K091791 is an FDA 510(k) clearance for the PROVANT SYSTEM, MODEL 4201. This device is classified as a Diathermy, Shortwave, For Use Other Than Applying Therapeutic Deep Heat (Class II - Special Controls, product code ILX).
Submitted by Regenesis Biomedical, Inc. (Scottsdale, US). The FDA issued a Cleared decision on April 7, 2010, 294 days after receiving the submission on June 17, 2009.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5290.
| 510(k) Number | K091791 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 17, 2009 |
| Decision Date | April 07, 2010 |
| Days to Decision | 294 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | Summary PDF |
| Product Code | ILX - Diathermy, Shortwave, For Use Other Than Applying Therapeutic Deep Heat |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 890.5290 |