K091248 is an FDA 510(k) clearance for the MAXEMS, MODELS 1000 AND 2000. This device is classified as a Stimulator, Muscle, Powered (Class II - Special Controls, product code IPF).
Submitted by Bio Protech, Inc. (Dallas, US). The FDA issued a Cleared decision on November 30, 2009, 216 days after receiving the submission on April 28, 2009.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5850.
| 510(k) Number | K091248 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 28, 2009 |
| Decision Date | November 30, 2009 |
| Days to Decision | 216 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 |