510(k) K250286
K250286 is an FDA 510(k) premarket notification submitted by The Magstim Company Limited for the device "Rapid2 Magnetic Stimulators (Magstim Rapid2, Magstim Super Rapid2, Magstim Super Rapid2 Plus1)". The FDA issued a decision of Substantially Equivalent on July 3, 2025. The device falls under product code QPL (Electromagnetic Stimulator, Pain Relief), a Class II device regulated under 21 CFR 882.5890. The Magstim Company Limited has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 3, 2025
- Date Received
- January 31, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Electromagnetic Stimulator, Pain Relief
- Device Class
- Class II
- Regulation Number
- 882.5890
- Review Panel
- PM
- Submission Type
Intended to apply a magnetic-field induced electrical current to treat pain.