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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
| Date | Firm | Reason |
|---|---|---|
| 2011-02-07 | Neuro Resource Group Inc | Product package contains alcohol prep pads recalled by Triad Group because the prep pads have the potential to be contaminated with an objectionable organism. |
| 2008-07-18 | Synaptic Corp | Device was distributed without marketing approval. |
| 2007-06-29 | Avazzia, Inc | Plastic Cases may crack due to manufacturing by the supplier not meeting specifications |
| 2007-06-29 | Avazzia, Inc | Plastic Cases may crack due to manufacturing by the supplier not meeting specifications |
| 2007-06-29 | Avazzia, Inc | Plastic Cases may crack due to manufacturing by the supplier not meeting specifications |
| 2007-06-29 | Avazzia, Inc | Plastic Cases may crack due to manufacturing by the supplier not meeting specifications |
| 2003-05-23 | Rehabilicare | If 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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Get your free API keyRead the docsData 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.
