Browse hierarchy: [Physical Medicine (PM)](/submissions/PM) → [Subpart F — Physical Medicine Therapeutic Devices](/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices) → [21 CFR 890.5660](/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/890.5660) → MWZ — Expander, Breast, External

# MWZ · Expander, Breast, External

_Physical Medicine · 21 CFR 890.5660 · Class 1_

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

## Overview

- **Product Code:** MWZ
- **Device Name:** Expander, Breast, External
- **Regulation:** [21 CFR 890.5660](/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/890.5660)
- **Device Class:** 1
- **Review Panel:** [Physical Medicine](/submissions/PM)

## Identification

A therapeutic massager is an electrically powered device intended for medical purposes, such as to relieve minor muscle aches and pains.

## Classification Rationale

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 890.9.

## Recent Cleared Devices (1 of 1)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K770082](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/MWZ/K770082.md) | SALONMAY BUSTLINE INCREASER | Gamma Enterprises, Inc. | Mar 16, 1977 | SESE |

## Top Applicants

- Gamma Enterprises, Inc. — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/MWZ](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/MWZ)

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