FDA.report

DRIVEMEDICAL

Primary DI
00822383513348
Brand
DRIVEMEDICAL
Company
Drive Devilbiss Healthcare
Model
TITAN20CS
Device description
PowerPower Front Wheel Product Description: Titan K0821 FWD 20" x 18" Capt.Seat
Published
2016-07-01
Public version status
Update
Distribution status
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
00822383513348PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00822383513348008223835133488223835133480822383513348

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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00822383012186Silver Sport 18" Full ArmSSP18RBDFAV2026-02-03
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00822383033228AeroFly Transport Chair, 18", BlackAFT18BK-SF2025-11-11
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00822383000206Drive35MCBE-B-SC0535MCBE-B-SC052025-09-02
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