Vivally

GUDID 00860009634077

Avation Medical, Inc.

Transcutaneous incontinence-control electrical stimulator Transcutaneous incontinence-control electrical stimulator Transcutaneous incontinence-control electrical stimulator Transcutaneous incontinence-control electrical stimulator Transcutaneous incontinence-control electrical stimulator Transcutaneous incontinence-control electrical stimulator Transcutaneous incontinence-control electrical stimulator Transcutaneous incontinence-control electrical stimulator Transcutaneous incontinence-control electrical stimulator Transcutaneous incontinence-control electrical stimulator Transcutaneous incontinence-control electrical stimulator Transcutaneous incontinence-control electrical stimulator Transcutaneous incontinence-control electrical stimulator Transcutaneous incontinence-control electrical stimulator Transcutaneous incontinence-control electrical stimulator Transcutaneous incontinence-control electrical stimulator Transcutaneous incontinence-control electrical stimulator Transcutaneous incontinence-control electrical stimulator

• Primary Device ID: 00860009634077
• NIH Device Record Key: c6e5e56f-b456-450f-bff9-f006fad19e99
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vivally
• Version Model Number: VCG-GC301
• 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: false
• Lot Batch: true
• Serial Number: false
• 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: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860009634077 [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: 2023-08-09
• Device Publish Date: 2023-08-01

On-Brand Devices [Vivally]

• 00860009634015: VCG-KTM01
• 00860009634008: VCG-KTS01
• 00860009634084: VCG-GC501
• 00860009634077: VCG-GC301
• 00860009634046: VPG-KTS01