The following data is part of a premarket notification filed by Ems Electro Medical Systems Sa with the FDA for Dolorclast Radial.
| Device ID | K220538 |
| 510k Number | K220538 |
| Device Name: | DolorClast Radial |
| Classification | Massager, Therapeutic, Electric |
| Applicant | EMS Electro Medical Systems SA Ch. De La Vuarpilliere 31 Nyon, CH 1260 |
| Contact | Timothée Deblock |
| Correspondent | Sheila Hemeon-Heyer Heyer Regulatory Solutions LLC 125 Cherry Lane Amherst, MA 01002 |
| Product Code | ISA |
| CFR Regulation Number | 890.5660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-02-25 |
| Decision Date | 2022-07-11 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613353226053 | K220538 | 000 |
| 07613353187101 | K220538 | 000 |