FDA.reportPublic FDA data

WHEELCHAIR POWERED

Primary DI
B247GP161
Brand
WHEELCHAIR POWERED
Company
GOLDEN BROTHERS, INC.
Model
GP161
Catalog number
GP161
Device description
BATTERY POWERED WHEELCHAIR
Published
2021-09-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
K011153000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K011153000ALANTE, BATTERY OPERATED POWER WHEELCHAIRGolden Technologies, Inc.2001-05-29ITI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B247GP161PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Wheelchair, electric-motor-driven, 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 are performed by the occupant of the device. The device cannot be folded or readily dismantled for transport.

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
B247GC540Scooter, ElectricGC540GC5402025-12-08
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00841447198116INVACARE® PRONTO® M61™ POWER WHEELCHAIRINVACARE CORPORATIONITI2026-09-20
00841447198123INVACARE® PRONTO® M61™ POWER WHEELCHAIRINVACARE CORPORATIONITI2026-09-20
00841447198130INVACARE® PRONTO® M61™ POWER WHEELCHAIRINVACARE CORPORATIONITI2026-09-20
00841447198147INVACARE® PRONTO® M61™ POWER WHEELCHAIRINVACARE CORPORATIONITI2026-09-20
00841447198154INVACARE® PRONTO® M61™ POWER WHEELCHAIRINVACARE CORPORATIONITI2026-09-20
00841447198161INVACARE® PRONTO® M61™ POWER WHEELCHAIRINVACARE CORPORATIONITI2026-09-20
00841447198178INVACARE® PRONTO® M61™ POWER WHEELCHAIRINVACARE CORPORATIONITI2026-09-20
00841447198185INVACARE® PRONTO® M61™ POWER WHEELCHAIRINVACARE CORPORATIONITI2026-09-20
00841447198192INVACARE® PRONTO® M61™ POWER WHEELCHAIRINVACARE CORPORATIONITI2026-09-20
00841447198208INVACARE® PRONTO® M61™ POWER WHEELCHAIRINVACARE CORPORATIONITI2026-09-20
00841447198215INVACARE® PRONTO® 31 POWER WHEELCHAIRINVACARE CORPORATIONITI2026-09-20
00841447198222INVACARE® PRONTO® 31 POWER WHEELCHAIRINVACARE CORPORATIONITI2026-09-20
00841447198239INVACARE® PRONTO® AIR PERSONAL TRANSPORTER W/ MYBODY® SEATINGINVACARE CORPORATIONITI2026-09-20
00841447198246INVACARE® PRONTO® AIR PERSONAL TRANSPORTER W/ MYBODY® SEATINGINVACARE CORPORATIONITI2026-09-20
00841447198253INVACARE® PRONTO® M91™ POWER WHEELCHAIRINVACARE CORPORATIONITI2026-09-20
00841447198260INVACARE® PRONTO® M91™ POWER WHEELCHAIRINVACARE CORPORATIONITI2026-09-20
00841447198277INVACARE® TDX® SP POWER WHEELCHAIRINVACARE CORPORATIONITI2026-09-20
00841447198284INVACARE® TDX® SP POWER WHEELCHAIRINVACARE CORPORATIONITI2026-09-20
00841447198291INVACARE® 3G STORM SERIES® TORQUE™ 3 POWER WHEELCHAIRINVACARE CORPORATIONITI2026-09-20
00841447198307INVACARE® PRONTO® M41™ POWER WHEELCHAIRINVACARE CORPORATIONITI2026-09-20
00841447198314INVACARE® PRONTO® M51™ POWER WHEELCHAIRINVACARE CORPORATIONITI2026-09-20
00841447198321INVACARE® PRONTO® M41™ POWER WHEELCHAIRINVACARE CORPORATIONITI2026-09-20
00841447198338INVACARE® PRONTO® M51™ POWER WHEELCHAIRINVACARE CORPORATIONITI2026-09-20
00841447198345INVACARE® 3G STORM SERIES® TORQUE™ 3 POWER WHEELCHAIRINVACARE CORPORATIONITI2026-09-20
00841447198352INVACARE® PRONTO® M91™ POWER WHEELCHAIRINVACARE CORPORATIONITI2026-09-20
00841447198369INVACARE® 3G STORM SERIES® ARROW® POWER WHEELCHAIRINVACARE CORPORATIONITI2026-09-20
00841447198376INVACARE® TDX® SP POWER WHEELCHAIRINVACARE CORPORATIONITI2026-09-20
00841447198383INVACARE® 3G STORM SERIES® TORQUE™ SP POWER WHEELCHAIRINVACARE CORPORATIONITI2026-09-20
00841447198390INVACARE® TDX® SR POWER WHEELCHAIRINVACARE CORPORATIONITI2026-09-20
00841447198406INVACARE® 3G STORM SERIES® TORQUE™ 3 POWER WHEELCHAIRINVACARE CORPORATIONITI2026-09-20