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NXPro

Neux Technologies, Inc. · Model NXPro · UDI-DI 00199284950719

NGX

510(k) clearances

Adverse events

Recalls

207

Facilities

Description

The NXPro is an FDA-cleared, Class II, over-the-counter medical device that can be sold directly to healthy consumers without a prescription. This means any healthy individual (free from designated contraindications) can purchase and use this device on themselves or other health individuals for muscle conditioning, ensuring adequate safety and effectiveness in delivering advanced neuromuscular stimulation.

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.