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miha bodytec

miha bodytec GmbH · Model miha bodytec II · UDI-DI 04260646650007

NGX IPF Prescription

510(k) clearances

Adverse events

Recalls

207

Facilities

Description

miha bodytec II is a machine with electronic muscle stimulation based on EMS technology. Regarding its use, the device is specifically designed as an addition to other sports and for training muscles.

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.