Manufacturer registered with FDA

Slow Wave, Inc.

Spicewood, TX, United States. Lists 2 dental device types with FDA across 1 registered establishment, and holds 1 510(k) clearance as applicant.

FDA owner/operator10078388Manufacturer

Device types listed: 2
Brands and models: 2
510(k) clearances: 12020–2020
Markets registered in: 1United States
Establishments: 1United States

510(k) clearances per year, 2007–2026

Devices listed with FDA

What Slow Wave, Inc. currently lists, by FDA device type, with the brand and model names on the listing.

Device type	Category	Role	Brands and models	Listed since
Jaw Repositioning DeviceLQZ · Class 2	Anti-snoring & jaw-repositioning devices	Maker	Slow Wave DS8	2020
Anti-Snoring DeviceLRK · Class 2	Anti-snoring & jaw-repositioning devices	Maker	Slow Wave DS8	2020

Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026

510(k) clearances

Clearances on which FDA names Slow Wave, Inc. as the applicant.

Decided	510(k)	Device	Device type
2 Oct 2020	K191320	Slow Wave DS8	LQZ Jaw Repositioning Device

Registered establishments

Establishment	Location	What it does
Slow Wave, Inc.FDA reg. 3017520337	Lakeway, TX, United States	Manufacturer

Sources

FDA establishment registration & device listing (search FDA, owner/operator 10078388). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.