← Product Code [IRO](/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IRO) · K931637

# A013 FEMI-FORM FACIAL MASSAGER (K931637)

_Fairform Mfg., Co., Ltd. · IRO · Mar 28, 1994 · Physical Medicine · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IRO/K931637

## Device Facts

- **Applicant:** Fairform Mfg., Co., Ltd.
- **Product Code:** [IRO](/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IRO.md)
- **Decision Date:** Mar 28, 1994
- **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.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IRO/K931637](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IRO/K931637)

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