← Product Code [IRP](/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IRP) · K252396

# Cryo Sport 2.0 (AVA 501) (K252396)

_Avanutri Equipamentos DE Saúde · IRP · May 29, 2026 · Physical Medicine · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IRP/K252396

## Device Facts

- **Applicant:** Avanutri Equipamentos DE Saúde
- **Product Code:** [IRP](/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IRP.md)
- **Decision Date:** May 29, 2026
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 890.5650
- **Device Class:** Class 2
- **Review Panel:** Physical Medicine

## Regulatory Identification

A powered inflatable tube massager is a powered device intended for medical purposes, such as to relieve minor muscle aches and pains and to increase circulation. It simulates kneading and stroking of tissues with the hands by use of an inflatable pressure cuff.

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**Source:** [https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IRP/K252396](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IRP/K252396)

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