RoughRider

GUDID 00860009406032

manually propelled wheelchair

Roughrider America LLC

Push-rim manual wheelchair, non-bariatric

• Primary Device ID: 00860009406032
• NIH Device Record Key: 7df2ab1f-135d-4708-9167-3ba48ea9182d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RoughRider
• Version Model Number: RoughRider
• Company DUNS: 052942916
• Company Name: Roughrider America 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: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 5105481333
• Email: marc@roughrideramerica.com
• Phone: 5105481333
• Email: marc@roughrideramerica.com
• Phone: 5105481333
• Email: marc@roughrideramerica.com
• Phone: 5105481333
• Email: marc@roughrideramerica.com
• Phone: 5105481333
• Email: marc@roughrideramerica.com
• Phone: 5105481333
• Email: marc@roughrideramerica.com
• Phone: 5105481333
• Email: marc@roughrideramerica.com
• Phone: 5105481333
• Email: marc@roughrideramerica.com
• Phone: 5105481333
• Email: marc@roughrideramerica.com
• Phone: 5105481333
• Email: marc@roughrideramerica.com
• Phone: 5105481333
• Email: marc@roughrideramerica.com
• Phone: 5105481333
• Email: marc@roughrideramerica.com
• Phone: 5105481333
• Email: marc@roughrideramerica.com
• Phone: 5105481333
• Email: marc@roughrideramerica.com
• Phone: 5105481333
• Email: marc@roughrideramerica.com
• Phone: 5105481333
• Email: marc@roughrideramerica.com
• Phone: 5105481333
• Email: marc@roughrideramerica.com
• Phone: 5105481333
• Email: marc@roughrideramerica.com
• Phone: 5105481333
• Email: marc@roughrideramerica.com
• Phone: 5105481333
• Email: marc@roughrideramerica.com
• Phone: 5105481333
• Email: marc@roughrideramerica.com
• Phone: 5105481333
• Email: marc@roughrideramerica.com
• Phone: 5105481333
• Email: marc@roughrideramerica.com
• Phone: 5105481333
• Email: marc@roughrideramerica.com
• Phone: 5105481333
• Email: marc@roughrideramerica.com
• Phone: 5105481333
• Email: marc@roughrideramerica.com
• Phone: 5105481333
• Email: marc@roughrideramerica.com
• Phone: 5105481333
• Email: marc@roughrideramerica.com
• Phone: 5105481333
• Email: marc@roughrideramerica.com
• Phone: 5105481333
• Email: marc@roughrideramerica.com
• Phone: 5105481333
• Email: marc@roughrideramerica.com
• Phone: 5105481333
• Email: marc@roughrideramerica.com
• Phone: 5105481333
• Email: marc@roughrideramerica.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860009406032 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K103212

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: 2023-02-27
• Device Publish Date: 2023-02-17

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