TiLite

GUDID 00853316008129

Tilite

Push-rim manual wheelchair, non-bariatric

• Primary Device ID: 00853316008129
• NIH Device Record Key: c8aef574-f69d-41d7-9dbb-2c1c076ddd8f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TiLite
• Version Model Number: TiLite X
• Company DUNS: 059012893
• Company Name: Tilite
• 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	00853316008129 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K072311

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: 2024-07-24
• Device Publish Date: 2024-07-16

On-Brand Devices [TiLite]

• 00853316008105: TX
• 00853316008099: Twist
• 00853316008082: Pilot
• 00853316008075: 2GX
• 00853316008068: Aero X
• 00853316008051: ZRA
• 00853316008044: ZR
• 00853316008037: TRA
• 00853316008020: TR
• 00853316008013: Aero T
• 00853316008006: Aero Z
• 00853316008112: CR1
• 00853316008136: TiLite Z
• 00853316008129: TiLite X