ParaGolfer

GUDID 04032767817948

Otto Bock Mobility Solutions GmbH

Wheelchair, electric-motor-driven, occupant-controlled, powered-steering, non-collapsible

• Primary Device ID: 04032767817948
• NIH Device Record Key: 7df2c0ce-5b16-4863-b8f0-6afd72ba138b
• Commercial Distribution Discontinuation: 2020-03-18
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: ParaGolfer
• Version Model Number: 490E54=00000
• Company DUNS: 341148586
• Company Name: Otto Bock Mobility Solutions GmbH
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04032767817948 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K060936

FDA Product Code

• IPL: Wheelchair, Standup

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-09-16
• Device Publish Date: 2016-09-15

Devices Manufactured by Otto Bock Mobility Solutions GmbH

• 04032767034376 - Arm Support Offset Plate: 2024-04-17
• 04032767350711 - Kit for nut-modular armrest: 2024-04-17
• 04032767358595 - Heavy Duty Clamp complete, Black: 2024-04-17
• 04064406065755 - Clamp, 1", Black: 2023-12-27
• 04064406065779 - S.T.S. Clamp 3/4 Inch Black: 2023-12-27
• 04064406065793 - S.T.S. Clamp 7/8 Inch Black: 2023-12-27
• 04064406066592 - Channel Forearm Pad, Large: 2023-12-27
• 04064406066608 - Channel Forearm Pad, Medium: 2023-12-27