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actiTENS

SUBLIMED · Model actiTENS standard kit · UDI-DI 03770018808239

GZJ IPF NGX NYN Prescription

510(k) clearances

500

Adverse events (4 deaths)

Recalls

186

Facilities

Description

actiTENS is a transcutaneous electrical nerve stimulation (TENS) medical device designed to manage chronic pain. The compact design and flexible shape of the actiTENS electrical impulse generator allows to fix it for daily use directly to the body of the patient. The impulse generator is delivered with a separate cradle which allows safely recharging its non- removable battery. The actiTENS is compatible with a selection of disposable electrodes and compatible connector cables transmit the electrical stimulation impulses to the targeted nerves according to the selected therapy. The electrical stimulation waveforms are biphasic and asymmetric. The actiTENS is controlled via a downloadable mobile app which allows the comfortable and simple selection of the adequate stimulation program. The actiTENS is intended to be used by the patient at home and also for therapeutic application by medical professionals. It is available for prescription only.

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.