FDA 510(k) clearance · back to tracker

True Non-Surgical Spinal Decompression System (DRX9000-SL)

Excite Medical of Tampa Bay, LLC cleared K243775 on 2025-07-18, decision: substantially equivalent

K-number

K243775

Sponsor

Excite Medical of Tampa Bay, LLC

Device

True Non-Surgical Spinal Decompression System (DRX9000-SL)

Class

Class II

Decision

Substantially Equivalent

Decision date

2025-07-18

Product code

ITH

Advisory committee

Physical Medicine

Medical specialty

Physical Medicine

Regulation number

890.5900

Official FDA record

Open K243775on accessdata.fda.gov →

FDA's authoritative 510(k) summary page. Includes the decision letter, predicate references, and downloadable substantial-equivalence determination.

openFDA JSON

Raw record →

Machine-readable JSON. Useful for cross-referencing classification, product code, and advisory committee fields.

Use this as a predicate

Drop K243775 into Compass and start a substantial-equivalence draft.

Compass pulls the predicate's intended use, technological characteristics, and performance data, maps them against your device, and produces a draft SE table aligned to FDA's 510(k) program guidance.

Try the sandbox

Source

Public 510(k) database, U.S. Food and Drug Administration, accessed via openFDA. Page refreshed weekly.