The following data is part of a premarket notification filed by Lorenz Biotech S.p.a. with the FDA for Lorenz Biotech Aptiva, Version 2.13.
| Device ID | K061828 |
| 510k Number | K061828 |
| Device Name: | LORENZ BIOTECH APTIVA, VERSION 2.13 |
| Classification | Stimulator, Nerve, Transcutaneous, For Pain Relief |
| Applicant | LORENZ BIOTECH S.P.A. 49 PLAIN STREET North Attleboro, MA 02760 |
| Contact | Rosina Robinson |
| Correspondent | Rosina Robinson LORENZ BIOTECH S.P.A. 49 PLAIN STREET North Attleboro, MA 02760 |
| Product Code | GZJ |
| Subsequent Product Code | HCC |
| Subsequent Product Code | IKN |
| Subsequent Product Code | JXE |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-06-28 |
| Decision Date | 2007-08-24 |
| Summary: | summary |