K173692 is an FDA 510(k) clearance for the D-Actor 200 Vibration Massage System. This device is classified as a Massager, Therapeutic, Electric (Class I - General Controls, product code ISA).
Submitted by Storz Medical AG (Tagerwilen, CH). The FDA issued a Cleared decision on April 13, 2018, 133 days after receiving the submission on December 1, 2017.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5660.
| 510(k) Number | K173692 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 01, 2017 |
| Decision Date | April 13, 2018 |
| Days to Decision | 133 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 |