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Bio Protech
BIO PROTECH USA, INC. · Model MaxTens 1k · UDI-DI 00817120020005
GZJ
Prescription
1
510(k) clearances
500
Adverse events (4 deaths)
7
Recalls
186
Facilities
Description
MaxTens 1k - Analog Tens Unit
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.