FDA Registration
Active
🇺🇸 United States
ROHO, Inc.
Reg #: 3008630266
·
FEI: 3008630266
·
Expires 2026
Products
7
Proprietary Names
52
Establishment Types
3
Classifications
7
Registration Details
- Registration Name
- ROHO, Inc.
- Registration Number
- 3008630266
- FEI Number
- 3008630266
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 1501 S 74th St
- City
- Belleville
- State
- IL
- ZIP
- 62223
- Country
- US
Owner / Operator
- Firm Name
- ROHO, INC.
- Operator Number
- 1419507
- Address
- 1501 S. 74th St., --
- City
- Belleville
- State
- IL
- Postal Code
- 62223
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Mattress, Flotation Therapy, Non-Powered | IKY | Class 1 | General Hospital | No | 1994-08-01 |
| Components, Wheelchair | KNN | Class 1 | Physical Medicine | No | 2018-02-28 |
| Cushion, Flotation | KIC | Class 1 | Physical Medicine | No | 1995-08-28 |
| Protector, Skin Pressure | FMP | Class 1 | General Hospital | No | 2002-09-04 |
| Cover, Mattress (Medical Purposes) | FMW | Class 1 | General Hospital | No | 2012-10-31 |
| System, Pressure Measurement, Intermittent | JFC | Class 1 | Physical Medicine | No | 2002-09-04 |
| Accessories, Wheelchair | KNO | Class 1 | Physical Medicine | No | 2002-09-04 |
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
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
ROHO® Hybrid Elite® Cushion Cover
ROHO® AirLITE® Cushion Cover
ROHO® Recliner System Cover
ROHO® Heavy Duty Cushion Cover
ROHO® AGILITY® Lumbar Support Pad
ROHO® SELECT Cushion Cover
ROHO® Standard Cushion Cover
ROHO® AGILITY CARBON® Min Contour Back Support
ROHO® AGILITY CARBON® Mid Contour Back Support
ROHO® AGILITY® Back System Fixed Hardware
ROHO® AGILITY® Aluminum Mid Contour Back Support
ROHO® AGILITY® UniTrack Rail
ROHO® AGILITY® Aluminum Min Contour Back Support
ROHO® Contour Base
ROHO® Planar Solid Seat Insert
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)