FDA.reportPublic FDA data

KD

Primary DI
06970575220186
Brand
KD
Company
SUZHOU KD INTELLIGENT DEVICE CO., LTD
Model
PL001-8000
Published
2024-08-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
ITIWheelchair, Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ITIWheelchair, PoweredPhysical Medicine2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K113463000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K113463000POWER WHEELCHAIRSuzhou KD Medical Appliance Co., Ltd.2012-04-06ITI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06970575220186PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06970575220186069705752201866970575220186

GMDN Terms#

Term, Definition table
TermDefinition
Electric-motor-driven wheelchair, occupant-controlledAn electrically-powered wheeled personal mobility device with a seat designed to enable a non-bariatric person with a disability, or without the full capacity to walk, to self-mobilize using power from an electric motor(s). It includes controls (typically joystick) to allow the occupant electronic control of speed/direction; it is not designed with a foot platform and handlebars (i.e., not a mobility scooter).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
544250984
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06970575220988Travel BuggyPL001-90012025-11-25
06970575220018KDPL0012024-08-13
06970575220025KDPL001-10002024-08-13
06970575220032KDPL001-20002024-08-13
06970575220049KDPL001-30002024-08-13
06970575220056KDPL001-40002024-08-13
06970575220063KDPL001-50002024-08-13
06970575220070KDPL001-60002024-08-13
06970575220131KDPL001-70002024-08-13
06970575220087KDPL001-80022024-05-14
06970575220094KDPL001-20032024-05-14
06970575220100KDPL001-20102024-05-14
06970575220117KDPL001-20042024-05-14
06970575220124KDPL001-30032024-05-14
06970575220148KDPL001-70022024-05-14
06970575220155KDPL001-70032024-05-14
06970575220162KDPL001-40012024-05-14
06970575220179KDPL001-30052024-05-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06974842140160RobooterShanghai Bangbang Robotics Co.,Ltd.ITI2026-07-24
06974842140177RobooterShanghai Bangbang Robotics Co.,Ltd.ITI2026-07-24
06974842140504Robooter E60Shanghai Bangbang Robotics Co.,Ltd.ITI2026-07-24
06974842140566RobooterShanghai Bangbang Robotics Co.,Ltd.ITI2026-07-24
06974842140580Robooter E60Shanghai Bangbang Robotics Co.,Ltd.ITI2026-07-24
06974842140641Robooter E60Shanghai Bangbang Robotics Co.,Ltd.ITI2026-07-24
06974842140665Robooter E60Shanghai Bangbang Robotics Co.,Ltd.ITI2026-07-24
06974842140726Robooter E60Shanghai Bangbang Robotics Co.,Ltd.ITI2026-07-24
06974842140740Robooter E60Shanghai Bangbang Robotics Co.,Ltd.ITI2026-07-24
06974842142102RobooterShanghai Bangbang Robotics Co.,Ltd.ITI2026-07-24
06974842142119RobooterShanghai Bangbang Robotics Co.,Ltd.ITI2026-07-24
06974842142126RobooterShanghai Bangbang Robotics Co.,Ltd.ITI2026-07-24
06974842142140RobooterShanghai Bangbang Robotics Co.,Ltd.ITI2026-07-24
06974842142072Electric WheelchairShanghai Bangbang Robotics Co.,Ltd.ITI2026-07-23
06974842142089Electric WheelchairShanghai Bangbang Robotics Co.,Ltd.ITI2026-07-23
06974842142096Electric WheelchairShanghai Bangbang Robotics Co.,Ltd.ITI2026-07-23
06974842142133RobooterShanghai Bangbang Robotics Co.,Ltd.ITI2026-07-23
06974842141693Electric WheelchairShanghai Bangbang Robotics Co.,Ltd.ITI2026-07-07
06974665661095EldHilfeYongkang Youha Electric Appliance Co.,LtdITI2026-06-24
06977027831099CHINFREANZhejiang Nysin Medical Co.,LtdITI2026-06-23
06973175531430MOGOAnhui JBH Medical Apparatus Co., Ltd.ITI2026-05-30
00860015909206VeloxVelox Manufacturing IncITI2026-05-28
06973134773017sliverfoxSilverfox Corporation LimitedITI2026-05-27
04046727184476e-motion®Alber GmbHITI2026-05-26
04046727184483e-motion®Alber GmbHITI2026-05-26
04046727184490e-motion®Alber GmbHITI2026-05-26
04046727248994e-fix®Alber GmbHITI2026-05-26
04046727250928e-fix®Alber GmbHITI2026-05-26
04046727250935e-fix®Alber GmbHITI2026-05-26
04046727250942e-fix®Alber GmbHITI2026-05-26