Rapid2 Magnetic Stimulators (Magstim Rapid2, Magstim Super Rapid2, Magstim Super Rapid2 Plus1)
Summary
The Magstim Company Limited received 510(k) clearance for Rapid2 Magnetic Stimulators (Magstim Rapid2, Magstim Super Rapid2, Magstim Super Rapid2 Plus1), a QPL device. Cleared on 2025-07-03.
Details
Source
510(k) Clearance
External ID
K250286
Action Date
2025-07-03
Status
Traditional
Category
device
Product Code
QPL
Product Description
Rapid2 Magnetic Stimulators (Magstim Rapid2, Magstim Super Rapid2, Magstim Super Rapid2 Plus1). Product code: QPL.
Company
Context & Analysis
A 510(k) clearance means the FDA determined this device is substantially equivalent to a legally marketed device. This is one of 403 device clearances issued this month. The Magstim Company Limited has received 3 total clearances in our database.
The Magstim Company Limited has 3 FDA actions in our database, including 3 clearances.
Frequently Asked Questions
What does 510(k) clearance mean?
A 510(k) is an FDA premarket submission demonstrating that a device is substantially equivalent to a legally marketed device. It does NOT mean FDA approval — it means the device is cleared for marketing because it's similar enough to an existing cleared device. Most medical devices reach market via 510(k) rather than full PMA approval.
How often does The Magstim Company Limited have FDA actions?
The Magstim Company Limited has 3 FDA actions in our database, including 0 recalls and 3 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K250286" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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