MagVenture Pain Therapy: MagPro R30, MagPro R30 with MagOption, MagPro X100, MagPro X100 with MagOption
Summary
Tonica Elektronik A/S received 510(k) clearance for MagVenture Pain Therapy: MagPro R30, MagPro R30 with MagOption, MagPro X100, MagPro X100 with MagOption, a QPL device. Cleared on 2023-08-25.
Details
Source
510(k) Clearance
External ID
K230014
Action Date
2023-08-25
Status
Traditional
Category
device
Product Code
QPL
Product Description
MagVenture Pain Therapy: MagPro R30, MagPro R30 with MagOption, MagPro X100, MagPro X100 with MagOption. 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. Tonica Elektronik A/S has received 6 total clearances in our database.
Tonica Elektronik A/S has 6 FDA actions in our database, including 6 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 Tonica Elektronik A/S have FDA actions?
Tonica Elektronik A/S has 6 FDA actions in our database, including 0 recalls and 6 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K230014" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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