Baichen

GUDID 06975185620104

NINGBO BAICHEN MEDICAL DEVICES CO., LTD

Electric-motor-driven wheelchair, occupant-controlled

• Primary Device ID: 06975185620104
• NIH Device Record Key: c1a53b61-ffe4-4665-b8d0-d1b967af3c32
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Baichen
• Version Model Number: Sonix BC-EA8000-530
• Company DUNS: 707021891
• Company Name: NINGBO BAICHEN MEDICAL DEVICES 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: false
• 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	06975185620104 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K250475

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: 2025-08-14
• Device Publish Date: 2025-08-06

On-Brand Devices [Baichen]

• 06975185620005: BC-EA8000
• 06975185620043: BC-EALD3
• 06975185620036: BC-EC8003
• 06975185620029: BC-EC8002
• 06975185620012: BC-EA5516
• 06975185620142: Sonix
• 06975185620135: Rubicon
• 06975185620128: Sonix BC-EA8000-9000
• 06975185620111: Sonix BC-EA5515
• 06975185620104: Sonix BC-EA8000-530
• 06975185620098: Rubicon BC-EALD3
• 06975185620081: Rubicon BC-EC8003
• 06975185620074: Rubicon BC-EA5516
• 06975185620067: Rubicon BC-EA8000
• 06975185620050: Rubicon BC-EC8002