class IActive
ROHO QUADTRO SELECT LOW PROFILE Cushion QS88LPC
FDA UDI
Class IActive
ROHO QUADTRO SELECT HIGH PROFILE Cushion QS1011HD
FDA UDI
Class IActive
ROHO MID PROFILE Single Compartment Cushion 1R1112M-CA-SR
FDA UDI
Class IActive
ROHO LOW PROFILE Dual Compartment Cushion 2RLGLPC
FDA UDI
Class IActive
ROHO Hybrid Select Cushion HS1718C
FDA UDI
Class IActive
ROHO CONTOUR SELECT Cushion CS109C
FDA UDI
Class IActive

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Authorities

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FDA Recalls (1)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

DateRecall No.ClassStatusReason
Mar 20, 2017Z-1921-2017—terminated

When the Smart Check tool is used to perform a Smart Setup with one of the affected cushions, it may adversely affect the setup process resulting in an improper cushion setup. Sitting on an over inflated or under inflated Sensor Ready Cushion may reduce or eliminate the benefits provided by the cushion, increasing the risk to skin or to other soft tissue.