Zhonglei

GUDID 06977100780030

Zhejiang Zhonglei Medical Technology Co.Ltd

Electric-motor-driven wheelchair, occupant-controlled

• Primary Device ID: 06977100780030
• NIH Device Record Key: f25e0fc1-f69f-4375-8dc8-739d2e328a8a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Zhonglei
• Version Model Number: Power wheelchair (N6103)
• Company DUNS: 639611338
• Company Name: Zhejiang Zhonglei Medical Technology 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	06977100780030 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K242402

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: 2025-05-07
• Device Publish Date: 2025-04-29

On-Brand Devices [Zhonglei]

• 06977100780009: Power wheelchair(N6101)
• 06977100780030: Power wheelchair (N6103)
• 06977100780023: Power wheelchair (N6102)