Protekt Aire

Protekt Aire 6000 Low Air Loss / Alternating Pressure Mattress System w/ Twist Style CPR Release w/ Deluxe Digital Pump and Cell-On-Cell Support Base 36"x80"x8", w/ Extended Hose

Registry build 21.09.26
52manufacturers in China registered for this device type
54catalogue 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 Protekt Aire
Listed by Proactive Medical Products, United States
FDA product code FNM
Device type Mattress, Air Flotation, Alternating Pressure
Device class Class 2
Regulation 21 CFR 880.5550
Establishment Repacker / relabeller, Complaint-file establishment
Premarket notification Exempt
Record published 2016-08-12
Record revised 2025-12-19 (version 3)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Label carries lot or batch number, manufacturing date, serial number
Sizes Length 18 to 84 in; width 5 to 69 in; height 2 to 10 in
Distribution end date 2025-12-18

Catalogue Numbers

Catalogue numbers for Protekt Aire
Catalogue number Size Status
80085 Length 80 in In distribution
85050-48 Length 80 in In distribution
80040 Width 36 in In distribution
80010 Height 2 in In distribution
80025 Length 80 in In distribution
86400 Length 80 in In distribution
80030 Width 36 in In distribution
80070-48 Length 80 in In distribution
81090-60 Height 10 in In distribution
80018 Height 3 in In distribution
85050-42 Length 80 in In distribution
80050 Width 36 in In distribution
80012 Height 2 in In distribution
80090 Height 10 in In distribution
80070 Length 84 in In distribution
80080 Length 80 in In distribution
80080-84 Height 10 in In distribution
80089 Length 80 in In distribution
81090-36 Length 80 in In distribution
80085-84 Length 84 in In distribution
80050 Height 6 in In distribution
80040 Length 80 in In distribution
80020 Width 36 in In distribution
86450 Height 6 in In distribution
81090-36B Height 10 in In distribution
84600 Length 80 in In distribution
80065 Length 80 in In distribution
81090-54 Length 80 in In distribution
80060-PRG Length 80 in In distribution
80066 Height 6 in In distribution
81090-P Length 18 in In distribution
80060 Width 36 in In distribution
81090-42 Length 80 in In distribution
81090-48 Height 10 in In distribution
83500 Length 80 in In distribution
85050 Length 80 in In distribution
80080-60 Height 10 in In distribution
86082AB-42 Height 10 in In distribution
86082AB-48 Length 80 in In distribution
80019 Length 24 in In distribution
80070-42 Length 84 in In distribution
80005 Width 35 in In distribution
80080-54 Length 80 in In distribution
83600 Length 80 in In distribution
86082AB Length 80 in In distribution
80011 Width 35 in In distribution
94001 Width 36 in Withdrawn
94003 Height 7 in Withdrawn
83500 Height 6 in Withdrawn
94004 Height 7 in Withdrawn
83600 Length 80 in Withdrawn
84600 Height 6 in Withdrawn
81090-48B Height 10 in Withdrawn
81090-42B Length 80 in Withdrawn

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-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.

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