Bounder

GUDID 00861980000400

21ST CENTURY SCIENTIFIC, INC.

Wheelchair, power-assisted, occupant-controlled, non-collapsible

• Primary Device ID: 00861980000400
• NIH Device Record Key: 831eab54-9367-449f-bc90-bf6a1b1e88f0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bounder
• Version Model Number: BOUNDER PLUS
• Company DUNS: 099447922
• Company Name: 21ST CENTURY SCIENTIFIC, INC.
• 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: true
• 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	00861980000400 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K901210

FDA Product Code

• ITI: Wheelchair, Powered

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-07-05

On-Brand Devices [Bounder]

• 00861980000424: BOUNDER 300M
• 00861980000417: BIG BOUNDER
• 00861980000400: BOUNDER PLUS
• 00861980000479: BIG BOUNDER 1000
• 00861980000462: BIG BOUNDER 600
• 00861980000455: BOUNDER 450
• 00861980000448: BOUNDER PLUS 300
• 00861980000431: BOUNDER 300