FDA.reportPublic FDA data

Drive

Primary DI
00822383012117
Brand
Drive
Company
Drive Devilbiss Healthcare
Model
CP20N
Device description
Power Folding Power Product Description CirrusPlusPowerChair,20 FlpBkArm,1/ea
Published
2022-02-01
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
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
00822383012117PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00822383012117008223830121178223830121170822383012117

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
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
00023601012210Carex Health BrandsFGA22100 00002022-12-09
00023601012227CAREX HEALTH BRANDSFGA22200 00002022-12-12
00023601012234CAREX HEALTH BRANDSFGA22300 00002022-12-12
00023601012302CAREX HEALTH BRANDSFGA23000 00002022-12-12
00023601012319CAREX HEALTH BRANDSFGA23177 00002022-12-12
00023601012333CAREX HEALTH BRANDSFGA23300 00002022-12-12
00023601013330CAREX HEALTH BRANDSFGA33300 00002022-12-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
00606509300926Go Go Super Portable HDPride Mobility Products CorpINI2026-03-19
06974857293004Smarfody Electric ScooterDongguan Smarfody Mobility Technology Co., Ltd.INI2026-03-19
06974857293011Smarfody Electric ScooterDongguan Smarfody Mobility Technology Co., Ltd.INI2026-03-19
06974857293301Smarfody Electric ScooterDongguan Smarfody Mobility Technology Co., Ltd.INI2026-03-19
06974857293318Smarfody Electric ScooterDongguan Smarfody Mobility Technology Co., Ltd.INI2026-03-19
06974857295800Smarfody Electric ScooterDongguan Smarfody Mobility Technology Co., Ltd.INI2026-03-19
06978074600003MIJONanjing Mijo Technology Co., LtdINI2026-03-17
00810203611008ComfyGOComfyGO, IncINI2026-03-10
04719873857661KarmaKARMA MEDICAL PRODUCTS CO., LTD.INI2026-02-25
00606509300865Baja Wrangler 3Pride Mobility Products CorpINI2026-02-17
00606509300872Ultra X GEN 3Pride Mobility Products CorpINI2026-02-17
00606509300889Elite Traveller GEN 3Pride Mobility Products CorpINI2026-02-17
00606509300896Elite Traveller GEN 3 PlatinumPride Mobility Products CorpINI2026-02-17
06972665816002Nanjing Kangni Smart Technology Co., Ltd.Nanjing Kangni Smart Technology Co., Ltd.INI2026-02-11
06970990830694SolaxGuangdong Prestige Technology Co., Ltd.INI2026-01-08
06970990830700SolaxGuangdong Prestige Technology Co., Ltd.INI2026-01-08
06970990830717SolaxGuangdong Prestige Technology Co., Ltd.INI2026-01-08
06970990830724SolaxGuangdong Prestige Technology Co., Ltd.INI2026-01-08
06975185620173BaichenNINGBO BAICHEN MEDICAL DEVICES CO., LTDINI2026-01-07
04713072962379FREERIDERFREERIDER CORP.INI2026-01-02
04713072962386FREERIDERFREERIDER CORP.INI2026-01-02