K112258 is an FDA 510(k) clearance for the NEUROTECH PLUS. This device is classified as a Stimulator, Nerve, Transcutaneous, For Pain Relief (Class II - Special Controls, product code GZJ).
Submitted by Bio-Medical Research, Ltd. (Galway, IE). The FDA issued a Cleared decision on January 9, 2012, 157 days after receiving the submission on August 5, 2011.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5890.
| 510(k) Number | K112258 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 05, 2011 |
| Decision Date | January 09, 2012 |
| Days to Decision | 157 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | GZJ — Stimulator, Nerve, Transcutaneous, For Pain Relief |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.5890 |