ClearUP Sinus Pain Relief

Stimulator, Nerve, Transcutaneous, For Pain Relief

Tivic Health Systems Inc.

The following data is part of a premarket notification filed by Tivic Health Systems Inc. with the FDA for Clearup Sinus Pain Relief.

Pre-market Notification Details

• Device ID: K182025
• 510k Number: K182025
• Device Name: ClearUP Sinus Pain Relief
• Classification: Stimulator, Nerve, Transcutaneous, For Pain Relief
• Applicant: Tivic Health Systems Inc. 750 Menlo Ave #200 Menlo Park, CA 94025
• Contact: Nina Peled
• Correspondent: Nina Peled; Medical Device Regulatory Consultant 550 Davis St, Unit 27 San Francisco, CA 94111
• Product Code: GZJ
• CFR Regulation Number: 882.5890 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2018-07-30
• Decision Date: 2019-01-02
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00850006251001	K182025	000
00850006251025	K182025	000