K-2 Kare-Zone
Alternating Pressure, On-Demand Low Air Loss, Auto Set, Auto Expandable Variable Length and Width, Automatic ON/OFF Bolster, Mattress System, 80"~85"~90" x 36"~42"~48" x 8".
52manufacturers in China registered for this device type
107catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangdong (18), Jiangsu (13), Fujian (10). 9 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Jiangsu Saikang Medical Equipment Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 34 |
| Foshan Hongfeng Co., Ltd. | Foshan | Guangdong | Contract manufacturer | 24 |
| Cofoe Medical Technology Co., Ltd. | Changsha | Hunan | Contract manufacturer | 22 |
| Jiangyin Newrise Medical Equipment Co., Ltd. | Jiangyin | Jiangsu | Contract manufacturer | 10 |
| Xiamen Senyang Co., Ltd. | Xiamen | Fujian | Contract manufacturer | 7 |
| SHL Healthcare Ltd. | Shenzhen | Guangdong | Contract manufacturer | 5 |
| Xiamen HOY Plastic Industrial Co., Ltd. | Xiamen | Fujian | Contract manufacturer | 5 |
| Apex Medical (Kunshan) Corp. | Kunshan | Jiangsu | Contract manufacturer | 4 |
| Shenzhen Fitconn Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 4 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Jiangsu NEW Pentastar Medical Products Co., Ltd. | Changzhou | Jiangsu | Exporter | 146 |
| Dragon Medical Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 48 |
Showing 12 of 52. All 52 manufacturers in China registered for Mattress, Air Flotation, Alternating Pressure
Record
| Listed by | KAP Medical, United States |
|---|---|
| FDA product code | FNM |
| Device type | Mattress, Air Flotation, Alternating Pressure |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5550 |
| Establishment | Contract manufacturer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2022-09-30 |
| Record revised | 2018-03-29 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| K-2-AVL-MS | In distribution | |
| K-2-AVL-MS-8 | In distribution | |
| K-2B-48-8 | In distribution | |
| K-2-EU-CON-XMS | In distribution | |
| K-2-AX-MS-8 | In distribution | |
| K-2B42-8 | In distribution | |
| K-2-EU-MS-8 | In distribution | |
| K-2-UK-ESB | In distribution | |
| K-2-B-MS-35-78-8 | In distribution | |
| K-2 | In distribution | |
| K-2SM-EU-VL-MS-8 | In distribution | |
| K-2ESB | In distribution | |
| K-2BMS | In distribution | |
| K-2-VL-MS-8 | In distribution | |
| K-2-EU-VL-MS-8 | In distribution | |
| K-2FBMS8 | In distribution | |
| K-2-UK-XMS | In distribution | |
| K-2B-54 | In distribution | |
| K-2B48 | In distribution | |
| K-2-CON-LM | In distribution | |
| K-2-UK-B42 | In distribution | |
| K-2B-54-8 | In distribution | |
| K-2-VL-MS | In distribution | |
| K-2-B-MS-ESB-6 | In distribution | |
| K-2-B-MS-6 | In distribution | |
| K-2-B-MS-FB-42-8 | In distribution | |
| K-2-UK-CON-B42 | In distribution | |
| K-2BB | In distribution | |
| K-2-EU-B48 | In distribution | |
| K-2ESB8 | In distribution | |
| K-2-B-MS-54-84-8 | In distribution | |
| K-2SM-EU-B48-8 | In distribution | |
| K-2-UK-RSB | In distribution | |
| K-2-EU-CON-B42 | In distribution | |
| K-2-B-MS-54-8 | In distribution | |
| K-2B39X84 | In distribution | |
| K-2-EU-UMS | In distribution | |
