Polar Care Wave
K-Number: K183702 · 2019-03-01
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Device Summary
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.
Related Clinical Trials
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
Other records listing Breg, Inc. as applicant
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
Related Devices (Code: IRP)
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
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.
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