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Z TECHNOLOGIES LLC · Model F7 · UDI-DI 00860000205191
GZJ
Prescription
1
510(k) clearances
503
Adverse events (4 deaths)
7
Recalls
188
Facilities
Description
TENS DEVICE The device is intended to be used by clinicians in symptomatic relief of chronic intractable pain. Also, for post traumatic and post surgical pain relief.
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.