Heat Pain Pro

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 Heat Pain Pro.

Pre-market Notification Details

• Device ID: K160115
• 510k Number: K160115
• Device Name: Heat Pain Pro
• Classification: Stimulator, Nerve, Transcutaneous, Over-the-counter
• Applicant: OMRON HEALTHCARE, INC. 1925 WEST FIELD COURT Lake Forest, IL 60045
• Contact: Renee Thornborough
• Correspondent: Paul Dryden; PROMEDIC, INC. 24301 WOODSAGE DR. Bonita Springs, FL 34134
• Product Code: NUH
• CFR Regulation Number: 882.5890 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2016-01-19
• Decision Date: 2016-06-03
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00073796637521	K160115	000
00073796633110	K160115	000