FDA.reportPublic FDA data

Scooter, Electric

Primary DI
B247GC540
Brand
Scooter, Electric
Company
GOLDEN BROTHERS, INC.
Model
GC540
Catalog number
GC540
Device description
Electric Scooter
Published
2025-12-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
K012258000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K012258000COMPANION MODEL 221, 321, 421Golden Technologies, Inc.2001-12-03INI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B247GC540PrimaryHIBCC0

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. Commonly referred to as a mobility scooter, it 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
150742401
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B247GC240Scooter, ElectricGC240GC2402025-12-08
B247GC340Scooter, ElectricGC340GC3402025-12-08
B247GC440Scooter, ElectricGC440GC4402025-12-08
B247GC640Scooter, ElectricGC640GC6402025-12-08
B247GP306Wheelchair PoweredGP306GP3062025-12-08
B247GP307Wheelchair PoweredGP307GP3072025-12-08
B247PL102Chair, Electric PosiitioningPL1022025-12-08
B247PL103Chair, Electric PosiitioningPL1032025-12-08
B247PR104Chair, Electric PosiitioningPR1042025-12-08
B247PR401Chair, Electric PosiitioningPR4012025-12-08
B247PR446Chair, Electric PosiitioningPR4462025-12-08
B247PR454Chair, Electric PosiitioningPR4542025-12-08
B247PR455Chair, Electric PosiitioningPR4552025-12-08
B247UC105Chair, Electric PosiitioningUC1052025-12-08
B247UC464Chair, Electric PosiitioningUC4642025-12-08
B247UC465Chair, Electric PosiitioningUC4652025-12-08
B247UC476Chair, Electric PosiitioningUC4762025-12-08
B247UC480Chair, Electric PosiitioningUC4802025-12-08
B247GR596Scooter, ElectricGR5962025-08-19
B247PR519Chair, Electric PositioningPR5192025-08-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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
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06975185620173BaichenNINGBO BAICHEN MEDICAL DEVICES CO., LTDINI2026-01-07
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