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EmeTerm

WAT Medical Technology Inc. · Model YF-ZTY-E1 · UDI-DI 06971760280367

GZJ
1
510(k) clearances
500
Adverse events (4 deaths)
7
Recalls
186
Facilities

Description

TENS device-EmeTerm generates the electric pulses with highly specific waveforms, frequency and amplitude to stimulate the median nerve. The accurate pulse signals provide relief through electrical stimulation of the nerves in the patient’s wrist.

Recalls

DateFirmReason
2011-02-07Neuro Resource Group IncProduct package contains alcohol prep pads recalled by Triad Group because the prep pads have the potential to be contaminated with an objectionable organism.
2008-07-18Synaptic CorpDevice was distributed without marketing approval.
2007-06-29Avazzia, IncPlastic Cases may crack due to manufacturing by the supplier not meeting specifications
2007-06-29Avazzia, IncPlastic Cases may crack due to manufacturing by the supplier not meeting specifications
2007-06-29Avazzia, IncPlastic Cases may crack due to manufacturing by the supplier not meeting specifications
2007-06-29Avazzia, IncPlastic Cases may crack due to manufacturing by the supplier not meeting specifications
2003-05-23RehabilicareIf there was a short, excessive heat could have been generated in the transformer due to the use of the wrong fuse.

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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.