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FDA 510(k)

Rapid Reboot Compression Therapy System

K-Number: K182668 · 2018-12-14

Decision Date2018-12-14
Product CodeIRP
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

Rapid Reboot Compression Therapy System is the device name listed in this FDA 510(k) record. The listed applicant is Rapid Reboot Recovery Products, LLC. It received FDA 510(k) clearance on 2018-12-14 under 510(k) number K182668. The device is classified under product code IRP. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Rapid Reboot Compression Therapy System?

Rapid Reboot Compression Therapy System is a medical device that received FDA 510(k) clearance on 2018-12-14. The listed applicant is Rapid Reboot Recovery Products, LLC. The 510(k) number is K182668.

When did Rapid Reboot Compression Therapy System receive FDA 510(k) clearance?

Rapid Reboot Compression Therapy System received FDA 510(k) clearance on 2018-12-14, under 510(k) number K182668.

Who is the listed applicant for Rapid Reboot Compression Therapy System?

The FDA 510(k) record lists Rapid Reboot Recovery Products, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Rapid Reboot Compression Therapy System?

The FDA product code for Rapid Reboot Compression Therapy System is IRP.

Other records listing Rapid Reboot Recovery Products, LLC as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Related Devices (Code: IRP)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Official Source

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