Airisana

Airisana Thrptc System 42"X80" Surface AND Unit System, 42X80X9.25

Registry build 21.09.26
1manufacturer
7catalogue numbers in this listing

Who Else Makes It

Registered in Zhejiang.

Chinese manufacturers registered for FDA product code IKZ
Manufacturer City Province Registered as Device types
Ningbo Kangmailong Medical Apparatus Co., Ltd. Cixi City, Ningbo Zhejiang Contract manufacturer 10

Record

Regulatory record for Airisana
Listed by Encompass Group, L.L.C.
FDA product code IKZ
Device type Bed, Patient Rotation, Powered
Device class Class 2
Regulation 21 CFR 890.5225
Premarket notification Exempt
Record published 2023-01-20
Record revised 2023-05-05 (version 2)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Prescription Prescription only
Label carries lot or batch number, manufacturing date, serial number

Catalogue Numbers

Catalogue numbers for Airisana
Catalogue number Size Status
ARSN–4280 In distribution
ARSN–4880 In distribution
ARSN–CTL In distribution
ARSN–4884 In distribution
ARSN–3680 In distribution
ARSN–4284 In distribution
ARSN–3684 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Hill-Rom Tridien Medical 88
K-Z Z-Turn KAP Medical 59
K-6 Turn-Zone KAP Medical 51
K-6oem Aire-Turn Assist KAP Medical 43
K-Zoem EZ-Turn KAP Medical 41
K-6oem Aire-Turn KAP Medical 14
SenTech Tridien Medical 9
K-6oemFAMS KAP Medical 8
The Freedom Bed Probed Medical Technologies, Inc. 7
K-Z iTURN KAP Medical 6
K-Z EZ-Turn KAP Medical 4
K-Z ZM ZMatt KAP Medical 4

Showing 12 of 22. All products under Bed, Patient Rotation, Powered

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