FDA.reportPublic FDA data

WOK

Primary DI
00845699003808
Brand
WOK
Company
WHEELCHAIRS OF KANSAS
Model
12060309
Device description
230V Mighty Rest 39-80 Full Electric Inti. P/N 12060309 and 230V Mighty Rest 39-80 Full Electric P/N 12060000
Published
2024-09-13
Public version status
Update
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
00845699003808PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00845699003808008456990038088456990038080845699003808

GMDN Terms#

Term, Definition table
TermDefinition
Bariatric bedA mains electricity (AC-powered) bed specifically designed as a bed to accommodate a bariatric (obese) patient whose body mass exceeds the safe working load of standard hospital/institution beds and trolleys, i.e., 500 kg total, including the weight of the mattress and other accessories. Features like size, shape, and patient comfort (both physical and mental) will be taken into consideration by the design. This device is electrically-operated to assist the user/attending staff to adjust the functions and positions of the bed. It will typically include adjustable height, back rest, knee-break, removable head and foot ends and possibly an integrated weighing facility.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
063402450
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
00845699003822Mighty Rest 12060310 230V2026-05-08
00845699003723WOK6080-230V2024-09-20
00845699003501WOK4880-230V2024-09-13
00845699003518WOK3986-230V2024-09-13
00845699003792WOK120603092024-09-13
00845699003815WOK120603102024-09-14
00845699003839WOK3980-230V2024-09-13
00845699004768WOK330603002024-08-30
00845699003532WOK230600102024-09-13
00845699003549WOK230602102024-09-13
00845699003556WOK230602202024-09-13
00845699003563WOK230600402024-09-13
00845699003570WOK180600002024-09-13
00845699003587WOK180600102024-09-13
00845699003495WOK3980-230V2024-09-13
00845699003631WOK616000602024-09-13
00845699003846WOK3580-115V2024-09-13
00845699003877WOK4280-230V2024-09-13
00845699003884WOK4286-230V2024-09-13
00845699003891WOK4286-115V2024-09-13

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