K091317 is an FDA 510(k) clearance for the LUMBOFIX CONDUCTIVE GARMENT, MODEL 420 BACK. 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 June 25, 2009, 52 days after receiving the submission on May 4, 2009.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5890.
| 510(k) Number | K091317 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 04, 2009 |
| Decision Date | June 25, 2009 |
| Days to Decision | 52 days |
| Submission Type | Special |
| 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 |