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Pointer-Plus

TENS PLUS INDUSTRIAL COMPANY · Model ED3332 · UDI-DI 14897076720047

GZJ Prescription
1
510(k) clearances
503
Adverse events (4 deaths)
7
Recalls
188
Facilities

Description

Pointer-Plus - Locator/Stim is a complete clinic in your hands. Modern, hand held, 6.5" long unit offers accurate acupuncture point stimulation with adjustable intensity dial. The pulse frequency is fixed at 10 Hz. The grounding circuit is made by holding the metal plate on the side of the unit or with the hand grounding pole. Accessories include 2 probe tips (ear 2 mm 0.08" and body 4 mm 0.16"), hand grounding pole with attached wire, 9 volt battery, carrying case, and instructions.

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.