Cleared Traditional

K182668 - Rapid Reboot Compression Therapy System

K182668 is the FDA 510(k) clearance for Rapid Reboot Compression Therapy System by Rapid Reboot Recovery Products, LLC. It is a Class 2 Physical Medicine device (product code IRP) cleared through the Traditional 510(k) pathway after a 80-day FDA review.

K182668 · Rapid Reboot Recovery Products, LLC · Physical Medicine device
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Dec 2018
Decision
80d
Days
Class 2
Risk

K182668 is an FDA 510(k) clearance for the Rapid Reboot Compression Therapy System. Classified as Massager, Powered Inflatable Tube (product code IRP), Class II - Special Controls.

Submitted by Rapid Reboot Recovery Products, LLC (Lindon, US). The FDA issued a Cleared decision on December 14, 2018 after a review of 80 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 Rapid Reboot Recovery Products, LLC devices

Submission Details

510(k) Number K182668 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 25, 2018
Decision Date December 14, 2018
Days to Decision 80 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
35d faster than avg
Panel avg: 115d · This submission: 80d
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 Consultant

FDA Consulting, LLC
John F Gillespy

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - IRP Massager, Powered Inflatable Tube

All 96
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