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TENSCARE LIMITED · Model Perfect EMS · UDI-DI 05033435131419

NGX NUH

510(k) clearances

Adverse events

Recalls

207

Facilities

Description

Perfect EMS is a hand-held, home-use device designed to relief of pain and improve and facilitate muscle performance. Perfect EMS is intended for over-the-counter use. The device is battery powered, two channels home use neuromuscular stimulation. The device is supplied with self-adhesive electrodes which connect to the control unit by cable and plug and are placed on patients’ intact skin by the end user. Electrical stimulation is delivered via self-adhesive electrodes to nerves and muscles. The level of electrical stimulation is easily controlled by the end user using manual, push-button controls. The unit is intended for home use by the patient, and is designed with simplicity and ease of use in mind. It has six preset treatment programs and four manually adjustable programmes are available.

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.