Roho Dual Compartment Cushion
Modified configuration of a ROHO Dual Compartment Cushion. It may be any size and include high, mid, or low profile cells.
Who Else Makes It
Concentrated in Guangdong (14), Jiangsu (8), Fujian (8). 11 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Gcmedica Enterprise Ltd.(Wuxi) | Wuxi | Jiangsu | Contract manufacturer | 55 |
| Fortune Company Ltd. | Huizhou | Guangdong | Contract manufacturer | 23 |
| Dongguan China Effort Healthcare Products Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 17 |
| Jiangsu Yishun Medical Equipment Co., Ltd. | Nantong | Jiangsu | Contract manufacturer | 10 |
| Shenzhen Lantise Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 10 |
| Ehob (Shanghai) Medical Products Co., Ltd. | Pudong | Shanghai | Contract manufacturer | 8 |
| Shanghai Ehob Health Care Products Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 8 |
| EHOB(JiaXing) Medical Product Co., Ltd. | Jiaxing | Zhejiang | Contract manufacturer | 7 |
| Shenzhen Dongjilian Medical Tech Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 5 |
| Good Horse Toys AND Gifts Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 5 |
| Dongguan IMS (FE) Electro-Mechanical Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 4 |
| Shanghai NEO-Medical Import & Export Co., Ltd. | Shanghai | Shanghai | Exporter | 59 |
Showing 12 of 52. All 52 manufacturers in China registered for Cushion, Flotation
Record
| Listed by | Roho, Inc., United States |
|---|---|
| FDA product code | KIC |
| Device type | Cushion, Flotation |
| Device class | Class 1 |
| Regulation | 21 CFR 890.3175 |
| Establishment | Contract manufacturer, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2022-11-25 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 2RMODIFIED | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Varilite | Cascade Designs, Inc. | 736 |
| Star | Ki Mobility | 318 |
| Span-America | Span-America Medical Systems, Inc. | 270 |
| Roho High Profile Single Compartment Cushion | Roho, Inc. | 172 |
| Action® | Action Products, Inc. | 136 |
| Roho Quadtro Select High Profile Cushion | Roho, Inc. | 103 |
| Roho MID Profile Single Compartment Cushion | Roho, Inc. | 93 |
| Roho LOW Profile Single Compartment Cushion | Roho, Inc. | 58 |
| Roho Hybrid Elite Dual Compartment Cushion | Roho, Inc. | 57 |
| Roho Hybrid Elite SR Single Compartment Cushion | Roho, Inc. | 56 |
| Drivemedical | Drive DeVilbiss Healthcare | 56 |
| Roho Contour Select Cushion | Roho, Inc. | 52 |
Showing 12 of 127. All products under Cushion, Flotation
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K861327 | 1986-06-02 |
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2017-03-20 | Class II | Equipment maintenance | 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 Cushi | 5646 units | 2019-05-10 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.