The following data is part of a premarket notification filed by Storz Medical Ag with the FDA for D-actor 200 Vibration Massage System.
| Device ID | K173692 |
| 510k Number | K173692 |
| Device Name: | D-Actor 200 Vibration Massage System |
| Classification | Massager, Therapeutic, Electric |
| Applicant | Storz Medical AG Lohstampfestrasse 8 Tägerwilen, CH Ch-8274 |
| Contact | Pavel Novak |
| Correspondent | Michael Dayton Biomed Research, Inc. 3959 Van Dyke Road Suite 245 Lutz, FL 33558 |
| Product Code | ISA |
| CFR Regulation Number | 890.5660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-12-01 |
| Decision Date | 2018-04-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07630039101121 | K173692 | 000 |
| 07630039101060 | K173692 | 000 |
| 07630039101039 | K173692 | 000 |
| 07630039101008 | K173692 | 000 |
| 07630039101169 | K173692 | 000 |
| 07630039101343 | K173692 | 000 |
| 07630039101404 | K173692 | 000 |