Aeda
This medical device is an Air Mattress, it is consist of a series of air cells which is used to support the patient when inflated, it is always used with an Air Pump, which is used to…
This medical device is an Air Mattress, it is consist of a series of air cells which is used to support the patient when inflated, it is always used with an Air Pump, which is used to control the Air Mattress Cells (air cells) to be inflated and deflated alternatively with a setting cycle time, and keep the Air Cells in a setting pressure value.
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 | Aeda Healthcare Limited |
|---|---|
| FDA product code | FNM |
| Device type | Mattress, Air Flotation, Alternating Pressure |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5550 |
| Premarket notification | Exempt |
| Record published | 2017-11-15 |
| Record revised | 2024-09-19 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Over the counter | Yes |
| Label carries | lot or batch number, serial number |
| Packaging | Big carton of 4 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 3M01M060041 Rev.C / MT-A3-025 | In distribution | |
| 1M01M060059 Rev.E / MT-S4-025 | In distribution | |
| 2M01M060022 Rev.B / MT-C4-231 | In distribution | |
| 2M01M060012 Rev.C / MT-S4-035 | In distribution | |
| 3M01M060021 Rev.E / MT-A3-021 | In distribution | |
| MT-A3-300 | In distribution | |
| 3M01M060023 | In distribution | |
| 3M01M060081 Rev.A / MT-A4-231 | In distribution | |
| 1M01M060037 Rev.C / CU-A2-155 | In distribution | |
| 3M01M060019 Rev.B / MT-A2-210 | In distribution | |
| MT-A3-301 | In distribution | |
| 2M01M060002 Rev.E / MT-S4-025 | 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-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 |
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.