Cleared Traditional

K183702 - Polar Care Wave

K183702 is the FDA 510(k) clearance for Polar Care Wave by Breg, Inc.. It is a Class 2 Physical Medicine device (product code IRP) cleared through the Traditional 510(k) pathway after a 60-day FDA review.

K183702 · Breg, Inc. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2019
Decision
60d
Days
Class 2
Risk

K183702 is an FDA 510(k) clearance for the Polar Care Wave. Classified as Massager, Powered Inflatable Tube (product code IRP), Class II - Special Controls.

Submitted by Breg, Inc. (Carlsbad, US). The FDA issued a Cleared decision on March 1, 2019 after a review of 60 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5650 - the FDA physical medicine device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Breg, Inc. devices

Submission Details

510(k) Number K183702 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 31, 2018
Decision Date March 01, 2019
Days to Decision 60 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
55d faster than avg
Panel avg: 115d · This submission: 60d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code IRP Massager, Powered Inflatable Tube
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5650
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Physical Medicine devices follow this clearance model.

Regulatory Peers - IRP Massager, Powered Inflatable Tube

All 96
Devices cleared under the same product code (IRP) and FDA review panel - the closest regulatory comparables to K183702.
Recovery Pump, 737R (RPX)
K190493 · Mego Afek AC , Ltd. · May 2019
Therm-X
K190854 · Zenith Technical Innovations · May 2019
Ballancer Gold, 1212
K190015 · Mego Afek AC , Ltd. · Mar 2019
Pressure Therapy System PT1003
K181409 · Xiamen Senyang Co., Ltd. · Feb 2019
Pulse 2.0, Pulse Pro 2.0
K183169 · NormaTec Industries, LP · Dec 2018
Rapid Reboot Compression Therapy System
K182668 · Rapid Reboot Recovery Products, LLC · Dec 2018