← Product Code [IRO](/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IRO) · K946382

# SKALPI 3200 (K946382)

_Wiscco Development, Inc. · IRO · May 30, 1995 · Physical Medicine · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IRO/K946382

## Device Facts

- **Applicant:** Wiscco Development, Inc.
- **Product Code:** [IRO](/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IRO.md)
- **Decision Date:** May 30, 1995
- **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/K946382](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IRO/K946382)

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