← Product Code [IRO](/productcode/IRO) · K913439

# SONIX...THERAPEUTIC SONIC MASSAGE (K913439)

_Mcshirley Products, Inc. · IRO · Jan 22, 1992 · Physical Medicine · SESE_

**Canonical URL:** https://fda-staging.innolitics.com/device/K913439

## Device Facts

- **Applicant:** Mcshirley Products, Inc.
- **Product Code:** [IRO](/productcode/IRO.md)
- **Decision Date:** Jan 22, 1992
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 890.5975
- **Device Class:** Class 1
- **Review Panel:** Physical Medicine

## Regulatory Identification

A therapeutic vibrator is an electrically powered device intended for medical purposes that incorporates various kinds of pads and that is held in the hand or attached to the hand or to a table. It is intended for various uses, such as relaxing muscles and relieving minor aches and pains.

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**Source:** [https://fda-staging.innolitics.com/device/K913439](https://fda-staging.innolitics.com/device/K913439)

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