Cleared Traditional

K203552 - Rapid Reboot

K203552 is the FDA 510(k) clearance for Rapid Reboot 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 18-day FDA review.

K203552 · Rapid Reboot Recovery Products, LLC · Physical Medicine device
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Dec 2020
Decision
18d
Days
Class 2
Risk

K203552 is an FDA 510(k) clearance for the Rapid Reboot. 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 22, 2020 after a review of 18 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 K203552 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 04, 2020
Decision Date December 22, 2020
Days to Decision 18 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
97d faster than avg
Panel avg: 115d · This submission: 18d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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

Regulatory Technology Services, LLC
Prithul Bom

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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Related FDA 510(k) Regulatory Insights

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.