ConformX
ConformX Replacement Mattress, 2 Way, 150kg, Welded
Who Else Makes It
Concentrated in Jiangsu (8), Guangdong (8), Zhejiang (4). 10 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Metacare Industrial Ltd | Guangzhou | Guangdong | Contract manufacturer | 17 |
| Foshan Dongfang Medical Equipment Manufactory(Ltd) | Foshan | Guangdong | Contract manufacturer | 14 |
| Suzhou Minhua Medical Equipment Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 9 |
| Ehob (Shanghai) Medical Products Co., Ltd. | Pudong | Shanghai | Contract manufacturer | 8 |
| Shanghai Ehob Health Care Products Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 8 |
| Xiamen Senyang Co., Ltd. | Xiamen | Fujian | Contract manufacturer | 7 |
| EHOB(JiaXing) Medical Product Co., Ltd. | Jiaxing | Zhejiang | Contract manufacturer | 7 |
| SHL Healthcare Ltd. | Shenzhen | Guangdong | Contract manufacturer | 5 |
| JHQ NEW Material Technology Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 3 |
| Shanghai Shenbao Mattress Factory | Shanghai | Shanghai | Contract manufacturer | 2 |
| Ningbo Ningyuan Import & Export Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 80 |
| Yearstar Healthcare Technology Co., Ltd. | Jiangyin | Jiangsu | Contract manufacturer | 43 |
Showing 12 of 30. All 30 manufacturers in China registered for Mattress, Flotation Therapy, Non-Powered
Record
| Listed by | Arjohuntleigh AB, Sweden |
|---|---|
| FDA product code | IKY |
| Device type | Mattress, Flotation Therapy, Non-Powered |
| Device class | Class 1 |
| Regulation | 21 CFR 880.5150 |
| Establishment | Specification developer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2022-07-30 |
| Record revised | 2023-07-31 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Over the counter | Yes |
| Label carries | lot or batch number, manufacturing date |
| Distribution end date | 2023-07-30 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 150CX000/000 | In distribution | |
| 150CX000/000W | In distribution | |
| CS000/000 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Span-America | Span-America Medical Systems, Inc. | 720 |
| C-Matt | Casco Manufacturing Solutions, Inc. | 431 |
| Cmatt | Casco Manufacturing Solutions, Inc. | 62 |
| Drivemedical | Drive DeVilbiss Healthcare | 40 |
| Drive | Drive DeVilbiss Healthcare | 39 |
| Lounge Doctor | Legs 4 Life, LLC | 28 |
| PrevaMatt | Joerns Healthcare | 28 |
| Accumax Surface | Hill-ROM, Inc. | 26 |
| NP50 Surface | Hill-ROM, Inc. | 23 |
| Waffle | Ehob, Inc. | 22 |
| GeoMattress | Span-America Medical Systems, Inc. | 19 |
| NP100 Surface | Hill-ROM, Inc. | 19 |
Showing 12 of 417. All products under Mattress, Flotation Therapy, Non-Powered
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 |
|---|---|---|---|---|---|
| 2014-09-01 | Class II | Device Design | The firm received complaints regarding multiple mattresses were showing failures resulting in pressure ulcers. | 1,034 units | 2016-01-04 |
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.