K092791 is an FDA 510(k) clearance for the KNEEHAB XP CONTROLLER, MODEL 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 December 30, 2009, 110 days after receiving the submission on September 11, 2009.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5850.
| 510(k) Number | K092791 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 11, 2009 |
| Decision Date | December 30, 2009 |
| Days to Decision | 110 days |
| Submission Type | Special |
| 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 |