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PRISMA EMS MODULE

DEKA M.E.L.A. SRL · Model F55201 · UDI-DI 08034108512730

NGX Prescription

510(k) clearances

Adverse events

Recalls

207

Facilities

Description

The PRISMA EMS MODULE device consists of a main unit that generates electrical pulses and delivers rectangular biphasic waveforms via electrodes incorporated in an EMS applicator connected to the main unit. The delivery of the electrical energy is controlled by a footswitch. The PRISMA EMS MODULE is provided with an applicator to perform EMS (Electrical Muscle Stimulation). The applicator is provided with two different tips: Large and Medium, used to treat areas having different sizes, which include 3 stainless-steel equidistant electrodes. The Applicator is directly applied on the area to be treated and moved by the operator across the skin.

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.