K-4oem Aire-Float

Alternating Pressure, Low Air Loss, Extension/Expansion Expandable Mattress System, 80"~85"~90"x 36"~42"~48"x8", with EU Power Cord.

Registry build 21.09.26
52manufacturers in China registered for this device type
90catalogue 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.

Chinese manufacturers registered for FDA product code FNM
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

Regulatory record for K-4oem Aire-Float
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 2016-09-19
Record revised 2018-03-29 (version 2)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Label carries expiry date, manufacturing date, serial number

Catalogue Numbers

Catalogue numbers for K-4oem Aire-Float
Catalogue number Size Status
K-4oemB42RSBSAC In distribution
K-4-UK-VL-MS-8 In distribution
K-4oem-EU-VL-MS In distribution
K-4oemMS In distribution
K-4oemMS76 In distribution
MATRIX-ALALMS42X8 In distribution
K-4oemB60RSBSAC In distribution
K-4oemB48 In distribution
K-4oemMS36X84 In distribution
K-4oem36X84RSBSAC In distribution
K-4oemB42X84RSBSAC In distribution
K-4oemB60 In distribution
K-4oemUHSB54 In distribution
K-4oemB42 In distribution
K-4oemFRSB48 In distribution
K-4oemUHSCOS In distribution
K-4oem-EU-B42 In distribution
K-4oemB48X84RSB In distribution
K-4oem 220V In distribution
K-4oem-EU-VL-MS-8 In distribution
K-4oemB42X84 In distribution
K-4oem-UK-MS In distribution
K-4oemB54 In distribution
K-4oemB48X84 In distribution
K-4oem-UK-ESB In distribution
K-4oemB39X84RSBSAC In distribution
K-4oemCOS In distribution
K-4oem-EU-FP-MS In distribution
K-4oemRSB In distribution
K-4oemUHSMS8 In distribution
K-4oemUHSB42 In distribution
K-4oem-UK-FP-MS In distribution
K-4oem-EU-X-MS-D-8 In distribution
K-4oemUHSB39 In distribution
K-4oem-EU-UMS In distribution
K-4oem-UK-COS In distribution
K-4oemUHSB48 In distribution
K-4oem-VL-MS In distribution
K-4oemUHSMS In distribution
K-4oemMS8 In distribution
K-4oemB42X8 In distribution
K-4oem-UK-RSB In distribution
K-4oem-EU-COS In distribution
K-4oemRSB39X84 In distribution
K-4oemMS36X84SAC In distribution
K-4oem-UK-FP-MS-8 In distribution
K-4oemXMS In distribution
K-4oem-VL-MS-8 In distribution
K-4oemB54X84RSBSAC In distribution
K-4oemMS7X84 In distribution
K-4oemUHS88MS8EL In distribution
K-4oemRSBSAC In distribution
K-4oem-UK-B48-8 In distribution
K-4oem-EU-B48-8 In distribution
K-4oem-UK-B42-8 In distribution
K-4oem-EU-B42-8 In distribution
K-4oem-EU-MS-8 In distribution
K-4oem-EU-B48 In distribution
K-4oemMS84 In distribution
K-4oem-EU-RSB In distribution
K-4oemMS7 In distribution
K-4oem-UK-B42 In distribution
K-4oemB39RSBSAC In distribution
MATRIX-ALALMS8 In distribution
K-4oem-UK-VL-MS In distribution
K-4oem-UK-UMS In distribution
K-4oem-EU-FP-MS-8 In distribution
K-4oem-FP-MS In distribution
K-4oem-UK-VL-MS-8 In distribution
K-4oemUMS In distribution
K-4oemUHSXM In distribution
K-4oemB48X84RSBSAC In distribution
K-4oemB60X84RSBSAC In distribution
K-4oemB39 In distribution
K-4oem-EU-ESB In distribution
K-4oem-UK-B48 In distribution
K-4oem-UK-XMS In distribution
K-4oemB48RSBSAC In distribution
K-4oemB54RSBSAC In distribution
K-4oem In distribution
K-4oem-UK-MS-8 In distribution
K-4oem-ESB In distribution
K-4oemUHSCOS3 In distribution
K-4oemB42X84X10RSBSAC In distribution
MATRIX-ALALMS8X84 In distribution
K-4oem-EU-MS In distribution
K-4oemB39X84 In distribution
K-4oemUHSMS In distribution
K-4oem-B48-8 In distribution
K-4oem-EU-XMS In distribution

Same Product Code

Other products under the same FDA 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-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.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer