Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Polar Care Wave

K-Number: K183702 · 2019-03-01

ApplicantBreg, Inc.
Decision Date2019-03-01
Product CodeIRP
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

Polar Care Wave is a medical device manufactured by Breg, Inc.. It received FDA 510(k) clearance on 2019-03-01 under approval 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. It is manufactured by Breg, Inc.. The 510(k) number is K183702.

When was Polar Care Wave approved by the FDA?

Polar Care Wave received FDA 510(k) clearance on 2019-03-01, under approval number K183702.

What company makes Polar Care Wave?

Polar Care Wave is manufactured by Breg, Inc..

What is the FDA product code for Polar Care Wave?

The FDA product code for Polar Care Wave is IRP.

Related Devices (Code: IRP)

K160608NormaTec Pulse and NormaTec Pulse ProNormaTec Industries, LP K171685Med4 EliteCool Systems, Inc. (Dba Game Ready) K161907Pressure Therapy SystemXiamen Senyang Co., Ltd. K163280RP Lite 760RMego Afek AC , Ltd. K160178Lympha-Flow(LF1200)Daesung Maref Co., Ltd. K183169Pulse 2.0, Pulse Pro 2.0NormaTec Industries, LP

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.

↑