Optimus

GUDID 06973175531010

Anhui JBH Medical Apparatus Co., Ltd.

Assistive scooter, electric-motor-driven

• Primary Device ID: 06973175531010
• NIH Device Record Key: 3dcf991e-1e88-45d5-8bcb-a04b4b8ef378
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Optimus
• Version Model Number: FDB01
• Company DUNS: 554547530
• Company Name: Anhui JBH Medical Apparatus Co., Ltd.
• 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	06973175531010 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K201196

FDA Product Code

• INI: Vehicle, Motorized 3-Wheeled

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: 2025-09-12
• Device Publish Date: 2025-09-04

Devices Manufactured by Anhui JBH Medical Apparatus Co., Ltd.

• 06973175530068 - JBH: 2025-09-12
• 06973175530952 - Phoenix: 2025-09-12
• 06973175530969 - Air Hawk: 2025-09-12
• 06973175530976 - Eagle HD: 2025-09-12
• 06973175531003 - Pegasus: 2025-09-12
• 06973175531010 - Optimus: 2025-09-12
• 06973175531010 - Optimus: 2025-09-12
• 06973175531027 - Pegasus Plus HD: 2025-09-12
• 06973175531041 - Matrix Ultra 2: 2025-09-12