FDA.reportPublic FDA data

DRIVEMEDICAL

Primary DI
50311917171291
Brand
DRIVEMEDICAL
Company
Drive Devilbiss Healthcare
Model
369351
Device description
Pressure PreventionRetail Foam Product Description: Lumbar Cushion W/Straps14x13.5,1/ea,4/cs
Published
2019-06-21
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
IMPCUSHION, WHEELCHAIR
IQEORTHOSIS, LUMBAR

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IMPCushion, WheelchairPhysical Medicine1
IQEOrthosis, LumbarPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00311917171296PackageGS14Not in Commercial Distribution
50311917171291PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00311917171296003119171712963119171712960311917171296
5031191717129150311917171291

GMDN Terms#

Term, Definition table
TermDefinition
Lumbar cushionA soft pillow or pad used to provide support and comfort to the user's lower back, often during the treatment and/or prevention of musculoskeletal disorders or injuries. The device may be used to support the natural curvature of the lower spine, improve posture, relax muscles, and relieve painful pressure points. The device is typically placed between the lower back and the back of a seat/chair while the user is seated.

Regulatory Flags#

DUNS number
867673159
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00822383037127Silver SportBIN-SSP316DDA-SF2026-06-22
00822383037134Silver SportBIN-SSP218DDA-SF2026-06-22
00822383037141Silver SportBIN-SSP220DDA-SF2026-06-22
00822383037158Cruiser 3 16"BIN-K316ADDA-SF2026-06-22
00822383037165Cruiser 3 18"BIN-K318ADDA-SF2026-06-22
00822383037172Cruiser 3 20"BIN-K320ADDA-SF2026-06-22
00194346283439EquateEQKW5002026-06-10
10092237600105Roscoe MedicalEP4070WCD2016-10-18
90002360125501AccuReliefACRL-55002016-10-12
00009223761699Reliable MedicalEF2020BC2-TU2018-06-13
00009223761941EswallowESW-90502016-12-31
00023601005144CAREX HEALTH BRANDSFGA51400 00002022-12-20
00023601005151CAREX HEALTH BRANDSFGA51500 BLUE2022-12-20
00023601005168CAREX HEALTH BRANDSFGA51600 GRN2022-12-20
00023601005175CAREX HEALTH BRANDSFGA51700 BRNZ2022-12-20
00023601005182CAREX HEALTH BRANDSFGA51800 GRAY2022-12-20
00023601007117CAREX HEALTH BRANDSFGA71100 00002023-03-15
00023601007179CAREX HEALTH BRANDSFGA71700 00002023-03-15
00023601007186CAREX HEALTH BRANDSFGA71800 00002023-03-15
00023601007193CAREX HEALTH BRANDSFGA71900 00002023-03-15

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Primary DI, Brand, Company table
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