QPL · Electromagnetic Stimulator, Pain Relief
Neurology · 21 CFR 882.5890 · Class 2
Overview
| Product Code | QPL |
|---|---|
| Device Name | Electromagnetic Stimulator, Pain Relief |
| Regulation | 21 CFR 882.5890 |
| Device Class | Class 2 |
| Review Panel | Neurology |
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 | BTL-199 | BTL Industries, Inc. | Aug 7, 2025 | SESE |
| K250286 | Rapid2 Magnetic Stimulators (Magstim Rapid2, Magstim Super Rapid2, Magstim Super Rapid2 Plus1) | The Magstim Company Limited | Jul 3, 2025 | SESE |
| K241785 | StarFormer (M008-3T) | Fotona D.O.O. | Mar 27, 2025 | SESE |
| K233364 | Axon Therapy | Neuralace Medical, Inc. | Jan 10, 2024 | SESE |
| K230014 | MagVenture Pain Therapy: MagPro R30, MagPro R30 with MagOption, MagPro X100, MagPro X100 with MagOption | Tonica Elektronik A/S | Aug 25, 2023 | SESE |
| K210021 | 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