| K-2B-39-8 | In distribution | |
| K-2-B-MS-48-8 | In distribution | |
| K-2-EU-XMS | In distribution | |
| K-2-BB-AX-MS | In distribution | |
| K-2-B-MS-39-8 | In distribution | |
| K-2SM-EU-B42 | In distribution | |
| K-2STM | In distribution | |
| K-2-B | In distribution | |
| K-2SM-EU-RSB | In distribution | |
| K-2-UK-CON-XMS | In distribution | |
| K-2ESB84-8 | In distribution | |
| K-2-B-MS | In distribution | |
| K-2-EU-RSB | In distribution | |
| K-2-B-MS-FB-6 | In distribution | |
| K-2-UK-B42-8 | In distribution | |
| K-2B48X88 | In distribution | |
| K-2BMS42 | In distribution | |
| K-2COS | In distribution | |
| K-2-EU-CON-MS | In distribution | |
| K-2-UK-MS-8 | In distribution | |
| K-2RSBM | In distribution | |
| K-2-NS-AVL-MS | In distribution | |
| K-2B39 | In distribution | |
| K-2MS36X84 | In distribution | |
| K-2-UK-COS | In distribution | |
| K-2-EU-B42-8 | In distribution | |
| K-2FPMS | In distribution | |
| K-2-UK-CON-MS | In distribution | |
| K-2B48X84 | In distribution | |
| K-2FPMS8 | In distribution | |
| K-2-UK-B48 | In distribution | |
| K-2-B-MS-82-6 | In distribution | |
| K-2XMS | In distribution | |
| K-2SM-EU-B42-8 | In distribution | |
| K-2SM-EU-UMS | In distribution | |
| K-2SM-EU-B48 | In distribution | |
| K-2SM-EU-MS-8 | In distribution | |
| K-2-EU-COS | In distribution | |
| K-2-AX-MS | In distribution | |
| K-2UMS | In distribution | |
| K-2MS8 | In distribution | |
| K-2SM-EU-VL-MS | In distribution | |
| K-2B42 | In distribution | |
| K-2MS | In distribution | |
| K-2-EU-ESB | In distribution | |
| K-2-B-MS-FB-39-6 | In distribution | |
| K-2 220V | In distribution | |
| K-2-B-MS-ESB-39-8 | In distribution | |
| K-2-EU-VL-MS | In distribution | |
| K-2-CON-M | In distribution | |
| K-2-UK-B48-8 | In distribution | |
| K-2-EU-B42 | In distribution | |
| K-2SM-EU-MS | In distribution | |
| K-2-B-MS-39-9 | In distribution | |
| K-2-EU-MS | In distribution | |
| K-2-UK-MS | In distribution | |
| K-2-UK-UMS | In distribution | |
| K-2B39X88 | In distribution | |
| K-2-UK-CON-B48 | In distribution | |
| K-2FBMS | In distribution | |
| K-2-B-MS-42-8 | In distribution | |
| K-2-UK-VL-MS | In distribution | |
| K-2-UK-VL-MS-8 | In distribution | |
| K-2-B-MS-48-6 | In distribution | |
| K-2-EU-CON-B48 | In distribution | |
| K-2-EU-B48-8 | In distribution | |
| K-2-B-MS-8 | In distribution | |
| K-2RSB | In distribution | |
| K-2SM-EU-XMS | In distribution | |
| K-2-B-MS-39-84-8 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| PressureGuard | Span-America Medical Systems, Inc. | 328 |
| Span-America | Span-America Medical Systems, Inc. | 286 |
| Medline | Medline Industries, Inc. | 228 |
| K-2oem ALT-Aire + | KAP Medical | 130 |
| SenTech | Tridien Medical | 129 |
| Mattress, Air Flotation, Alternating Pressure | Carilex Medical, Inc. | 118 |
| K-4oem Aire-Float | KAP Medical | 90 |
| K-1oem ALT-Aire | KAP Medical | 72 |
| K-4 D³X | KAP Medical | 70 |
| Sizewise | Sizewise Rentals, L.L.C. | 68 |
| K-1 Derma-Kare | KAP Medical | 58 |
| Protekt Aire | Proactive Medical Products | 54 |
Showing 12 of 429. All products under Mattress, Air Flotation, Alternating Pressure
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.