Cleared Traditional

K162481 - RF1400 Active Compression Wrap

K162481 is an FDA 510(k) clearance for RF1400 Active Compression Wrap, manufactured by Recovery Force, LLC. The device is a Class 2 Cardiovascular device with product code JOW cleared through the Traditional 510(k) pathway after a 163-day FDA review.

K162481 · Recovery Force, LLC · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2017
Decision
163d
Days
Class 2
Risk

K162481 is an FDA 510(k) clearance for the RF1400 Active Compression Wrap. Classified as Sleeve, Limb, Compressible (product code JOW), Class II - Special Controls.

Submitted by Recovery Force, LLC (Fishers, US). The FDA issued a Cleared decision on February 16, 2017 after a review of 163 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.5800 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Recovery Force, LLC devices

FDA 510(k) Submission Details - K162481

510(k) Number K162481 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 06, 2016
Decision Date February 16, 2017
Days to Decision 163 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
38d slower than avg
Panel avg: 125d · This submission: 163d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JOW Device Classification - Class 2, Special Controls

Product Code JOW Sleeve, Limb, Compressible
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.5800
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 Cardiovascular devices follow this clearance model.

Regulatory Peers - JOW Sleeve, Limb, Compressible

All 124
Devices cleared under the same product code (JOW) and FDA review panel - the closest regulatory comparables to K162481.
Flowtron DVT5 Small Calf Garment
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Devon 24R Deep Vein Thrombosis (DVT) Prevention Therapy System
K173528 · Devon Medical Products (Jiangsu), Ltd. · Feb 2018
Medline Hemo-Force DVT Compression Sleeve
K170415 · Medline Industries, Inc. · Sep 2017
Reprocessed Kendall SCD Express Compression Sleeves, Reprocessed Kendall SCD Comfort Compression Sleeves
K163620 · Covidien · Jan 2017
Reprocessed Kendall SCD Express Foot Cuff
K163055 · Covidien · Dec 2016
Reprocessed Compression Garments
K161105 · Covidien · Aug 2016