Product code QNU

Device name: Transcutaneous Electrical Nerve Stimulator For The Relief Of Congestion
Medical specialty: Ear, Nose, Throat
Device class: 2
Regulation number: 874.6000
Review panel: EN
Implant: N
Life sustaining/supporting: N
GMP exempt: N
Third party review: N
Summary malfunction reporting: Ineligible
Definition: A transcutaneous electrical nerve stimulator for the relief of congestion is a device that electrically stimulates the skin overlying the paranasal sinuses to relieve congestion.
Source: FDA openFDA device classification dataset

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
DEN200006	ClearUP Sinus Relief	Tivic Health Systems, Inc.	2021-03-05

Primary DI, Brand, Company table
Primary DI	Brand	Company	Published
00850006251179	ClearUP Sinus Pain Relief	TIVIC HEALTH SYSTEMS INC.	2023-10-30
00850006251032	ClearUP Sinus Pain Relief	TIVIC HEALTH SYSTEMS INC.	2023-10-18
00850006251025	ClearUP Sinus Pain Relief	TIVIC HEALTH SYSTEMS INC.	2020-08-15
00850006251001	ClearUP Sinus Relief Pain	TIVIC HEALTH SYSTEMS INC.	2019-10-14

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