← Product Code [ISA](/productcode/ISA) · K832913

# BACK MASSAGER B-400 ADJUSTABLE (K832913)

_Pollenex Associated Mills, Inc. · ISA · Nov 7, 1983 · Physical Medicine · SESE_

**Canonical URL:** https://fda-staging.innolitics.com/device/K832913

## Device Facts

- **Applicant:** Pollenex Associated Mills, Inc.
- **Product Code:** [ISA](/productcode/ISA.md)
- **Decision Date:** Nov 7, 1983
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 890.5660
- **Device Class:** Class 1
- **Review Panel:** Physical Medicine

## Regulatory Identification

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

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**Source:** [https://fda-staging.innolitics.com/device/K832913](https://fda-staging.innolitics.com/device/K832913)

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