K243177
- 510(k) number
- K243177
- Device name
- SACS PRO
- Applicant
- Elastimed , Ltd. IL
- Product code
- IRP — Massager, Powered Inflatable Tube
- Decision date
- 2024-12-23
- Date received
- 2024-09-30
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Physical Medicine
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K243177.pdf
Official FDA record: K243177
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.