Avail

Stimulator, Nerve, Transcutaneous, Over-the-counter

Omron Healthcare, Inc.

The following data is part of a premarket notification filed by Omron Healthcare, Inc. with the FDA for Avail.

Pre-market Notification Details

Device IDK172079
510k NumberK172079
Device Name:Avail
ClassificationStimulator, Nerve, Transcutaneous, Over-the-counter
Applicant Omron Healthcare, Inc. 1925 West Field Court Lake Forest,  IL  60045
ContactRenee Thornborough
CorrespondentRonald S. Warren
Experien Group 224 Airport Parkway, Suite 250 San Jose,  CA  95110
Product CodeNUH  
CFR Regulation Number882.5890 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-07-10
Decision Date2017-10-19
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10073796636019 K172079 000
20073796346144 K172079 000
20073796276144 K172079 000

Trademark Results [Avail]

Mark Image

Registration | Serial
Company
Trademark
Application Date
AVAIL
AVAIL
98380413 not registered Live/Pending
NHY International Inc
2024-01-29
AVAIL
AVAIL
98361090 not registered Live/Pending
Zest Comics, Inc.
2024-01-17
AVAIL
AVAIL
98046055 not registered Live/Pending
Avnet, Inc.
2023-06-16
AVAIL
AVAIL
98036415 not registered Live/Pending
Avail Gear LLC
2023-06-09
AVAIL
AVAIL
98036408 not registered Live/Pending
Avail Gear LLC
2023-06-09
AVAIL
AVAIL
97976969 not registered Live/Pending
Avail, LLC
2022-11-07
AVAIL
AVAIL
97666833 not registered Live/Pending
Avail, LLC
2022-11-07
AVAIL
AVAIL
97554862 not registered Live/Pending
AIS Holding Company LLC
2022-08-18
AVAIL
AVAIL
97554856 not registered Live/Pending
AIS Holding Company LLC
2022-08-18
AVAIL
AVAIL
97336147 not registered Live/Pending
Miracle-Ear, Inc.
2022-03-29
AVAIL
AVAIL
97234839 not registered Live/Pending
Automatic Equipment Manufacturing Co.
2022-01-24
AVAIL
AVAIL
90750539 not registered Live/Pending
Smith & Wesson Inc.
2021-06-02

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