FDA.reportPublic FDA data

Drive

Primary DI
00822383007533
Brand
Drive
Company
Drive Devilbiss Healthcare
Model
CP18N
Device description
Power Folding Power Product Description CirrusPlusPowerChair,18 FlpBkArm,1/ea
Published
2022-02-01
Public version status
Update
Distribution status
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
K062676000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K062676000RUIKE, MODEL 3331Shanghai Ruike Sports Goods Co., Ltd.2006-12-14INI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00822383007533PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00822383007533008223830075338223830075330822383007533

GMDN Terms#

Term, Definition table
TermDefinition
Wheelchair, electric-motor-driven, attendant/occupant-controlled, powered-steering, non-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 may be performed by an attendant or the occupant. The device cannot be folded or readily dismantled for transport.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
867673159
Device count
1
DM exempt
true
Serial number
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
00009223761941EswallowESW-90502016-12-31
00023601005144CAREX HEALTH BRANDSFGA51400 00002022-12-20
00023601005151CAREX HEALTH BRANDSFGA51500 BLUE2022-12-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00606509300933Go Go Super Portable 2Pride Mobility Products CorpINI2026-10-23
06973079880139SweetrichSUZHOU SWEETRICH VEHICLE INDUSTRY TECHNOLOGY CO., LTDINI2026-09-23
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
06978746860155Mobility scooter for disabled and elderlyZhejiang Wei Ling New Energy Technology Co., Ltd.INI2026-04-09
06978746860162Mobility scooter for disabled and elderlyZhejiang Wei Ling New Energy Technology Co., Ltd.INI2026-04-09
06978949462507Mobility ScooterZhejiang Innuovo Rehabilitation Devices Co., LtdINI2026-03-20
06978949463061Mobility ScooterZhejiang Innuovo Rehabilitation Devices Co., LtdINI2026-03-20
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