K082011 is an FDA 510(k) clearance for the MEDISTIM XP, TYPE 281 AND MEDITENS XP, TYPE 458. 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 November 28, 2008, 136 days after receiving the submission on July 15, 2008.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5890.
| 510(k) Number | K082011 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 15, 2008 |
| Decision Date | November 28, 2008 |
| Days to Decision | 136 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 |