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AUVON

Shenzhen Yuwen E-Commerce Co., Ltd. · Model AS1080-145 · UDI-DI 06971292000457

NGX NUH

510(k) clearances

100

Adverse events

Recalls

214

Facilities

Description

Adhesive electrodes are intended for use as the disposable, conductive adhesive interface between the patient’s skin and the Electrical Stimulator. Adhesive Electrodes are intended to be used with marketed Electrical Stimulators, i.e. TENS (Transcutaneous Electrical Nerve Stimulation) and EMS (Electrical Muscular Stimulation). It is for OTC use.

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.