K083105 is an FDA 510(k) clearance for the KNEEHAB XP CONDUCTIVE GARMENT, TYPE 411. This device is classified as a Stimulator, Muscle, Powered (Class II - Special Controls, product code IPF).
Submitted by Bio-Medical Research, Ltd. (Galway, IE). The FDA issued a Cleared decision on July 24, 2009, 277 days after receiving the submission on October 20, 2008.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5850.
| 510(k) Number | K083105 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 20, 2008 |
| Decision Date | July 24, 2009 |
| Days to Decision | 277 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | Summary PDF |
| Product Code | IPF — Stimulator, Muscle, Powered |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 890.5850 |