TUNG KENG

GUDID 04719884540019

TUNG KENG ENTERPRISE CO., LTD.

Electric-motor-driven wheelchair, occupant-controlled

• Primary Device ID: 04719884540019
• NIH Device Record Key: be49b78c-5de1-44ff-8325-15b339906152
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TUNG KENG
• Version Model Number: Zoomer
• Company DUNS: 656399912
• Company Name: TUNG KENG ENTERPRISE CO., LTD.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• 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	04719884540019 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K220156

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: 2024-01-26
• Device Publish Date: 2024-01-18

On-Brand Devices [TUNG KENG]

• 04719884540026: Joy Rider
• 04719884540019: Zoomer