K191436 is an FDA 510(k) clearance for the Saalio. This device is classified as a Device, Iontophoresis, Other Uses (Class II - Special Controls, product code EGJ).
Submitted by Saalmann Medical GmbH & Co. KG (Bad Oeynhausen, DE). The FDA issued a Cleared decision on October 18, 2019, 141 days after receiving the submission on May 30, 2019.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5525.
| 510(k) Number | K191436 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 30, 2019 |
| Decision Date | October 18, 2019 |
| Days to Decision | 141 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | Summary PDF |
| Product Code | EGJ - Device, Iontophoresis, Other Uses |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 890.5525 |