Browse hierarchy: [Physical Medicine (PM)](/submissions/PM) → [Subpart B — Physical Medicine Diagnostic Devices](/submissions/PM/subpart-b%E2%80%94physical-medicine-diagnostic-devices) → [21 CFR 890.1850](/submissions/PM/subpart-b%E2%80%94physical-medicine-diagnostic-devices/890.1850) → ISB — Stimulator, Muscle, Diagnostic

# ISB · Stimulator, Muscle, Diagnostic

_Physical Medicine · 21 CFR 890.1850 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/PM/subpart-b%E2%80%94physical-medicine-diagnostic-devices/ISB

## Overview

- **Product Code:** ISB
- **Device Name:** Stimulator, Muscle, Diagnostic
- **Regulation:** [21 CFR 890.1850](/submissions/PM/subpart-b%E2%80%94physical-medicine-diagnostic-devices/890.1850)
- **Device Class:** 2
- **Review Panel:** [Physical Medicine](/submissions/PM)
- **3rd-party reviewable:** yes

## Identification

A diagnostic muscle stimulator is a device used mainly with an electromyograph machine to initiate muscle activity. It is intended for medical purposes, such as to diagnose motor nerve or sensory neuromuscular disorders and neuromuscular function.

## Classification Rationale

Class II (performance standards).

## Recent Cleared Devices (5 of 5)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K842805](https://fda.innolitics.com/submissions/PM/subpart-b%E2%80%94physical-medicine-diagnostic-devices/ISB/K842805.md) | IMPULS 3, IT SELECTOR | Robert Bosch Corp. | Aug 1, 1984 | SESE |
| [K842262](https://fda.innolitics.com/submissions/PM/subpart-b%E2%80%94physical-medicine-diagnostic-devices/ISB/K842262.md) | PIRD-Y | Pirdy, Inc. | Jun 28, 1984 | SESE |
| [K790949](https://fda.innolitics.com/submissions/PM/subpart-b%E2%80%94physical-medicine-diagnostic-devices/ISB/K790949.md) | GALVANIC UNIT | Rami International Corp. | Aug 16, 1979 | SESE |
| [K780632](https://fda.innolitics.com/submissions/PM/subpart-b%E2%80%94physical-medicine-diagnostic-devices/ISB/K780632.md) | MAXICEPTOR | Med General | Aug 14, 1978 | SESE |
| [K780730](https://fda.innolitics.com/submissions/PM/subpart-b%E2%80%94physical-medicine-diagnostic-devices/ISB/K780730.md) | FIGURETRIM | Jay-Mar INternational Enterprises, IN | May 9, 1978 | SESE |

## Top Applicants

- Jay-Mar INternational Enterprises, IN — 1 clearance
- Med General — 1 clearance
- Pirdy, Inc. — 1 clearance
- Rami International Corp. — 1 clearance
- Robert Bosch Corp. — 1 clearance

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

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