TANGHOMY

GUDID 06977027830771

Zhejiang Nysin Medical Co.,Ltd

Electric-motor-driven wheelchair, occupant-controlled

• Primary Device ID: 06977027830771
• NIH Device Record Key: 971745f9-8d70-4b8d-b558-00b82941ea0a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TANGHOMY
• Version Model Number: XFGW30-107
• 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: 3038000162
• Email: USservice@dhaiyo.com
• Phone: 3038000162
• Email: USservice@dhaiyo.com
• Phone: 3038000162
• Email: USservice@dhaiyo.com
• Phone: 3038000162
• Email: USservice@dhaiyo.com
• Phone: 3038000162
• Email: USservice@dhaiyo.com
• Phone: 3038000162
• Email: USservice@dhaiyo.com
• Phone: 3038000162
• Email: USservice@dhaiyo.com
• Phone: 3038000162
• Email: USservice@dhaiyo.com
• Phone: 3038000162
• Email: USservice@dhaiyo.com
• Phone: 3038000162
• Email: USservice@dhaiyo.com
• Phone: 3038000162
• Email: USservice@dhaiyo.com
• Phone: 3038000162
• Email: USservice@dhaiyo.com
• Phone: 3038000162
• Email: USservice@dhaiyo.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	06977027830771 [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: 2025-08-11
• Device Publish Date: 2025-08-01

On-Brand Devices [TANGHOMY]

• 06977027830771: XFGW30-107
• 06977027830764: NXN20-208