ProForm
8 catalogue numbers from 2815, listed by Stryker GmbH, Switzerland, under Mattress, Flotation Therapy, Non-Powered. 30 manufacturers in China are registered for this product code.
30manufacturers in China registered for this device type
8catalogue numbers in this listing
5recalls on this code
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 | Stryker GmbH, Switzerland |
|---|---|
| FDA product code | IKY |
| Device type | Mattress, Flotation Therapy, Non-Powered |
| Device class | Class 1 |
| Regulation | 21 CFR 880.5150 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2019-05-17 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number, serial number |
| Storage | Storage environment humidity 10 to 95 % RH; Handling environment humidity 10 to 95 % RH; Handling environment temperature -40 to 60 °C; Storage environment atmospheric pressure 50 to 106 KiloPascal; Handling environment atmospheric pressure 50 to 106 KiloPascal; Storage environment temperature -40 to 60 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 2815 | In distribution | |
| 2815 | In distribution | |
| 2815 | In distribution | |
| 2815 | In distribution | |
| 2815 | In distribution | |
| 2815 | In distribution | |
| 2815 | In distribution | |
| 2815 | In distribution |
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
4 of these are 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 |
|---|---|---|---|---|---|
| 2021-05-12 | Class II | Under Investigation by firm | Medical devices intended for use in a healthcare facility were distributed to residential customers and may be in use in a home environment. The product s labeling accurately identifies the correct use environment, but home users may not b | 3 units | |
| 2021-05-12 | Class II | Under Investigation by firm | Medical devices intended for use in a healthcare facility were distributed to residential customers and may be in use in a home environment. The product s labeling accurately identifies the correct use environment, but home users may not b | 3 units | |
| 2021-05-12 | Class II | Under Investigation by firm | Medical devices intended for use in a healthcare facility were distributed to residential customers and may be in use in a home environment. The product s labeling accurately identifies the correct use environment, but home users may not b | 1 unit | |
| 2020-08-12 | Class II | Nonconforming Material/Component | Connector between support surface and pump may be out of tolerance resulting in difficulty in removing the CPR connector causing a delay in resuscitation efforts for patients experiencing cardiac arrest and needing CPR | 110 units | 2021-04-02 |
| 2011-04-29 | Not classified | Other | Affected mattresses may not conform to federal flammability standards. | 213 | 2011-10-07 |
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.