BREEZ CHAIR

GUDID B7981025G0

MOTORIZED PATIENT TRANSPORT CHAIR

ELECTRO KINETIC TECHNOLOGIES, LLC

Wheelchair, electric-motor-driven, attendant-controlled, manual-steering, non-collapsible

• Primary Device ID: B7981025G0
• NIH Device Record Key: c50e41e8-a96c-48a5-8792-da5cb4a69c21
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BREEZ CHAIR
• Version Model Number: 1025-G
• Company DUNS: 832588763
• Company Name: ELECTRO KINETIC TECHNOLOGIES, LLC
• 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
HIBCC	B7981025G0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K111095

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: 2019-12-23
• Device Publish Date: 2019-12-13