FDA.reportPublic FDA data

ParaGolfer Power Wheelchair

Primary DI
04032767048397
Brand
ParaGolfer Power Wheelchair
Company
Otto Bock Mobility Solutions GmbH
Model
490E54=00000_K
Published
2016-09-15
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
04032767048397PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04032767048397040327670483974032767048397

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
341148586
Device count
1
Serial number
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
04064406193656Paragolfer Power Wheelchair490E54=00000_K2020-09-15
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

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Primary DI, Brand, Company table
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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
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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
04064406193656Paragolfer Power WheelchairOtto Bock Mobility Solutions GmbHIPL2020-09-15
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
04032767402526ParaGolfer Power wheelchairOtto Bock Mobility Solutions GmbHIPL2016-09-15