Robooter

GUDID 06974842140153

Main structural composition of products: Motor, storage battery, control system, wheel, seat, handrail and pedal.

Shanghai Bangbang Robotics Co.,Ltd.

Electric-motor-driven wheelchair, occupant-controlled

• Primary Device ID: 06974842140153
• NIH Device Record Key: c2947421-6b44-4868-8bea-31c7cd1b0357
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Robooter
• Version Model Number: BBR-E40-01
• Company DUNS: 544486463
• Company Name: Shanghai Bangbang Robotics Co.,Ltd.
• 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: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	06974842140153 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K231868

FDA Product Code

• ITI: Wheelchair, Powered

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-04-19
• Device Publish Date: 2024-04-11

On-Brand Devices [Robooter]

• 06974842140016: Main structural composition of products:Motor,storage battery,control system,wheel,seat,handrail
• 06974842140153: Main structural composition of products: Motor, storage battery, control system, wheel, seat, ha