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Johari Digital Healthcare Ltd.

SYRMA JOHARI MEDTECH LIMITED · Model MyoBody XT · UDI-DI 08908008085475

NGX
1
510(k) clearances
100
Adverse events
3
Recalls
214
Facilities

Description

"MyoBody XT is a sleek, multifunctional colored touch screen LCD desktop device. The device provides electrical muscle stimulation, interferential muscle stimulation, premod stimulation through four outputs. User can easily select any of the modes by one touch through the colored touch screen LCD display which displays selectable treatments, outputs, treatment time and intensity (that is controlled by a large knob) with START, STOP and PAUSE buttons. The colors of the screen and the buttons in it reflect whether the treatment is going on while constantly displaying the balance treatment time. intensity (that is controlled by a large knob) with START, STOP and PAUSE buttons. The colors of the screen and the buttons in it reflect whether the treatment is going on while constantly displaying the balance treatment time. "

Recalls

DateFirmReason
2021-01-13BEMER INT. AGThere 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.
2013-05-23Pinook-UsaFailure to submit a premarket submission and gain approval of a medical device.
2013-05-23Pinook-UsaFailure 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.