← Product Code [IRP](/productcode/IRP) · K260948

# Air Compression Massager (EP30B001 I) (K260948)

_Wavepulse (Xiamen) Healthcare Technology Co., Ltd. · IRP · Jul 24, 2026 · Physical Medicine · SESE_

**Canonical URL:** https://fda.innolitics.com/device/K260948

## Device Facts

- **Applicant:** Wavepulse (Xiamen) Healthcare Technology Co., Ltd.
- **Product Code:** [IRP](/productcode/IRP.md)
- **Decision Date:** Jul 24, 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/device/K260948](https://fda.innolitics.com/device/K260948)

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