FDA.reportPublic FDA data

Drive

Primary DI
00822383991757
Brand
Drive
Company
Drive Devilbiss Healthcare
Model
SFPRO317FS-12
Device description
"Spitfire Pro, 3-Wheel 17"" Seat, 12AH"
Published
2018-11-16
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
INIVEHICLE, MOTORIZED 3-WHEELED

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
INIVehicle, Motorized 3-WheeledPhysical Medicine2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K051473000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K051473000LEARDO, AVANTICARE ELECTRICAL SCOOTERSM3021Lerado China Limited2005-08-31INI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00822383991757PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00822383991757008223839917578223839917570822383991757

GMDN Terms#

Term, Definition table
TermDefinition
Assistive scooter, electric-motor-drivenA battery-powered, electric-motor-driven mobility device designed to be operated by a person with a disability and consisting of a seat over two rear wheels, a platform for the feet, and handlebars in front to turn one or two steerable front wheels connected via a steering-column. The device is used to enhance the user's ability for self-transportation in the local environment and/or to promote the user's physical/recreational activities.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
867673159
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00822383027180DECO, 5L Oxygen Concentrator5DECO2DS2026-10-29
00822383035482SIMO2, Portable Oxygen ConcentratorSIMO2DS2026-10-29
00822383036885SIMO2, Portable Oxygen Concentrator, Extended BatterySIMO2DS-EB2026-10-29
00023601061102Carex Health BrandsFGR11000 00002016-10-07
00092237614419Roscoe MedicalHUM-ROS62018-12-19
50050428250391DRIVEMEDICAL7417372019-06-21
00311917192352Walgreens9847282019-06-21
00822383989815DRIVEMEDICAL146-RTLPC23201-M2019-06-21
00822383989839DRIVEMEDICAL146-RTLPC23201-F2019-06-21
00822383246420DriveRTLPC23201-F2017-05-19
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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06973079880153SweetrichSUZHOU SWEETRICH VEHICLE INDUSTRY TECHNOLOGY CO., LTDINI2026-09-23
06973079880337SweetrichSUZHOU SWEETRICH VEHICLE INDUSTRY TECHNOLOGY CO., LTDINI2026-09-23
06973079880542Metro MobilitySUZHOU SWEETRICH VEHICLE INDUSTRY TECHNOLOGY CO., LTDINI2026-09-23
06973079880559Metro MobilitySUZHOU SWEETRICH VEHICLE INDUSTRY TECHNOLOGY CO., LTDINI2026-09-23
06973079880566Metro MobilitySUZHOU SWEETRICH VEHICLE INDUSTRY TECHNOLOGY CO., LTDINI2026-09-23
06973079880573Metro MobilitySUZHOU SWEETRICH VEHICLE INDUSTRY TECHNOLOGY CO., LTDINI2026-09-23
06973079880580Metro MobilitySUZHOU SWEETRICH VEHICLE INDUSTRY TECHNOLOGY CO., LTDINI2026-09-23
06973079880597Metro MobilitySUZHOU SWEETRICH VEHICLE INDUSTRY TECHNOLOGY CO., LTDINI2026-09-23
06973079880603Metro MobilitySUZHOU SWEETRICH VEHICLE INDUSTRY TECHNOLOGY CO., LTDINI2026-09-23
06973079880610Metro MobilitySUZHOU SWEETRICH VEHICLE INDUSTRY TECHNOLOGY CO., LTDINI2026-09-23
06973079880627Metro MobilitySUZHOU SWEETRICH VEHICLE INDUSTRY TECHNOLOGY CO., LTDINI2026-09-23
06973079880634Metro MobilitySUZHOU SWEETRICH VEHICLE INDUSTRY TECHNOLOGY CO., LTDINI2026-09-23
06973079880641Metro MobilitySUZHOU SWEETRICH VEHICLE INDUSTRY TECHNOLOGY CO., LTDINI2026-09-23
06973079880658Metro MobilitySUZHOU SWEETRICH VEHICLE INDUSTRY TECHNOLOGY CO., LTDINI2026-09-23
04713072963666FREERIDERFREERIDER CORP.INI2026-07-31
04713072963680FREERIDERFREERIDER CORP.INI2026-07-31
06973079880450IMOVESUZHOU SWEETRICH VEHICLE INDUSTRY TECHNOLOGY CO., LTDINI2026-07-20
00810226441118Vive MobilityVIVE HEALTH LLCINI2026-07-14
06973079880443TRAVEL BUGGYSUZHOU SWEETRICH VEHICLE INDUSTRY TECHNOLOGY CO., LTDINI2026-06-14
06973175531348MOGOAnhui JBH Medical Apparatus Co., Ltd.INI2026-05-09
06978949462149Mobility ScooterZhejiang Innuovo Rehabilitation Devices Co., LtdINI2026-04-29
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06978949463078Mobility ScooterZhejiang Innuovo Rehabilitation Devices Co., LtdINI2026-03-20
06978949463085Mobility ScooterZhejiang Innuovo Rehabilitation Devices Co., LtdINI2026-03-20
00606509300919Go Go Super Portable 2Pride Mobility Products CorpINI2026-03-19