FDA.report

DRIVEMEDICAL

Primary DI
00822383541990
Brand
DRIVEMEDICAL
Company
Drive Devilbiss Healthcare
Model
TITAN1618X23
Device description
PowerPower Front Wheel Product Description: Titan X23 K0823 FWD 16" x 18" Capt.Seat
Published
2016-07-01
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
INIVEHICLE, MOTORIZED 3-WHEELED
ITIWheelchair, powered

Product Code Classifications

CodeDeviceSpecialtyClass
INIVehicle, Motorized 3-WheeledPhysical Medicine2
ITIWheelchair, PoweredPhysical Medicine2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00822383541990PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00822383541990008223835419908223835419900822383541990

GMDN Terms

TermDefinition
Wheelchair, electric-motor-driven, occupant-controlled, powered-steering, collapsibleA wheeled personal mobility device that incorporates a seat-support system for a person with a disability or a person without the full capacity to walk (not bariatric) designed to be propelled by power from one or more electric motor(s). The electronic control of speed and direction are performed by the occupant of the device. The device may be disassembled or folded for transport.

Sterilization Methods

Method

Regulatory Flags

DUNS number
867673159
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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00822383012179Silver Sport 18" Det DeskSSP18RBDDAV2026-02-03
00822383012186Silver Sport 18" Full ArmSSP18RBDFAV2026-02-03
00822383012193Silver Sport 20" Det DeskSSP20RBDDAV2026-02-03
00822383012209Silver Sport 20" Full ArmSSP20RBDFAV2026-02-03
00822383034683Silver Sport HD 22"SSP22RBDDAV2026-02-03
00822383034690Silver Sport 24" HDSSP24RBDDAV2026-02-03
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00822383033228AeroFly Transport Chair, 18", BlackAFT18BK-SF2025-11-11
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00822383000206Drive35MCBE-B-SC0535MCBE-B-SC052025-09-02
00822383000213Drive35MCBE-A-SC0535MCBE-A-SC052025-09-02
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