Rapid2 Magnetic Stimulators (Magstim Rapid2, Magstim Super Rapid2, Magstim Super Rapid2 Plus1)
FDA 510(k) clearance K250286 · decided 2025-07-03
Clearance details
- K-number
- K250286
- Device name
- Rapid2 Magnetic Stimulators (Magstim Rapid2, Magstim Super Rapid2, Magstim Super Rapid2 Plus1)
- Applicant
- The Magstim Company Limited
- Decision
- Substantially Equivalent
- Date received
- 2025-01-31
- Decision date
- 2025-07-03
- Days to decision
- 153 days
- Clearance type
- Traditional
- Product code
- QPL
- Device class
- 2
- Regulation number
- 882.5890
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Carmarthenshire, GB
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.