Waffle
240WC Waffle Preinflated Extended Care Bariatric Cushion High ALT.- Sngl
52manufacturers in China registered for this device type
47catalogue numbers in this listing
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 | Ehob, Inc., United States |
|---|---|
| FDA product code | KIC |
| Device type | Cushion, Flotation |
| Device class | Class 1 |
| Regulation | 21 CFR 890.3175 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2020-08-21 |
| Record revised | 2021-06-29 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, manufacturing date |
| Packaging | Box of 6, box of 12, pack of 12, pack of 6 |
Catalogue Numbers
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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
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.