Polar Care Wave— 510(k) K183702

Substantially Equivalent

Breg, Inc.

FDA 510(k) clearance K183702 for Polar Care Wave, Substantially Equivalent on 2019-03-01. Applicant: Breg, Inc..

Clearance details

Applicant: Breg, Inc.
Product code: Code IRP
Advisory panel: Physical Medicine
Date received: 2018-12-31
Decision date: 2019-03-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Carlsbad, CA, US

Download summary PDF View on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.