Slow Wave SWDS801

GUDID 00860007686603

Slow Wave, Inc.

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

• Primary Device ID: 00860007686603
• NIH Device Record Key: 60bd6d82-a278-4b5f-a158-0b951a259fcc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Slow Wave
• Version Model Number: DS8
• Catalog Number: SWDS801
• 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	00860007686603 [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