K240122
- 510(k) number
- K240122
- Device name
- Normatec Elite
- Applicant
- NormaTec Industries, LP MA · US
- Product code
- IRP — Massager, Powered Inflatable Tube
- Decision date
- 2024-03-21
- Date received
- 2024-01-16
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Physical Medicine
PDFDownload 510(k) SummaryArchived here · 1.5 MB · U.S. public domain
Also available from FDA: K240122.pdf
Official FDA record: K240122
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.