510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN

Tonica Elektronik a/S

FARUM Hovedstaden, DK

TONICA ELEKTRONIK A/S appears in FDA device records in FARUM Hovedstaden, DK. FDA records list 18 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
18
PMA records
0
Recall records
0
Registered establishments
1

510(k) clearance history

FDA records hold 18 510(k) clearances for Tonica Elektronik a/S between 2006 and 2026. The busiest year on record is 2017, with 5. The most recent is 2026, with 1.

Clearances by year, as a table
510(k) clearance decisions for Tonica Elektronik a/S, by decision year
YearClearances
20061
20071
20101
20151
20161
20175
20181
20201
20232
20253
20261
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K260189MagVenture Accelerated TMS (aTMS) Therapy SystemOBPSubstantially Equivalent
K251125MagVenture TMS Therapy SystemOBPSubstantially Equivalent
K251119MagVenture TMS Therapy SystemOBPSubstantially Equivalent
K252032T65 (9016E061-)OBPSubstantially Equivalent
K230014MagVenture Pain Therapy: MagPro R30, MagPro R30 with MagOption, MagPro X100, MagPro X100 with MagOptionQPLSubstantially Equivalent
K221544MagVenture TMS Atlas Neuro Navigation SystemHAWSubstantially Equivalent
K193006MagVenture TMS Therapy – for treatment of OCD, MagVenture TMS Therapy systemQCISubstantially Equivalent
K173620Mag Vita TMS Therapy System w/Theta Burst StimulationOBPSubstantially Equivalent
K172667MagVita TMS Therapy w/MagPro R20OBPSubstantially Equivalent
K171967MagVita TMS Therapy SystemOBPSubstantially Equivalent
K171481MagVita TMS Therapy SystemOBPSubstantially Equivalent
K170114MagVita TMS Therapy - w/MagPro R20OBPSubstantially Equivalent
K162873MEP MonitorGWFSubstantially Equivalent
K160280MagPro R20GWFSubstantially Equivalent
K150641MagVita TMS Therapy SystemOBPSubstantially Equivalent
K091940MAGPRO, MODELS R30 WITH MAGOPTION, X100, X100 WITH MAGOPTIONGWFSubstantially Equivalent
K071821COILS, MODELS MCF-B65, MCF-75, MCF-125 AND COOL-B65GWFSubstantially Equivalent
K061645MAGPRO, MODEL R30GWFSubstantially Equivalent

Registered establishments

FDA registered establishments for Tonica Elektronik a/S, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30055452163005545216TONICA ELEKTRONIK A/SLUCERNEMARKEN 15, FARUM Hovedstaden 3520 DK2026

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

Verification record

There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.

Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.

What MDM checks, and what it does not

MDM coverage

MDM coverage of this company lists here, newest first. Submit news.

Is this your company?

This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.

Claiming lets Tonica Elektronik a/S edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.

Claim this page

Data as of , FDA export datePage updated Source: openFDA, public domain