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AWQ-104L

TENS PLUS INDUSTRIAL COMPANY · Model ED3923 · UDI-DI 14897076720016

GZJ Prescription

510(k) clearances

503

Adverse events (4 deaths)

Recalls

188

Facilities

Description

The AWQ-104L w L-Digital Meter is the latest improved version of the multipurpose WQ-10 electro-therapy series from China, now with 4 outputs and large 0.5" x 0.9" LCD digital meter. The AWQ-104L is able to display and fine tune frequency selection through two separate ranges: 1 to 100 Hz (low) and 10 to 1,000 Hz (High). Unit also features: 4 independently controlled output channels which provide stimulation to 8 needles, polarity reversal [i.e. tonification (+) and sedation (-)] switches for each channel, Hi/Low voltage switch, and 2 frequency ranges (X1, X10). New integrated circuitry assures no interference or crossover. The AWQ-104L is also capable of delivering micro-current when the intensity is set just below the sensorial threshold level. Powered by 9 volt battery. Three adjustable pulse modes are also offered: continuous, intermittent (discontinuous), and dense-disperse. Accessories include 5" long pen shaped treatment probe with hand ground pole and wire, 4 sets of alligator clip wires, sturdy carrying case, 9-volt battery, and instructions. 1-year warranty from date of purchase.

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.