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Reliefband® Conductivity Gel

RELIEFBAND TECHNOLOGIES LLC · Model GP-1 · UDI-DI 00661168190011

GZJ

510(k) clearances

507

Adverse events (4 deaths)

Recalls

188

Facilities

Description

Reliefband Conductivity Gel for use with Reliefband devices. Each tube contains 7.5 mL (0.25 oz) of hypoallergenic conductivity gel. Reliefband Conductivity Gel improves effectiveness of Reliefband devices, keeping nerve stimulation active to control nausea and vomiting associated with motion sickness, morning sickness, chemotherapy and postoperative.

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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Data 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.