Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008630266

FEI Number

3008630266

Entity Name

ROHO, Inc.

City/State/Country

Belleville, IL, US

Establishment Address

1501 S 74th St, Belleville, IL 62223, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device

Owner / Operator

ROHO, INC. (Owner Number: 1419507)

Owner / Operator Contact Address

1501 S. 74th St., --, Belleville, IL 62223, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

ROHO® DRY FLOATATION® Bariatric Kit ROHO® DRY FLOATATION® Mattress Overlay System ROHO® PRODIGY® Mattress Overlay System ROHO® SOFFLEX® 2 Mattress Overlay System ROHO® DRY FLOATATION® Isolette ROHO® DRY FLOATATION® Bariatric Mattress Overlay System ROHO® AGILITY® Back System Quick Release Hardware ROHO® AGILITY® Back System Direct Mount Hardware THE ADAPTOR® PAD ROHO® AGILITY® Max Contour Back System ROHO® Hybrid Elite SR Single Compartment Cushion ROHO® Hybrid Select Cushion ROHO® AirLITE® Cushion ROHO® Hybrid Elite® Dual Compartment Cushion ROHO® HIGH PROFILE® Single Compartment Cushion ROHO® LOW PROFILE® Single Compartment Cushion ROHO® MID PROFILE Single Compartment Cushion ROHO® QUADTRO SELECT® LOW PROFILE® Cushion ROHO® CONTOUR SELECT® Cushion ROHO® LOW PROFILE® Dual Compartment Cushion ROHO® HIGH PROFILE® Dual Compartment Cushion ROHO® Recliner System ROHO® MID PROFILE Dual Compartment Cushion ROHO® ENHANCER® Cushion ROHO® MOSAIC® Cushion ROHO® QUADTRO SELECT® HIGH PROFILE® Cushion ROHO® QUADTRO SELECT® MID PROFILE Cushion ROHO® DRY FLOATATION® Nesting Pad ROHO® MINI-MAX® CUSHION THE ADAPTOR® PAD ROHO® Toilet Seat Cushion ROHO® Shower/Commode Cushion ROHO® PACK-IT® CUSHION ROHO® DRY FLOATATION® Head/Neck Pillow ROHO® Reusable Mattress Overlay Bariatric System Cover ROHO® Reusable Mattress Overlay System Cover ROHO® Mattress Overlay Enclosure Cover Smart Check Cushion Monitoring Device

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IKY	Mattress, Flotation Therapy, Non-Powered	General Hospital	Class 1	880.5150	1994-08-01
KNN	Components, Wheelchair	Physical Medicine	Class 1	890.3920	2018-02-28
KIC	Cushion, Flotation	Physical Medicine	Class 1	890.3175	1995-08-28
FMP	Protector, Skin Pressure	General Hospital	Class 1	880.6450	2002-09-04
FMW	Cover, Mattress (Medical Purposes)	General Hospital	Class 1	880.6190	2012-10-31
JFC	System, Pressure Measurement, Intermittent	Physical Medicine	Class 1	890.1600	2002-09-04

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

ROHO, INC.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008630266. Last updated year: 2026. Please use registration number 3008630266 when referencing this establishment in official correspondence.