K252396
- 510(k) number
- K252396
- Device name
- Cryo Sport 2.0 (AVA 501)
- Applicant
- Avanutri Equipamentos DE Saúde BR
- Product code
- IRP — Massager, Powered Inflatable Tube
- Decision date
- 2026-05-29
- Date received
- 2025-07-31
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Physical Medicine
PDFDownload 510(k) SummaryArchived here · 1.0 MB · U.S. public domain
Also available from FDA: K252396.pdf
Official FDA record: K252396
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.