ParaGolfer

GUDID 04032767817948

Otto Bock Mobility Solutions GmbH

Wheelchair, electric-motor-driven, occupant-controlled, powered-steering, non-collapsible Wheelchair, electric-motor-driven, occupant-controlled, powered-steering, non-collapsible Wheelchair, electric-motor-driven, occupant-controlled, powered-steering, non-collapsible Wheelchair, electric-motor-driven, occupant-controlled, powered-steering, non-collapsible Wheelchair, electric-motor-driven, occupant-controlled, powered-steering, non-collapsible Wheelchair, electric-motor-driven, occupant-controlled, powered-steering, non-collapsible Wheelchair, electric-motor-driven, occupant-controlled, powered-steering, non-collapsible Wheelchair, electric-motor-driven, occupant-controlled, powered-steering, non-collapsible Wheelchair, electric-motor-driven, occupant-controlled, powered-steering, non-collapsible Wheelchair, electric-motor-driven, occupant-controlled, powered-steering, non-collapsible Wheelchair, electric-motor-driven, occupant-controlled, powered-steering, non-collapsible Wheelchair, electric-motor-driven, occupant-controlled, powered-steering, non-collapsible Wheelchair, electric-motor-driven, occupant-controlled, powered-steering, non-collapsible Wheelchair, electric-motor-driven, occupant-controlled, powered-steering, non-collapsible
Primary Device ID04032767817948
NIH Device Record Key7df2c0ce-5b16-4863-b8f0-6afd72ba138b
Commercial Distribution Discontinuation2020-03-18
Commercial Distribution StatusNot in Commercial Distribution
Brand NameParaGolfer
Version Model Number490E54=00000
Company DUNS341148586
Company NameOtto Bock Mobility Solutions GmbH
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS104032767817948 [Primary]
GS104032767817948 [Primary]
GS104032767817948 [Primary]
GS104032767817948 [Primary]
GS104032767817948 [Primary]
GS104032767817948 [Primary]
GS104032767817948 [Primary]
GS104032767817948 [Primary]
GS104032767817948 [Primary]
GS104032767817948 [Primary]
GS104032767817948 [Primary]
GS104032767817948 [Primary]
GS104032767817948 [Primary]
GS104032767817948 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

IPLWheelchair, Standup
IPLWheelchair, Standup
IPLWheelchair, Standup
IPLWheelchair, Standup
IPLWheelchair, Standup
IPLWheelchair, Standup
IPLWheelchair, Standup
IPLWheelchair, Standup
IPLWheelchair, Standup
IPLWheelchair, Standup
IPLWheelchair, Standup
IPLWheelchair, Standup
IPLWheelchair, Standup
IPLWheelchair, Standup

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-09-16
Device Publish Date2016-09-15

Devices Manufactured by Otto Bock Mobility Solutions GmbH

04032767048243 - Skippi2020-09-16
04032767048397 - ParaGolfer Power Wheelchair2020-09-16
04032767048700 - Skippi Power Wheelchair for Children2020-09-16
04032767402526 - ParaGolfer Power wheelchair2020-09-16
04032767402533 - Skippi Power Wheelchair for Children2020-09-16
04032767817948 - ParaGolfer2020-09-16
04032767817948 - ParaGolfer2020-09-16

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