Aotedor

GUDID 06977027830504

Zhejiang Nysin Medical Co.,Ltd

Electric-motor-driven wheelchair, occupant-controlled

• Primary Device ID: 06977027830504
• NIH Device Record Key: b325008e-b7db-43fd-a1fc-785f68618265
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Aotedor
• Version Model Number: XFGW25-203
• Company DUNS: 632947785
• Company Name: Zhejiang Nysin Medical 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: true
• 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: true

Customer Support Contacts

• Phone: 19172152240
• Email: support@aotedor.com
• Phone: 19172152240
• Email: support@aotedor.com
• Phone: 19172152240
• Email: support@aotedor.com
• Phone: 19172152240
• Email: support@aotedor.com
• Phone: 19172152240
• Email: support@aotedor.com
• Phone: 19172152240
• Email: support@aotedor.com
• Phone: 19172152240
• Email: support@aotedor.com
• Phone: 19172152240
• Email: support@aotedor.com
• Phone: 19172152240
• Email: support@aotedor.com
• Phone: 19172152240
• Email: support@aotedor.com
• Phone: 19172152240
• Email: support@aotedor.com
• Phone: 19172152240
• Email: support@aotedor.com
• Phone: 19172152240
• Email: support@aotedor.com
• Phone: 19172152240
• Email: support@aotedor.com
• Phone: 19172152240
• Email: support@aotedor.com
• Phone: 19172152240
• Email: support@aotedor.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	06977027830504 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K212854

FDA Product Code

• ITI: Wheelchair, Powered

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: 2024-12-30
• Device Publish Date: 2024-12-21

Devices Manufactured by Zhejiang Nysin Medical Co.,Ltd

• 06977027830580 - ELECTRIC WHEELCHAIRS: 2025-04-30
• 06977027830542 - JustHero: 2025-04-04
• 06977027830504 - Aotedor: 2024-12-30
• 06977027830504 - Aotedor: 2024-12-30
• 06977027830498 - WOTURE: 2024-12-26
• 06977027830481 - ELECTRIC WHEELCHAIR: 2024-12-09
• 06977027830474 - VOCIC: 2024-11-27
• 06977027830467 - ELECTRIC WHEELCHAIR: 2024-11-26