Facility

ROHO, Inc.

1 recall(s) on record — most severe on record: Class II.

Key facts

1recalls · worst Class II

—inspections in our data

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	3008630266
Establishment type	Complaint File Establishment per 21 CFR 820.198; Manufacture Medical Device
Location	1501 S 74th St Belleville, IL, US 62223
Registration status	Active · expires 2026
Parent company	ROHO, INC. (owner-operator 1419507)
Brand names	Smart Check Cushion Monitoring Device

Activity by year

Recalls (1)

Devices registered here (1)

System, Pressure Measurement, Intermittent
Product code JFC (opens in a new tab) · Class I · Physical Medicine · 21 CFR 890.1600

Recalls & enforcement

Class IITerminated2017-03-20
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 …

All facilities operated by ROHO, INC.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “ROHO, Inc. (FEI 3008630266) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3008630266-roho-inc/

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