Shenyu

GUDID 06950572844110

Ningbo Shenyu Medical Equipment Co.,Ltd

Wheelchair, attendant/occupant-driven, bimanual-chain-operated, collapsible

• Primary Device ID: 06950572844110
• NIH Device Record Key: 8026471e-9244-4dee-aeff-8a8be2de0d6d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Shenyu
• Version Model Number: SYIV100A011
• Company DUNS: 529654433
• Company Name: Ningbo Shenyu Medical Equipment 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: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06950572844110 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K201461

FDA Product Code

• IOR: Wheelchair, Mechanical

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: 2022-11-08
• Device Publish Date: 2022-10-31

On-Brand Devices [Shenyu]

• 06950572844110: SYIV100A011
• 06950572840099: D302
• 06950572840051: D022
• 06950572840044: D004
• 06950572840037: D003
• 06950572841300: R728BL-61(D023)