K922036 is an FDA 510(k) clearance for the SONOPULS 591. This device is classified as a Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat (Class II - Special Controls, product code IMG).
Submitted by Henley Intl. (Sugar Land, US). The FDA issued a Cleared decision on June 29, 1993, 424 days after receiving the submission on May 1, 1992.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5860.
| 510(k) Number | K922036 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 01, 1992 |
| Decision Date | June 29, 1993 |
| Days to Decision | 424 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | Statement |
| Product Code | IMG — Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 890.5860 |