← Product Code [IPF](/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IPF) · K915230

# H WAVE MUSCLE STIMULATOR (K915230)

_Electronic Waveform Laboratory, Inc. · IPF · May 8, 1992 · Physical Medicine · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IPF/K915230

## Device Facts

- **Applicant:** Electronic Waveform Laboratory, Inc.
- **Product Code:** [IPF](/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IPF.md)
- **Decision Date:** May 8, 1992
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 890.5850
- **Device Class:** Class 2
- **Review Panel:** Physical Medicine

## Regulatory Identification

A powered muscle stimulator is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area.

---

**Source:** [https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IPF/K915230](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IPF/K915230)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com
