The following data is part of a premarket notification filed by Delta International Services & Logistics S.r.l with the FDA for Scrambler Therapy Technology (model St-5a).
| Device ID | K201458 |
| 510k Number | K201458 |
| Device Name: | Scrambler Therapy Technology (Model ST-5A) |
| Classification | Stimulator, Nerve, Transcutaneous, For Pain Relief |
| Applicant | Delta International Services & Logistics S.r.l Piazza Adriana 4 Rome, IT 00193 |
| Contact | Mariella Giorgieri |
| Correspondent | Mariella Giorgieri Delta International Services & Logistics S.r.l Piazza Adriana 4 Rome, IT 00193 |
| Product Code | GZJ |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-06-01 |
| Decision Date | 2020-12-23 |