The following data is part of a premarket notification filed by Media Plus, Llc with the FDA for Silverwear Silver Pro Garment Device.
| Device ID | K171798 |
| 510k Number | K171798 |
| Device Name: | Silverwear Silver Pro Garment Device |
| Classification | Electrode, Cutaneous |
| Applicant | Media Plus, LLC 560 Sylvan Aveue, 3rd Floor Englewood Cliffs, NJ 07632 |
| Contact | Rita Vacco |
| Correspondent | Sharon Blinkoff Locke Lord LLP 200 Vesey Street New York, NY 10281 |
| Product Code | GXY |
| CFR Regulation Number | 882.1320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-06-16 |
| Decision Date | 2018-06-01 |
| Summary: | summary |