Heat Pain Pro
K-Number: K160115 · 2016-06-03
ApplicantOmron Healthcare, Inc.
Decision Date2016-06-03
Product CodeNUH
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
Heat Pain Pro is a medical device manufactured by Omron Healthcare, Inc.. It received FDA 510(k) clearance on 2016-06-03 under approval number K160115. The device is classified under product code NUH. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Heat Pain Pro?
Heat Pain Pro is a medical device that received FDA 510(k) clearance on 2016-06-03. It is manufactured by Omron Healthcare, Inc.. The 510(k) number is K160115.
When was Heat Pain Pro approved by the FDA?
Heat Pain Pro received FDA 510(k) clearance on 2016-06-03, under approval number K160115.
What company makes Heat Pain Pro?
Heat Pain Pro is manufactured by Omron Healthcare, Inc..
What is the FDA product code for Heat Pain Pro?
The FDA product code for Heat Pain Pro is NUH.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.