FDA.reportPublic FDA data

PS Scout

Primary DI
B314825651
Brand
PS Scout
Company
BURKE, INC.
Model
RF TPB
Catalog number
82565
Device description
Scout RF TPB
Published
2016-09-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

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
K982158000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K982158000SCOUTBurke, Inc.1998-08-31ITI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B314825651PrimaryHIBCC0

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

Contacts#

Phone, Email table
PhoneEmail
913-722-5658jernst@leisure-lift.com

Regulatory Flags#

DUNS number
045093101
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B313822501ScoutBoss 6NS822502016-09-01
B314150351PacesaverEspree Atlas150352016-09-01
B314150571PacesaverEspree Titan150572016-09-01
B314150631PacesaverPlus III Titan150632016-09-01
B314150671PacesaverPlus III Premier150672016-09-01
B314150681PacesaverEspree' Premier150682016-09-01
B314150701PacesaverPlus III Junior150702016-09-01
B314150721PacesaverEclipse Premier150722016-09-01
B314150731PacesaverEclipse Atlas150732016-09-01
B314150831PacesaverPlus III Atlas150832016-09-01
B314150851PacesaverFusion 450150852016-09-01
B314150861PaceSaverEspree Atlas 5150862016-09-01
B314150871PacesaverEclipse Atlas 5150872016-09-01
B314150901PacesaveFusion 500150902016-09-01
B314174771PacesaverFusion 350174772016-09-01
B314174781PaceSaverFusion 250174782016-09-01
B314634101Burke"Bari-Float Mattress 54"""634102016-09-01
B31481113A1ScoutRF - SP81113A2016-09-01
B314811221ScoutRF4811222016-09-01
B31481445A1ScoutM-1 81445A2016-09-01

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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04046727250935e-fix®Alber GmbHITI2026-05-26
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04046727251055e-fix®Alber GmbHITI2026-05-26
06973717276683Dahao MedicalFoshan Dahao Medical Technology Co., Ltd.ITI2026-05-26
06976245010361Power WheelchairZheJiang J&J Mobility Co., LtdITI2026-05-26
06976245010378Power WheelchairZheJiang J&J Mobility Co., LtdITI2026-05-26
00199874244891AMP plusMethod Mobility, Inc.ITI2026-05-25
00199874251073AMPMethod Mobility, Inc.ITI2026-05-25
00199874773407AMP jsMethod Mobility, Inc.ITI2026-05-25
06973717276690VerpalFoshan Dahao Medical Technology Co., Ltd.ITI2026-05-25
06976245010187Power WheelchairZheJiang J&J Mobility Co., LtdITI2026-05-25
06975028630116NINGBO YOUHUAN AUTOMATION TECHNOLOGY CO., LTD.Ningbo Youhuan Automation Technology Co., LtdITI2026-05-21
06975028630581NINGBO YOUHUAN AUTOMATION TECHNOLOGY CO., LTD.Ningbo Youhuan Automation Technology Co., LtdITI2026-05-21
06973175531300MOGOAnhui JBH Medical Apparatus Co., Ltd.ITI2026-05-09
06973175531317MOGOAnhui JBH Medical Apparatus Co., Ltd.ITI2026-05-09
06973175531324MOGOAnhui JBH Medical Apparatus Co., Ltd.ITI2026-05-09
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