Roho, Inc.
Active in EUDAMEDUnited Statesfrom SRN EUDAMED FDA SRN US-MF-000018363 FEI 3008630266
Roho, Inc. is a medical device manufacturer based in the United States, with 1,480 devices listed in EUDAMED, FDA GUDID and FDA 510(k) (FDA Class I; EU Class I) and 1 FDA recall as of 13 Nov 2026.
- Devices
- 1,480
- Registrations
- EUDAMEDFDA
- FDA recalls
- 1
Registry facts
- Registries
- EUDAMED 1,029
- FDA GUDID 868
- FDA 510(k) 2
- Device classes
- FDA Class I 852
- EU Class I 628
- Top EMDN categories
- FDA recalls
- Identifiers
- EUDAMED SRN US-MF-000018363
- FDA FEI 3008630266
- DUNS 006614792
At a glance
Market reach
- European Union
- EUDAMED actor
- United States
- FDA FEI, FDA recalls
What Roho, Inc. makes
Roho, Inc. manufactures air-filled chair cushions and wheelchair seat cushions, including models such as the ROHO MID PROFILE Single Compartment Cushion, ROHO QUADTRO SELECT HIGH PROFILE Cushion, ROHO Hybrid Select Cushion, ROHO HIGH PROFILE Dual Compartment Cushion, ROHO AirLITE Cushion, and ROHO Hybrid Elite Dual Compartment Cushion.
These devices are classified as Class I medical devices and are listed in the FDA UDI registry. The company is based in the United States.
Catalogue
Search and filter all 1,480 devicesShowing 1-50 of 1,480
Company details
- EUDAMED SRN
- US-MF-000018363
- FDA FEI number
- 3008630266
- DUNS number
- 006614792
- EUDAMED status
- Active
- EUDAMED registered name
- ROHO, Inc.
- Registered address
- 1501, South 74th St., 62223, Belleville, United States
- PRRC contact
- Steven Louer
FDA recalls
FDA recall records list 1 recall initiated by Roho, Inc., initiated on 2017-03-20. By recorded status: 1 terminated. The reasons filed fall into these groups: manufacturing or quality process. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
Recalls initiated per year
- 2017 1
- 2018 0
- 2019 0
- 2020 0
- 2021 0
- 2022 0
- 2023 0
- 2024 0
- 2025 0
- 2026 0
2017
- 20 Mar 2017 Z-1921-2017 Class II 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.
Full distribution text
- 20 Mar 2017 Z-1921-2017 Class II 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.
Frequently asked questions
How many devices does Roho, Inc. have in the registry?
The registry currently lists 1480 devices for Roho, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Roho, Inc.'s devices?
Among its 50 most recently registered devices, Roho, Inc. has devices listed in EUDAMED (50 devices).
What risk classes do Roho, Inc.'s devices fall under?
Among its 50 most recently registered devices, the classes recorded for Roho, Inc.'s devices are Class I. Each device page shows its own class and authorisation.
Are there FDA recall records for Roho, Inc.?
FDA recall records list 1 recall initiated by Roho, Inc., the most recent initiated on 20 Mar 2017. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Roho, Inc. in the registry?
The most recently registered devices listed for Roho, Inc. include ROHO® CONTOUR SELECT® Cushion, ROHO® PRODIGY® Mattress Overlay System, ROHO® AGILITY® Back Support Direct Mount Hardware and ROHO® QUADTRO SELECT® LOW PROFILE® Cushion.