FDA.reportPublic FDA data

Paragolfer Power Wheelchair

Primary DI
04064406193656
Brand
Paragolfer Power Wheelchair
Company
Otto Bock Mobility Solutions GmbH
Model
490E54=00000_K
Published
2020-09-15
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
IPLWheelchair, Standup

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IPLWheelchair, StandupPhysical Medicine2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K060936000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K060936000PARAGOLFERParabasetec, GmbH2006-08-07IPL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04064406193656PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04064406193656040644061936564064406193656

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
341148586
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04032767034376Arm Support Offset Plate436H1=72024-04-09
04032767350711Kit for nut-modular armrest437A402024-04-09
04032767358595Heavy Duty Clamp complete, Black477L52=SK0552024-04-09
04064406089836Clinical Assembly Set (43-53cm), Black476D52=SK0152023-12-19
04064406089850Clinical Assembly Set (54-64cm), Black476D52=SK0252023-12-19
04064406089874Assembly Set (18-42 cm), Black476D52=SK0352023-12-19
04064406089898Assembly Set (40-54 cm), Black476D52=SK0452023-12-19
04064406089911Assembly Set (52-62 cm), Black476D52=SK0552023-12-19
04064406089935Clinical Assembly Set (38-42cm), Black476D52=SK0652023-12-19
04064406090221Head Support Mounting Hardware Multi-Crank, Black476L52=SK0152023-12-19
04064406090245Head Support Mounting Hardware Multi-Straigt, Black476L52=SK0252023-12-19
04064406065755"Clamp, 1"", Black"434H1=1-72023-12-19
04064406065779S.T.S. Clamp 3/4 Inch Black434H1=3/4-72023-12-19
04064406065793S.T.S. Clamp 7/8 Inch Black434H1=7/8-72023-12-19
04064406066592Channel Forearm Pad, Large436A2=1-72023-12-19
04064406066608Channel Forearm Pad, Medium436A2=2-72023-12-19
04064406066615Channel Forearm Pad, Small436A2=3-72023-12-19
04064406066622Channel Arm Support One Piece436A3=2-72023-12-19
04064406066752Hand Pad Palm Extenser436P2=L1-72023-12-19
04064406066769Hand Pad Palm Extenser436P2=L2-72023-12-19

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Primary DI, Brand, Company table
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09356399060974Magic XT2RED MILAWA PTY. LTD.IPL2024-11-18
17330818002003PermobilPERMOBIL, INC.IPL2023-08-15
17330818000993PermobilPERMOBIL, INC.IPL2023-07-07
07540147011444MODULAR POWER STANDING SYSTEMMotion Concepts IncIPL2021-08-12
07540147011451MODULAR POWER STANDING SYSTEMMotion Concepts IncIPL2021-08-12
00811478030013Tek RMDMatia Robotics (us), Inc.IPL2021-06-07
00811478030020Tek RMDMatia Robotics (us), Inc.IPL2021-06-07
00811478030037Tek RMDMatia Robotics (us), Inc.IPL2021-06-07
00811478030044Tek RMDMatia Robotics (us), Inc.IPL2021-06-07
00811478030051Tek RMDMatia Robotics (us), Inc.IPL2021-06-07
00811478030068Tek RMDMatia Robotics (us), Inc.IPL2021-06-07
00811478030075Tek RMDMatia Robotics (us), Inc.IPL2021-06-07
00016958059793Quickie Q700-UP M / Q700MSUNRISE MEDICAL (US) LLCIPL2021-05-03
00810058400031Karman HealthcareKARMAN HEALTHCARE INC.IPL2020-08-10
00810058400048Karman HealthcareKARMAN HEALTHCARE INC.IPL2020-08-10
00810058400055Karman HealthcareKARMAN HEALTHCARE INC.IPL2020-08-10
00859706005976Karman HealthcareKARMAN HEALTHCARE INC.IPL2020-08-10
00811478030006Tek Robotic Mobilization DeviceMatia Robotics (us), Inc.IPL2018-03-21
B289SS1F0SuperStand Standing WheelchairSTANDING COMPANY, THEIPL2017-01-30
00863444000308Redman/Chief Power ChairCHIEF POWER CHAIR, LLCIPL2016-12-19
08680905006905TEK Robotic Mobilization DeviceMATIA ROBOTICS MEKATRONIK SISTEMLER AR-GE MUHENDISLIK YAZILIM SANAYI VE TICARET A SIPL2016-09-25
B289HPS2SuperStand Standing WheelchairSTANDING COMPANY, THEIPL2016-09-24
B289PS2SuperStand Standing WheelchairSTANDING COMPANY, THEIPL2016-09-24
B289SS1SuperStand STANDING COMPANY, THEIPL2016-09-24
04032767048397ParaGolfer Power WheelchairOtto Bock Mobility Solutions GmbHIPL2016-09-15
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