FDA.reportPublic FDA data

Airisana

Primary DI
00609953768076
Brand
Airisana
Company
Encompass Group, L.L.C.
Model
ARSN--3680
Device description
"AIRISANA THRPTC SYSTEM 36""X80"" SURFACE AND UNIT SYSTEM, 36X80X9.25"
Published
2023-01-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
IKZBed, Patient Rotation, Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IKZBed, Patient Rotation, PoweredPhysical Medicine2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00609953768076PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00609953768076006099537680766099537680760609953768076

GMDN Terms#

Term, Definition table
TermDefinition
Flotation therapy bed, adultA mains electricity (AC-powered) bed designed to minimize pressure points on a patient's body by providing contact with as much of the body surface as possible, typically through a mattress that contains a large volume of constantly moving media, e.g., water, air, or mud that lifts the patient to simulate a floating effect. It is used in cases of decubitus ulcers or where a patient has little remaining body fat and the displacement of body weight is vital for treatment and/or comfort. It can also be used for the treatment badly burned patients and/or to aid circulation. The device may allow for the regulation of mattress temperature to enhance treatment.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-800-284-4540compliance@encompassgroup.net

Regulatory Flags#

DUNS number
121788819
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00612899045484EncompassVA550-252023-06-22
00612899101104EncompassVA550-25XB2023-06-22
20612899002726EncompassTP1002023-06-22
20612899004713EncompassG-P91532023-06-22
20612899004720EncompassG-P9163A2023-06-22
20612899005574EncompassG-P91642023-06-22
20612899005581EncompassG-P9165A2023-06-22
20612899005598EncompassG-P91662023-06-22
20612899005604EncompassG-P91512023-06-22
20612899005611EncompassG-P91522023-06-22
20612899005628EncompassG-P91542023-06-22
20612899005635EncompassG-P91552023-06-22
20612899005642EncompassG-P91562023-06-22
20612899005659EncompassG-P9161A2023-06-22
20612899005666EncompassG-P9162A2023-06-22
20612899005673EncompassG-P91642023-06-22
20612899005680EncompassP9165A2023-06-22
20612899005697EncompassP91662023-06-22
20612899005826EncompassG-P91502023-06-22
20612899005864EncompassG-P91602023-06-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00817012031850K-6 TURN-ZONEKAP MEDICALIKZ2026-01-16
00817012031829K-6oem AIRE-TURN ASSIST KAP MEDICALIKZ2025-10-10
00817012031843K-Zoem EZ-TURNKAP MEDICALIKZ2025-10-10
00817012031775K-6oem AIRE-TURN ASSIST KAP MEDICALIKZ2025-09-26
00817012031782K-6oem AIRE-TURN ASSIST KAP MEDICALIKZ2025-09-26
00817012031799K-6oem AIRE-TURN ASSIST KAP MEDICALIKZ2025-09-26
00817012031737K-6 TURN-ZONEKAP MEDICALIKZ2025-09-04
00817012022179K-Z ZM ZMattKAP MEDICALIKZ2025-06-27
00817012031676K-Zoem EZ-TURNKAP MEDICALIKZ2025-04-04
00817012031621K-6 AIRE-TURN ASSISTKAP MEDICALIKZ2024-11-22
00817012031638K-Z EZ-TURNKAP MEDICALIKZ2024-11-22
00817012031607K-Z Z-TURNKAP MEDICALIKZ2024-09-20
00817012031614K-Z Z-TURNKAP MEDICALIKZ2024-09-20
B414PAR3A3FXX0The Freedom BedProBed Medical Technologies IncIKZ2024-09-05
00817012031577K-Z ZM ZMattKAP MEDICALIKZ2024-08-23
00817012031584K-Zoem EZ-TURNKAP MEDICALIKZ2024-08-23
00817012031591K-Z ZM ZMattKAP MEDICALIKZ2024-08-23
00817012031492K-Z ZM ZMattKAP MEDICALIKZ2024-07-19
00817012031546K-Z Z-TURNKAP MEDICALIKZ2024-07-19
00860006962203Pronova-O2Turn Medical, LLCIKZ2024-06-03
00860011685609SideLyerTHE SIDE LYER COMPANY, LLCIKZ2024-04-29
00817012031355K-6 TURN-ZONEKAP MEDICALIKZ2024-01-19
00817012031362K-6 TURN-ZONEKAP MEDICALIKZ2024-01-19
00860004936817EasyShiftSeneca Devices, Inc.IKZ2024-01-12
00860004936848EasyShiftSeneca Devices, Inc.IKZ2024-01-12
00817012031386K-6 TURN-ZONEKAP MEDICALIKZ2023-11-30
00817012031379K-Z Z-TURNKAP MEDICALIKZ2023-08-11
00817012031348K-6 TURN-ZONEKAP MEDICALIKZ2023-07-14
00817012031164K-Z iTURNKAP MEDICALIKZ2023-06-02
00817012031171K-Z iTURNKAP MEDICALIKZ2023-06-02