FDA.reportPublic FDA data

Air Comfort

Primary DI
09343062033656
Brand
Air Comfort
Company
K CARE HEALTHCARE SOLUTIONS PTY LTD
Model
AC59214
Published
2025-03-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
FRJChair, Geriatric

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FRJChair, GeriatricGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09343062033656PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09343062033656093430620336569343062033656

GMDN Terms#

Term, Definition table
TermDefinition
Flotation therapy chairA mains electricity (AC-powered) specialized device designed to support a patient in a seated position and minimize pressure points on the patient's body. This is achieved by creating chair contact with as much of the body surface as possible, typically through a series of inflated cushions that simultaneously lift the patient and simulate floating. 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
746978279
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
09343062022322Air ComfortAC594412025-03-13
09343062029642Air ComfortAC591112025-03-13
09343062029666Air ComfortAC591122025-03-13
09343062031980Air ComfortAC591142025-03-13
09343062031997Air ComfortAC591162025-03-13
09343062032147Air ComfortAC591152025-03-13
09343062033465Air ComfortAC592112025-03-13
09343062033571Air ComfortAC592162025-03-13
09343062036343Air ComfortAC592152025-03-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
09343062022322Air ComfortK CARE HEALTHCARE SOLUTIONS PTY LTDFRJ2025-03-13
09343062029642Air ComfortK CARE HEALTHCARE SOLUTIONS PTY LTDFRJ2025-03-13
09343062029666Air ComfortK CARE HEALTHCARE SOLUTIONS PTY LTDFRJ2025-03-13
09343062031980Air ComfortK CARE HEALTHCARE SOLUTIONS PTY LTDFRJ2025-03-13
09343062031997Air ComfortK CARE HEALTHCARE SOLUTIONS PTY LTDFRJ2025-03-13
09343062032147Air ComfortK CARE HEALTHCARE SOLUTIONS PTY LTDFRJ2025-03-13
09343062033465Air ComfortK CARE HEALTHCARE SOLUTIONS PTY LTDFRJ2025-03-13
09343062033571Air ComfortK CARE HEALTHCARE SOLUTIONS PTY LTDFRJ2025-03-13
09343062036343Air ComfortK CARE HEALTHCARE SOLUTIONS PTY LTDFRJ2025-03-13
06975821401111UnixcareJiangyin Unixcare Medical Devices Co.,LtdFRJ2022-11-23
00853223008380MEDACUREMEDACURE INC.FRJ2020-10-01
00815027010587DALTON GERIATRIC RECLINERDALTON MEDICAL CORPORATIONFRJ2019-06-11
00815027010594DALTON GERIATRIC RECLINERDALTON MEDICAL CORPORATIONFRJ2019-06-11
00815027010600DALTON CLINICAL RECLINERDALTON MEDICAL CORPORATIONFRJ2019-06-11
00855630004085WincoWINCO MFG., LLCFRJ2018-12-07
00855630004092WincoWINCO MFG., LLCFRJ2018-12-07
00855630004108WincoWINCO MFG., LLCFRJ2018-12-07
00855630004115WincoWINCO MFG., LLCFRJ2018-12-07
00855630004122WincoWINCO MFG., LLCFRJ2018-12-07
00855630004139WincoWINCO MFG., LLCFRJ2018-12-07
00855630004146WincoWINCO MFG., LLCFRJ2018-12-07
00855630004153WincoWINCO MFG., LLCFRJ2018-12-07
00855630004160WincoWINCO MFG., LLCFRJ2018-12-07
00855630004177WincoWINCO MFG., LLCFRJ2018-12-07
00855630004184WincoWINCO MFG., LLCFRJ2018-12-07
00855630004191WincoWINCO MFG., LLCFRJ2018-12-07
00855630004207WincoWINCO MFG., LLCFRJ2018-12-07
00855630004214WincoWINCO MFG., LLCFRJ2018-12-07
00855630004221WincoWINCO MFG., LLCFRJ2018-12-07
00855630004238WincoWINCO MFG., LLCFRJ2018-12-07