Electromagnetic Stimulator, Pain Relief
The Electromagnetic Stimulator for Pain Relief is a neurology device intended to apply a magnetic field-induced electrical current to treat pain, using electromagnetic energy delivered to targeted tissues as a non-pharmacological pain management approach. This device is classified as FDA Class 2, requiring 510(k) clearance, under regulation 882.5890 in the Neurology specialty (reviewed by the Physical Medicine panel). It carries product code QPL and is not an implant and not life-sustaining.
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Basic Information
- Product Code
- QPL
- Device Class
- FDA class 2
- Regulation Number
- 882.5890
- Medical Specialty
- Neurology
- Review Panel
- PM
- Submission Type
- 1
Device Characteristics
Definition
Intended to apply a magnetic-field induced electrical current to treat pain.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 6 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K250309 | BTL-199 | Aug 07, 2025 | Substantially Equivalent | BTL Industries, Inc. |
| K250286 | Rapid2 Magnetic Stimulators (Magstim Rapid2, Magstim Super Rapid2, Magstim Super Rapid2 Plus1) | Jul 03, 2025 | Substantially Equivalent | The Magstim Company Limited |
| K241785 | StarFormer (M008-3T) | Mar 27, 2025 | Substantially Equivalent | Fotona D.O.O. |
| K233364 | Axon Therapy | Jan 10, 2024 | Substantially Equivalent | Neuralace Medical, Inc. |
| K230014 | MagVenture Pain Therapy: MagPro R30, MagPro R30 with MagOption, MagPro X100, MagPro X100 with MagOption | Aug 25, 2023 | Substantially Equivalent | Tonica Elektronik A/S |
| K210021 | Axon Therapy | Jun 11, 2021 | Substantially Equivalent | Neuralace Medical, Inc. |
FEI Numbers
This FDA classification entry is associated with 7 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 7 registration numbers. Click on an entry to view related FDA registrations.