Browse hierarchy: [Neurology (NE)](/submissions/NE) → [Subpart F — Neurological Therapeutic Devices](/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices) → [21 CFR 882.5890](/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/882.5890) → QPL — Electromagnetic Stimulator, Pain Relief

# QPL · Electromagnetic Stimulator, Pain Relief

_Neurology · 21 CFR 882.5890 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/QPL

## Overview

- **Product Code:** QPL
- **Device Name:** Electromagnetic Stimulator, Pain Relief
- **Regulation:** [21 CFR 882.5890](/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/882.5890)
- **Device Class:** 2
- **Review Panel:** [Neurology](/submissions/NE)

## Identification

A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain.

## Classification Rationale

Class II (performance standards).

## Recent Cleared Devices (6 of 6)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K250309](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/QPL/K250309.md) | BTL-199 | BTL Industries, Inc. | Aug 7, 2025 | SESE |
| [K250286](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/QPL/K250286.md) | Rapid2 Magnetic Stimulators (Magstim Rapid2, Magstim Super Rapid2, Magstim Super Rapid2 Plus1) | The Magstim Company Limited | Jul 3, 2025 | SESE |
| [K241785](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/QPL/K241785.md) | StarFormer (M008-3T) | Fotona D.O.O. | Mar 27, 2025 | SESE |
| [K233364](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/QPL/K233364.md) | Axon Therapy | Neuralace Medical, Inc. | Jan 10, 2024 | SESE |
| [K230014](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/QPL/K230014.md) | MagVenture Pain Therapy: MagPro R30, MagPro R30 with MagOption, MagPro X100, MagPro X100 with MagOption | Tonica Elektronik A/S | Aug 25, 2023 | SESE |
| [K210021](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/QPL/K210021.md) | Axon Therapy | Neuralace Medical, Inc. | Jun 11, 2021 | SESE |

## Top Applicants

- Neuralace Medical, Inc. — 2 clearances
- BTL Industries, Inc. — 1 clearance
- Fotona D.O.O. — 1 clearance
- The Magstim Company Limited — 1 clearance
- Tonica Elektronik A/S — 1 clearance

---

**Source:** [https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/QPL](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/QPL)

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