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ProActive Alevia 2 in 1 TENS

A.M.G. Médicale Inc · Model 715-425 · UDI-DI 00775757154251

NGX

510(k) clearances

Adverse events

Recalls

207

Facilities

Description

The TENS 2-in-1 Physiotherapy Alevia™ by ProActive™ is a 2-in-1 (TENS and EMS) device that gives you the ability to fully customize treatment options or choose one of the 18 pre-set programs. It has a large, easy-to-read LCD and includes all accessories. The Alevia™ comes complete with 4 self-adhesive, pre-gelled and reusable electrodes, one rechargeable battery with USB Cable, lead wires, instructions and a storage bag. ProActive™ offers a complete line of physiotherapy devices, clinically proven to relieve pain without drugs, including a full line-up of electrodes. The Alevia™ Dual channel TENS Electro-Stimulator relieves pain in 2 ways: TENS (Transcutaneous Nerve Stimulation) stimulates or numbs nerves EMS (Electrical Muscle Stimulation) prevents atrophy

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.