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 ID: K172079
• 510k Number: K172079
• Device Name: Avail
• Classification: Stimulator, Nerve, Transcutaneous, Over-the-counter
• Applicant: Omron Healthcare, Inc. 1925 West Field Court Lake Forest, IL 60045
• Contact: Renee Thornborough
• Correspondent: Ronald S. Warren; Experien Group 224 Airport Parkway, Suite 250 San Jose, CA 95110
• Product Code: NUH
• CFR Regulation Number: 882.5890 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2017-07-10
• Decision Date: 2017-10-19
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
10073796636019	K172079	000
20073796346144	K172079	000
20073796276144	K172079	000