K220538 is an FDA 510(k) clearance for the DolorClast Radial. This device is classified as a Massager, Therapeutic, Electric (Class I - General Controls, product code ISA).
Submitted by E.M.S Electro Medical Systems S.A (Nyon, CH). The FDA issued a Cleared decision on July 11, 2022, 136 days after receiving the submission on February 25, 2022.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5660.
| 510(k) Number | K220538 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 25, 2022 |
| Decision Date | July 11, 2022 |
| Days to Decision | 136 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | Summary PDF |
| Product Code | ISA — Massager, Therapeutic, Electric |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 890.5660 |