Slow Wave, Inc.

FDA Device Registration & Listing · Spicewood, TX, US · Registration 3017520337

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3017520337
FEI Number
3017520337
Entity Name
Slow Wave, Inc.
City/State/Country
Spicewood, TX, US
Establishment Address
22111 Tx Hwy 71 W Ste 104, Spicewood, TX 78669, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Slow Wave, Inc. (Owner Number: 10078388)
Owner / Operator Contact Address
26100 Countryside Dr., Spicewood, TX 78669, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K240463
PMA Number
N/A

All Registered Proprietary Names

DS8 BROSA

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
OCO Mouthguard, Migraine/Tension Headache Unknown Class U N/A 2024-08-22
MQC Mouthguard, Prescription Unknown Class U N/A 2024-08-22

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Slow Wave, Inc.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Similar Registrations

Registration Number Establishment Name Location
3025434480 TMJ SERVICES LLC Franklin, TN, US
3030268763 OWL DENTAL San Leandro, CA, US
3009779268 PANTHERA DENTAL INC Quebec City, CA
3043044356 Remvia, LLC Saint Louis, MO, US
3017567754 3DPX MEDICAL Chicago, IL, US
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3017520337. Last updated year: 2026. Please use registration number 3017520337 when referencing this establishment in official correspondence.
Legal Disclaimer: AvaSpecs is not affiliated with the FDA or any government agency and does not provide medical, legal, regulatory, safety, approval, clearance, effectiveness, endorsement, or compliance advice. This index page is built using public record archives and does not represent an official regulatory determination.
Account Required Full available specs will require a free AvaSpecs account.