FDA.reportPublic FDA data

Sizewise

Primary DI
00845699002658
Brand
Sizewise
Company
SIZEWISE RENTALS, L.L.C.
Model
ADP ROLAL3588
Device description
SW Rotate LAL Adapt (Alliance)
Published
2024-09-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
FNLBed, Ac-Powered Adjustable Hospital

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FNLBed, Ac-Powered Adjustable HospitalGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00845699002658PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00845699002658008456990026588456990026580845699002658

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

Regulatory Flags#

DUNS number
967025602
Device count
1
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00845699004942Mighty Rest Blower613550122026-05-08
00845699046430Agiliti - Essentia65-05-00002026-05-08
00845699046447Agiliti - Essentia65-05-00102026-05-08
00845699046454Agiliti - Capillaire CP-1020822026-05-08
00845699046461Agiliti - Capillaire CP-1018842026-05-08
00845699046478Agiliti - Capillaire CP-1023822026-05-08
00845699046485Agiliti - Capillaire CP-1023402026-05-08
00845699046492Agiliti - Capillaire CP-1020462026-05-08
00845699046515Agiliti - Capillaire CP-2033842026-05-08
00845699046522Agiliti - Capillaire CP-2026652026-05-08
00845699046539Agiliti - Capillaire CP-2026502026-05-08
00845699046546Agiliti - Capillaire 067-005-0102502026-05-08
00845699046386Agiliti HealthMedical Bed (FNL)2024-09-20
00845699008117Sizewise Manufacturing500601002024-09-20
00845699003525WOK4886-230V2024-09-13
00845699003730WOK5486-230V2024-09-13
00845699003747WOK6086-230V2024-09-13
00845699008124Sizewise Manufacturing500601502024-09-13
00845699004782Sizewise330605102024-08-30
00845699002238SizewiseBRP3 3948802024-08-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06972077023883CostcareXIAMEN ATLANTIS MFC CO.,LTDFNL2026-09-24
06972077024125CostcareXIAMEN ATLANTIS MFC CO.,LTDFNL2026-09-24
06972077024132CostcareXIAMEN ATLANTIS MFC CO.,LTDFNL2026-09-24
06972077024149CostcareXIAMEN ATLANTIS MFC CO.,LTDFNL2026-09-24
06972077024156CostcareXIAMEN ATLANTIS MFC CO.,LTDFNL2026-09-24
06972077024163CostcareXIAMEN ATLANTIS MFC CO.,LTDFNL2026-09-24
06972077024316CostcareXIAMEN ATLANTIS MFC CO.,LTDFNL2026-09-24
06972077024323CostcareXIAMEN ATLANTIS MFC CO.,LTDFNL2026-09-24
06972077025030CostcareXIAMEN ATLANTIS MFC CO.,LTDFNL2026-09-24
06972077025047CostcareXIAMEN ATLANTIS MFC CO.,LTDFNL2026-09-24
06972077025054CostcareXIAMEN ATLANTIS MFC CO.,LTDFNL2026-09-24
06972077025061CostcareXIAMEN ATLANTIS MFC CO.,LTDFNL2026-09-24
06972077025078CostcareXIAMEN ATLANTIS MFC CO.,LTDFNL2026-09-24
06972077025085CostcareXIAMEN ATLANTIS MFC CO.,LTDFNL2026-09-24
06975084500675AtlantisXIAMEN ATLANTIS MFC CO.,LTDFNL2026-09-24
06975084500682AtlantisXIAMEN ATLANTIS MFC CO.,LTDFNL2026-09-24
06975084500699AtlantisXIAMEN ATLANTIS MFC CO.,LTDFNL2026-09-24
06975084500705AtlantisXIAMEN ATLANTIS MFC CO.,LTDFNL2026-09-24
00841447197966INVACARE® DLX SERIES BED RAILINVACARE CORPORATIONFNL2026-09-22
00841447198048INVACARE® THINKSOFT® POSITIONING DEVICEINVACARE CORPORATIONFNL2026-09-22
06972077025191CostcareXIAMEN ATLANTIS MFC CO.,LTDFNL2026-09-19
06975084500071SPECIALTYXIAMEN ATLANTIS MFC CO.,LTDFNL2026-09-19
06975084500088DALTONXIAMEN ATLANTIS MFC CO.,LTDFNL2026-09-19
06975084500095CostcareXIAMEN ATLANTIS MFC CO.,LTDFNL2026-09-19
06975084500415SPECIALTYXIAMEN ATLANTIS MFC CO.,LTDFNL2026-09-19
06975084500422SPECIALTYXIAMEN ATLANTIS MFC CO.,LTDFNL2026-09-19
06975084500439SPECIALTYXIAMEN ATLANTIS MFC CO.,LTDFNL2026-09-19
06975084500446SPECIALTYXIAMEN ATLANTIS MFC CO.,LTDFNL2026-09-19
06975084500453SPECIALTYXIAMEN ATLANTIS MFC CO.,LTDFNL2026-09-19
06975084500460SPECIALTYXIAMEN ATLANTIS MFC CO.,LTDFNL2026-09-19