SmartDrive®

GUDID 00861896000303

MAX MOBILITY, LLC

Wheelchair electric-motor-driven propulsion system

• Primary Device ID: 00861896000303
• NIH Device Record Key: 636b10f9-b0bc-4ed4-a900-a121711ac57c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SmartDrive®
• Version Model Number: MX2
• Company DUNS: 189746204
• Company Name: MAX MOBILITY, 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: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00861896000303 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151199

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: 2016-09-23

On-Brand Devices [SmartDrive®]

• 00861896000310: MX2+
• 00861896000303: MX2