Decision Date2019-03-01
Product CodeIRP
Advisory CommitteePM
DecisionSubstantially Equivalent
Device Summary
Polar Care Wave is the device name listed in this FDA 510(k) record. The listed applicant is Breg, Inc.. It received FDA 510(k) clearance on 2019-03-01 under 510(k) number K183702. The device is classified under product code IRP. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Polar Care Wave?
Polar Care Wave is a medical device that received FDA 510(k) clearance on 2019-03-01. The listed applicant is Breg, Inc.. The 510(k) number is K183702.
When did Polar Care Wave receive FDA 510(k) clearance?
Polar Care Wave received FDA 510(k) clearance on 2019-03-01, under 510(k) number K183702.
Who is the listed applicant for Polar Care Wave?
The FDA 510(k) record lists Breg, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Polar Care Wave?
The FDA product code for Polar Care Wave is IRP.
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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.