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Reliefband® Premier Charcoal

RELIEFBAND TECHNOLOGIES LLC · Model 2.0 Charcoal · UDI-DI 00661168600022

GZJ

510(k) clearances

507

Adverse events (4 deaths)

Recalls

188

Facilities

Description

Reliefband® Premier Charcoal is a rechargeable, digital wearable device that is worn on the wrist. It consists of a hypoallergenic band with a control panel on top and two electrical contacts underneath. The two contacts must be placed firmly against the underside of your wrist at the P6 location. A fully charged battery will last for approximately 18 hours of continuous use at the mid-power level or below.

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.