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NeMa-st - soleve

LIGHTRAY-PLUS LTD · Model 3.3 · UDI-DI 07290019787013

GZJ Prescription

510(k) clearances

500

Adverse events (4 deaths)

Recalls

186

Facilities

Description

The NeMa-st - Soleve device is intended for Transcutaneous Electrical nerve Stimulation for back pain relief. NeMa-st - Soleve is indicated for the relief and management of symptomatic chronic or intractable back pain and/or post-surgical back pain and/or post trauma back pain. Soleve is designed to deliver electrical stimulation using small contact surface probes. It includes an array of 26 probes connected to a motion system, enabling the provision of electrical stimulation to multiple points in the back.

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.