Cleared Traditional

K243775 - True Non-Surgical Spinal Decompression ...

K243775 is an FDA 510(k) clearance for True Non-Surgical Spinal Decompression ..., manufactured by Excite Medical of Tampa Bay, LLC. The device is a Class 2 Physical Medicine device with product code ITH cleared through the Traditional 510(k) pathway after a 221-day FDA review.

K243775 · Excite Medical of Tampa Bay, LLC · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2025
Decision
221d
Days
Class 2
Risk

K243775 is an FDA 510(k) clearance for the True Non-Surgical Spinal Decompression System (DRX9000-SL). Classified as Equipment, Traction, Powered (product code ITH), Class II - Special Controls.

Submitted by Excite Medical of Tampa Bay, LLC (Tampa, US). The FDA issued a Cleared decision on July 18, 2025 after a review of 221 days - an extended review cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5900 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Physical Medicine review framework, consistent with the majority of Class II 510(k) submissions.

View all Excite Medical of Tampa Bay, LLC devices

FDA 510(k) Submission Details - K243775

510(k) Number K243775 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 09, 2024
Decision Date July 18, 2025
Days to Decision 221 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
106d slower than avg
Panel avg: 115d · This submission: 221d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ITH Device Classification - Class 2, Special Controls

Product Code ITH Equipment, Traction, Powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5900
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

Cofactor Technologies, Inc.
Jon Werner

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 - ITH Equipment, Traction, Powered

All 10
Devices cleared under the same product code (ITH) and FDA review panel - the closest regulatory comparables to K243775.
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c1Trac
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