Slow Wave

GUDID 00860007686627

Slow Wave, Inc.

Custom-made mouthguard
Primary Device ID00860007686627
NIH Device Record Key85250637-956f-4bdc-941c-df0b16991bf6
Commercial Distribution StatusIn Commercial Distribution
Brand NameSlow Wave
Version Model NumberBROSA
Company DUNS035177408
Company NameSlow Wave, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100860007686627 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MQCMouthguard, Prescription

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-10-02
Device Publish Date2025-09-24

On-Brand Devices [Slow Wave]

00860007686610AT
00860007686603DS8
00860007686627BROSA

Trademark Results [Slow Wave]

Mark Image

Registration | Serial
Company
Trademark
Application Date
SLOW WAVE
SLOW WAVE
97975622 not registered Live/Pending
Slow Wave, Inc.
2021-11-30
SLOW WAVE
SLOW WAVE
97148354 not registered Live/Pending
Slow Wave, Inc.
2021-11-30
SLOW WAVE
SLOW WAVE
90724281 not registered Live/Pending
CoFactor, Inc.
2021-05-20
SLOW WAVE
SLOW WAVE
87935141 5711553 Live/Registered
Young, Robert
2018-05-24

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