510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K230014Substantially Equivalent

MagVenture Pain Therapy: MagPro R30, MagPro R30 with MagOption, MagPro X100, MagPro X100 with MagOption

Tonica Elektronik a/S, Farum, DK / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K230014 is the FDA 510(k) clearance record for MagVenture Pain Therapy: MagPro R30, MagPro R30 with MagOption, MagPro X100, MagPro X100 with MagOption, a class II device, cleared for Tonica Elektronik A/S on under FDA product code QPL (Electromagnetic Stimulator, Pain Relief). FDA's definition for product code QPL reads: "Intended to apply a magnetic-field induced electrical current to treat pain". FDA records list 18 510(k) clearances for Tonica Elektronik A/S, from to . As of , FDA records show no recalls naming K230014.

Clearance record

Decision date
Received
(234 days to decision)
Product code
QPL Electromagnetic Stimulator, Pain Relief
Regulation
21 CFR 882.5890
Device class
Class II
Review panel
Neurology
Applicant
Tonica Elektronik A/S Lucernemarken 15, Farum, DK
510(k) summary
Summary PDF
Third party review
No

Clearances, product code QPL

Trailing 12 months

FDA records hold no clearances under product code QPL in the trailing twelve months.

FDA records show no clearances under product code QPL in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code QPL, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260