K243775
- 510(k) number
- K243775
- Device name
- True Non-Surgical Spinal Decompression System (DRX9000-SL)
- Applicant
- Excite Medical of Tampa Bay, LLC FL · US
- Product code
- ITH — Equipment, Traction, Powered
- Decision date
- 2025-07-18
- Date received
- 2024-12-09
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Physical Medicine
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K243775.pdf
Official FDA record: K243775
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.