← Product Code [IRO](/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IRO) · K771279

# HEAD FACILITATION VIBRATOR BK-5210 (K771279)

_Fred Sammons, Inc. · IRO · Aug 26, 1977 · Physical Medicine · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IRO/K771279

## Device Facts

- **Applicant:** Fred Sammons, Inc.
- **Product Code:** [IRO](/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IRO.md)
- **Decision Date:** Aug 26, 1977
- **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/K771279](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IRO/K771279)

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