FDA.reportPublic FDA data

Electric Wheelchair(Robooter E60)

Primary DI
06974842140634
Brand
Electric Wheelchair(Robooter E60)
Company
Shanghai Bangbang Robotics Co.,Ltd.
Model
BBR-E60-01
Device description
Gray Front
Published
2024-07-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
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
K240339000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K240339000Electric Wheelchair (Robooter E60) (BBR-E60-01); Electric Wheelchair (Robooter E60) (BBR-E60-02); Electric Wheelchair (Robooter E60) (BBR-E60-03); Electric Wheelchair (Robooter E60) (BBR-E60-04); Electric Wheelchair (Robooter E60) (BBR-E60-05); Electric Wheelchair (Robooter E60) (BBR-E60-06); Electric Wheelchair (Robooter E60) (BBR-E60-07); Electric Wheelchair (Robooter E60) (BBR-E60-08)Shanghai Bangbang Robotics Co., Ltd.2024-07-22ITI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06974842140634PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06974842140634069748421406346974842140634

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
544486463
Device count
1
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
06974842140160RobooterBBR-E40-012026-07-24
06974842140177RobooterBBR-E40-012026-07-24
06974842140504Robooter E60BBR-E60-042026-07-24
06974842140566RobooterBBR-E60-022026-07-24
06974842140580Robooter E60BBR-E60-042026-07-24
06974842140641Robooter E60BBR-E60-022026-07-24
06974842140665Robooter E60BBR-E60-042026-07-24
06974842140726Robooter E60BBR-E60-022026-07-24
06974842140740Robooter E60BBR-E60-042026-07-24
06974842142102RobooterBBR-E60GT-042026-07-24
06974842142119RobooterBBR-E60GT-052026-07-24
06974842142126RobooterBBR-E60GT-062026-07-24
06974842142140RobooterBBR-E60GT-082026-07-24
06974842142072Electric WheelchairBBR-E60GT-012026-07-23
06974842142089Electric WheelchairBBR-E60GT-022026-07-23
06974842142096Electric WheelchairBBR-E60GT-032026-07-23
06974842142133RobooterBBR-E60GT-072026-07-23
06974842141693Electric WheelchairBBR-LY-01-012026-07-07
06974842140474Electric Wheelchair(Robooter E60)BBR-E60-012024-07-29
06974842140559Electric Wheelchair(Robooter E60)BBR-E60-012024-07-29

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
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