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Reliefband® Classic

RELIEFBAND TECHNOLOGIES LLC · Model 1.5 · UDI-DI 00661168600015

GZJ

510(k) clearances

507

Adverse events (4 deaths)

Recalls

188

Facilities

Description

Reliefband® Classic is a digital therapeutic device incorporated into a wristband which has a stimulating electrode that is worn on the underside of the wrist. It provides relief from nausea and vomiting through gentle electrical stimulation of the median nerve. Batteries will last approximately 150 hours of active use at power level 3 or below. The batteries of Reliefband® are user replaceable. Replace batteries in unit when they become drained.

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.