Vivally

GUDID 00850053656033

Avation Medical, Inc.

Transcutaneous incontinence-control electrical stimulator

• Primary Device ID: 00850053656033
• NIH Device Record Key: db61fa2b-1272-44cb-87a3-f6304106713f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vivally
• Version Model Number: VCG-KDM01
• Company DUNS: 081061890
• Company Name: Avation Medical, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: false
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850053656033 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K220454

FDA Product Code

• NAM: Stimulator, Peripheral Nerve, Non-Implanted, For Urinary Incontinence

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: 2024-11-06
• Device Publish Date: 2024-10-29

On-Brand Devices [Vivally]

• 00860009634015: VCG-KTM01
• 00860009634008: VCG-KTS01
• 00860009634084: VCG-GC501
• 00860009634077: VCG-GC301
• 00860009634046: VPG-KTS01
• 00860009634053: VCG-SRN01
• 00860009634039: VCG-GAS01
• 00860009634022: VCG-GAM01
• 00850053656033: VCG-KDM01
• 00850053656026: VCG-KDS01