FLOWELL

GUDID 36971234470219

Xiamen Weiyou Intelligent Technology Co.,Ltd

Freestanding electric massager

• Primary Device ID: 36971234470219
• NIH Device Record Key: 6300e0f0-9c69-4d08-be49-d7534e055f7b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FLOWELL
• Version Model Number: FW-IPC4M
• Company DUNS: 549592185
• Company Name: Xiamen Weiyou Intelligent 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: 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	36971234470219 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K233238

FDA Product Code

• IRP: Massager, Powered Inflatable Tube

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: 2024-11-12
• Device Publish Date: 2024-11-04

On-Brand Devices [FLOWELL]

• 36971234470240: FW-IPC06T
• 36971234470226: FW-IPC06T
• 36971234470219: FW-IPC4M
• 36971234470202: FW-IPC4M
• 06971234470249: FW-IPC06T
• 06971234470225: FW-IPC06T
• 06971234470218: FW-IPC4M
• 06971234470201: FW-IPC4M