K100246 is an FDA 510(k) clearance for the MAX-IF1000. This device is classified as a Interferential Current Therapy (Class II - Special Controls, product code LIH).
Submitted by Bio Protech, Inc. (Dallas, US). The FDA issued a Cleared decision on November 24, 2010, 301 days after receiving the submission on January 27, 2010.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5890.
| 510(k) Number | K100246 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 27, 2010 |
| Decision Date | November 24, 2010 |
| Days to Decision | 301 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | LIH - Interferential Current Therapy |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.5890 |