KD

GUDID 06970575220155

SUZHOU KD INTELLIGENT DEVICE CO., LTD

Electric-motor-driven wheelchair, occupant-controlled Electric-motor-driven wheelchair, occupant-controlled Electric-motor-driven wheelchair, occupant-controlled Electric-motor-driven wheelchair, occupant-controlled Electric-motor-driven wheelchair, occupant-controlled Electric-motor-driven wheelchair, occupant-controlled Electric-motor-driven wheelchair, occupant-controlled Electric-motor-driven wheelchair, occupant-controlled Electric-motor-driven wheelchair, occupant-controlled Electric-motor-driven wheelchair, occupant-controlled Electric-motor-driven wheelchair, occupant-controlled Electric-motor-driven wheelchair, occupant-controlled Electric-motor-driven wheelchair, occupant-controlled Electric-motor-driven wheelchair, occupant-controlled Electric-motor-driven wheelchair, occupant-controlled Electric-motor-driven wheelchair, occupant-controlled Electric-motor-driven wheelchair, occupant-controlled Electric-motor-driven wheelchair, occupant-controlled

• Primary Device ID: 06970575220155
• NIH Device Record Key: 5b97f692-e9fd-4042-8cde-44b4ca264436
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: KD
• Version Model Number: PL001-7003
• Company DUNS: 544250984
• Company Name: SUZHOU KD INTELLIGENT DEVICE 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: true
• 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	06970575220155 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K113463

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: 2024-05-22
• Device Publish Date: 2024-05-14

On-Brand Devices [KD]

• 06970575220179: PL001-3005
• 06970575220162: PL001-4001
• 06970575220155: PL001-7003
• 06970575220148: PL001-7002
• 06970575220124: PL001-3003
• 06970575220117: PL001-2004
• 06970575220100: PL001-2010
• 06970575220094: PL001-2003
• 06970575220087: PL001-8002