K972093 is an FDA 510(k) clearance for the REGENESIS MODEL 42. 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. (Rockville, US). The FDA issued a Cleared decision on October 21, 1997, 139 days after receiving the submission on June 4, 1997.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5290.
| 510(k) Number | K972093 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 04, 1997 |
| Decision Date | October 21, 1997 |
| Days to Decision | 139 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 |