Mattress, Air Flotation, Alternating Pressure
Envelop Cover 35.5'' × 83'' BIG CPR DTX Carilex-1p
52manufacturers in China registered for this device type
118catalogue 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 | Carilex Medical, Inc., Taiwan |
|---|---|
| FDA product code | FNM |
| Device type | Mattress, Air Flotation, Alternating Pressure |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5550 |
| Establishment | Contract manufacturer, Private-label distributor, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2017-03-22 |
| Record revised | 2018-09-18 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number, manufacturing date, serial number |
| Packaging | Pack of 10, pack of 5, pack of 6, pack of 50 |
| Distribution end date | 2018-10-03 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| S2201-2170 | In distribution | |
| S2106-3161 | In distribution | |
| S2509-A020 | In distribution | |
| S2106-2010 | In distribution | |
| S2101-3071 | In distribution | |
| S2101-A590 | In distribution | |
| S2101-A110 | In distribution | |
| S2101-3011 | In distribution | |
| S2509-7040 | In distribution | |
| S2001-2460 | In distribution | |
| S2509-A070 | In distribution | |
| S2203-A010 | In distribution | |
| S2202-2220 | In distribution | |
| S2101-2210 | In distribution | |
| S2202-2530 | In distribution | |
| S2202-2540 | In distribution | |
| S2509-7130 | In distribution | |
| S2003-A210 | In distribution | |
| S2203-2040 | In distribution | |
| S2003-2260 | In distribution | |
| S2109-2030 | In distribution | |
| S2202-3181 | In distribution | |
| S2002-3101 | In distribution | |
| S2109-A010 | In distribution | |
| S2202-2570 | In distribution | |
| S2509-7050 | In distribution | |
| S2003-A170 | In distribution | |
| S2203-3021 | In distribution | |
| S2509-A050 | In distribution | |
| S2509-A030 | In distribution | |
| S2106-3111 | In distribution | |
| S2503-A060 | In distribution | |
| S2003-A220 | In distribution | |
| S2202-2580 | In distribution | |
| S2101-2510 | In distribution | |
| S2202-2550 | In distribution | |
| S2509-7120 | In distribution | |
| S2203-2170 | In distribution | |
| S2101-A600 | In distribution | |
| S2103-A050 | In distribution | |
| S2509-A010 | In distribution | |
| S2203-3011 | In distribution | |
| S2003-A130 | In distribution | |
| S2001-A521 | In distribution | |
| S2003-A310 | In distribution | |
| S2507-7062 | In distribution | |
| S2101-A380 | In distribution | |
| S2101-2290 | In distribution | |
| S2103-2070 | In distribution | |
| S2101-A610 | In distribution | |
| S2503-A050 | In distribution | |
| S2109-2040 | In distribution | |
| S2101-2500 | In distribution | |
| S2201-2020 | In distribution | |
| S2101-A580 | In distribution | |
| S2509-A040 | In distribution | |
| S2002-3091 | In distribution | |
| S2101-A300 | In distribution | |
| S2304-3012 | In distribution | |
| S2509-7060 | In distribution | |
| S2109-A030 | In distribution | |
| S2503-A030 | In distribution | |
| S2202-2560 | In distribution | |
| S2003-A300 | In distribution | |
| S2101-3021 | In distribution | |
| S2003-2100 | In distribution | |
| S2201-3071 | In distribution | |
| S2203-A190 | In distribution | |
| S2101-2530 | In distribution | |
| S2509-A060 | In distribution | |
| S2101-A130 | In distribution | |
| S2509-7170 | In distribution | |
| S2101-A120 | In distribution | |
| S2101-A310 | In distribution | |
| S2109-3011 | In distribution | |
| S2509-7020 | In distribution | |
| S2003-A160 | In distribution | |
| S2003-A140 | In distribution | |
| S2101-2490 | In distribution | |
| S2109-A020 | In distribution | |
| S2101-A570 | In distribution | |
| S2106-A010 | In distribution | |
| S2003-2080 | In distribution | |
| S2109-2020 | In distribution | |
| S2203-A020 | In distribution | |
| S2203-2030 | In distribution | |
| S2003-2140 | In distribution | |
| S2101-2520 | In distribution | |
| S2002-7150 | In distribution | |
| S2003-2250 | In distribution | |
| S2003-3042 | In distribution | |
| S2509-7010 | In distribution | |
| S2203-3121 | In distribution | |
| S2509-7110 | In distribution | |
| S2101-A620 | In distribution | |
| S2101-2130 | In distribution | |
| S2509-A100 | In distribution | |
| S2101-2390 | In distribution | |
| S2109-A040 | In distribution | |
| S2201-3051 | In distribution | |
| S2109-2010 | In distribution | |
| S2503-A040 | In distribution | |
| S2101-2100 | In distribution | |
| S2101-2090 | In distribution | |
| S2201-2140 | In distribution | |
| S2101-2540 | In distribution | |
| S2003-2150 | In distribution | |
| S2509-7030 | Withdrawn | |
| S2201-2470 | Withdrawn | |
| S2509-7070 | Withdrawn | |
| S2002-3061 | Withdrawn | |
| S2001-A460 | Withdrawn | |
| S2509-7100 | Withdrawn | |
| S2509-7090 | Withdrawn | |
| S2509-7080 | Withdrawn | |
| S2903-0031 | Withdrawn | |
| S2101-A260 | Withdrawn | |
| S2201-A160 | Withdrawn |
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 |
| K-2 Kare-Zone | KAP Medical | 107 |
| 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.