Bowhead Era

GUDID 00860013500900

Light Weight Wheelchair

Bowhead Design Corporation

Push-rim manual wheelchair, non-bariatric

• Primary Device ID: 00860013500900
• NIH Device Record Key: bf1dfb94-01b7-4ca6-8a4b-3ff15d9e0d54
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bowhead Era
• Version Model Number: A
• Company DUNS: 204685683
• Company Name: Bowhead Design Corporation
• 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: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860013500900 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K243111

FDA Product Code

• IOR: Wheelchair, Mechanical

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: 2025-03-24
• Device Publish Date: 2025-03-15