actiTENS
SUBLIMED · Model actiTENS armband - 40 cm · UDI-DI 03770018808093
1
510(k) clearances
507
Adverse events (4 deaths)
7
Recalls
185
Facilities
Description
The EIG can be held on the patient’s body using an armband close to the area to be stimulated. The armband is composed on its upper side of velvet VELCRO allowing the fixation of the EIG. They are reusable and machine washable by following the instructions on the instructions for use.
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.