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Rapid Reboot Compression Therapy System

FDA 510(k)

Class II (US FDA 510(k))

510(k) K182668

by Rapid Reboot Recovery Products, LLC

Identifiers

510(k) Number
K182668 FDA 510(k)
FDA Product Code
IRP FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 890.5650 FDA 510(k)
Regulation Number
890.5650 FDA 510(k)
Advisory Committee
Physical Medicine FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Rapid Reboot Compression Therapy System is a powered inflatable tube massager. It is designed to provide pneumatic compression therapy.

This device is regulated under FDA 510K clearance as a Class 2 medical device. It is categorized under physical medicine and is identified by product code IRP.

Frequently asked questions

What is the primary function of the Rapid Reboot Compression Therapy System?

This device is a powered inflatable tube massager designed to provide pneumatic compression therapy for physical medicine applications.

How is this device classified for regulatory purposes?

The Rapid Reboot Compression Therapy System is regulated as a Class 2 medical device under FDA 510K clearance, identified by product code IRP and regulation number 890.5650.

What is the regulatory status of this device?

The device has received FDA 510K clearance, which indicates that it has been determined to be substantially equivalent to other legally marketed predicate devices.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Rapid Reboot - Compression Recovery Boots, Compression Recovery Systems & Boots | Rapid Reboot, Rapid Reboot Compression Boots - Recovery System, Amazon.com: Rapid Reboot Compression Boots

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Rapid Reboot Recovery Products, LLC

Sources (1)

  • FDA 510(k) K182668 24 fields · synced Sep 24, 2026