Reletex
RELIEFBAND TECHNOLOGIES LLC · Model PCN3 · UDI-DI 00661168300014
Description
Reletex from Reliefband is a prescription device that is applied to the underside of the wrist. Reletex emits electrical pulses that stimulate the underlying median nerve. These generated neural pulses interact with the CNS and Emetic Center in the brain to modulate the signals causing nausea and vomiting. It is intended for use as: (1) a treatment of nausea and vomiting (NV) due to chemotherapy; (2) a treatment of nausea and vomiting due to pregnancy (NVP) or morning sickness; and (3) an adjunct to antiemetics in reducing post-operative nausea. Reletex can function with its included set of non-replaceable/non-rechargeable batteries for approximately 150 hours when used on setting 3. In all such instances, Reletex is for single-patient 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. |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docs