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Electromagnetic Stimulator, Pain Relief
- Page Type
- Product Code
- Definition
- Intended to apply a magnetic-field induced electrical current to treat pain.
- Physical State
- The device comes in a variety of shapes and sizes. It generally includes a magnetic stimulator, a stimulation coil, a cooling system, and other accessories.
- Technical Method
- This device uses a magnetic coil to produce a time-varying magnetic field, which induces a secondary electric field in the targeted tissues which, in turn, non-invasively stimulates peripheral nerves and provides chronic nerve pain relief.
- Target Area
- This device generally targets peripheral nerves in lower and/or upper extremities and low back.
- Regulation Medical Specialty
- Neurology
- Review Panel
- Physical Medicine
- Submission Type
- 510(K)
- Device Classification
- Class 2
- Regulation Number
- 882.5890
- GMP Exempt?
- No
- Summary Malfunction Reporting
- Ineligible
- Implanted Device
- No
- Life-Sustain/Support Device
- No
- Third Party Review
- Not Third Party Eligible
- MAUDE Alerts
- View and Sign Up For MAUDE Alerts
CFR § 882.5890 Transcutaneous electrical nerve stimulator for pain relief
§ 882.5890 Transcutaneous electrical nerve stimulator for pain relief.
(a) 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.
(b) Classification. Class II (performance standards).