FDA product code QPL: Electromagnetic Stimulator, Pain Relief
QPL is the FDA product code for electromagnetic stimulator, pain relief. It is a Class II device, regulated under 21 CFR 882.5890 and reviewed by the Physical Medicine panel. FDA has cleared 6 510(k) submissions under QPL, 5 in the last five years, from 5 different applicants. The average 510(k) review took 185 days (median 172); 153 days on average over the last three years.
Definition
Intended to apply a magnetic-field induced electrical current to treat pain.
Classification
| Field | Value |
|---|---|
| Device name | Electromagnetic Stimulator, Pain Relief |
| Device class | Class II |
| Regulation | 21 CFR 882.5890 |
| Review panel | PM — Physical Medicine |
| Medical specialty | Neurology |
| Premarket route | 510(k) |
510(k) clearances per year for QPL
| Year | Clearances | Avg. review days |
|---|---|---|
| 2021 | 1 | 158 |
| 2023 | 1 | 234 |
| 2024 | 1 | 100 |
| 2025 | 3 | 206 |
Compare with all 510(k) review times · Search every QPL clearance
Top QPL applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Neuralace Medical, Inc. | 2 | 2024-01-10 |
| BTL Industries, Inc. | 1 | 2025-08-07 |
| The Magstim Company Limited | 1 | 2025-07-03 |
| Fotona D.O.O. | 1 | 2025-03-27 |
| Tonica Elektronik A/S | 1 | 2023-08-25 |
Most recent QPL clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K250309 | BTL Industries, Inc. | BTL-199 | 2025-08-07 | 185 |
| K250286 | The Magstim Company Limited | Rapid2 Magnetic Stimulators (Magstim Rapid2, Magstim Super Rapid2, Magstim Super Rapid2 Plus1) | 2025-07-03 | 153 |
| K241785 | Fotona D.O.O. | StarFormer (M008-3T) | 2025-03-27 | 280 |
| K233364 | Neuralace Medical, Inc. | Axon Therapy | 2024-01-10 | 100 |
| K230014 | Tonica Elektronik A/S | MagVenture Pain Therapy: MagPro R30, MagPro R30 with MagOption, MagPro X100, MagPro X100 with MagOption | 2023-08-25 | 234 |
Recalls for QPL devices
openFDA lists no recalls for product code QPL.
Frequently asked questions
What is FDA product code QPL?
QPL is the FDA product code for electromagnetic stimulator, pain relief. It is a Class II device, regulated under 21 CFR 882.5890 and reviewed by the Physical Medicine panel.
What device class is QPL?
Class II, regulation 21 CFR 882.5890. Typical premarket route: 510(k).
How long does a 510(k) take for product code QPL?
Across 6 cleared submissions the average was 185 days from receipt to decision (median 172).
Which companies have the most QPL clearances?
Neuralace Medical, Inc. (2); BTL Industries, Inc. (1); The Magstim Company Limited (1); Fotona D.O.O. (1); Tonica Elektronik A/S (1).
Next steps
- Run an FDA pathway report with predicate devices for product code QPL
- Run a recall and safety report across every QPL manufacturer
- Watch product code QPL for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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