Cryo Sport 2.0 (AVA 501)— 510(k) K252396
Substantially EquivalentAvanutri Equipamentos DE Saúde
FDA 510(k) clearance K252396 for Cryo Sport 2.0 (AVA 501), Substantially Equivalent on 2026-05-29. Applicant: Avanutri Equipamentos DE Saúde. Device class: 2.
Summary
The Cryo Sport 2.0 (AVA 501) comes from Avanutri Equipamentos DE Saúde and is filed under IRP, powered inflatable tube massagers.
Class II, 21 CFR 890.5650. Physical Medicine is both the classification panel and the review panel. It was a Traditional 510(k).
Avanutri filed from Tres Rios, Brazil. Review took 302 calendar days (July 31, 2025 to May 29, 2026).
Clearance details
- Applicant
- Avanutri Equipamentos DE Saúde
- Product code
- Product code IRP
- Device class
- Class 2
- Regulation
- 21 CFR 890.5650
- Advisory panel
- Physical Medicine
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Tres Rios, BR
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Data sourced from openFDA. This site is unofficial and independent of the FDA.