ROHO, Inc.

Belleville, IL, US

ROHO, Inc. appears in FDA device records in Belleville, IL. FDA records list 2 510(k) clearances between 1986-06-02 and 1992-09-09, no PMA records and one registered establishment. As of 2026-09-10, FDA records show one recall for this company, and at least one establishment registration is current.

510(k) clearances: 2
PMA records: 0
Recall records: 1
Registered establishments: 1

510(k) clearance history

FDA records hold 2 510(k) clearances for ROHO, Inc. between 1986 and 1992. The busiest year on record is 1986, with 1. The most recent is 1992, with 1.

Clearances by year, as a table

510(k) clearance decisions for ROHO, Inc., by decision year
Year	Clearances
1986	1
1992	1

510(k) clearances on record, most recent first
K number	Device	Product code	Decision	Decision date
K923186	NEXUS WHEELCHAIR CUSHION/FORMERLY BIOTHOTIC	KNN	Substantially Equivalent	1992-09-09
K861327	ROHO HEEL PAD	KIC	Substantially Equivalent	1986-06-02

Registered establishments

FDA registered establishments for ROHO, Inc., with the product codes listed at each
Registration	FEI	Establishment	Address	Registration expires	Product codes listed
3008630266	3008630266	ROHO, Inc.	1501 S 74th St, Belleville, IL 62223 US	2026	FMP FMW IKY JFC KIC KNN KNO

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
Recall	Product	Reason	Classification	Initiated	Status
Z-1921-2017	ROHO HIGH PROFILE Single Compartment Cushion with Sensor Ready Technology and ROHO MID PROFILE Single Compartment Cushion with Sensor Ready Technology.	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.	Class II	2017-03-20	Terminated

Verification record

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Data as of 2026-09-28, FDA export datePage updated 2026-09-05Source: openFDA, public domain