Slow Wave SWAT01

GUDID 00860007686610

Slow Wave, Inc.

Mandible-repositioning/palate-lifting sleep-disordered breathing orthosis

• Primary Device ID: 00860007686610
• NIH Device Record Key: c3bdb0d4-dc16-41bb-8f32-72cb36c746cd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Slow Wave
• Version Model Number: AT
• Catalog Number: SWAT01
• Company DUNS: 035177408
• Company Name: Slow Wave, Inc.
• 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: false
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860007686610 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191320

FDA Product Code

• LQZ: Device, Jaw Repositioning

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: 2023-05-11
• Device Publish Date: 2023-05-03

On-Brand Devices [Slow Wave]

• 00860007686610: AT
• 00860007686603: DS8
• 00860007686627: BROSA