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EMS

Canadian Pioneer Medical Technology Corporation · Model MagnaCore · UDI-DI 00199284910331

NGX

510(k) clearances

Adverse events

Recalls

207

Facilities

Description

MagnaCore is a non-invasive EMS device that uses electromagnetic pulses to strengthen and tone muscles. It targets areas such as the abdomen, thighs, and buttocks with preset intensity protocols.

Recalls

Date	Firm	Reason
2021-01-13	BEMER INT. AG	There potential that electromagnetic fields generated in the therapy system may cause technical defects in a patient using an insulin pumps or a malfunction of a pacemaker.
2013-05-23	Pinook-Usa	Failure to submit a premarket submission and gain approval of a medical device.
2013-05-23	Pinook-Usa	Failure to submit a premarket submission and gain approval of a medical device.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.