The following data is part of a premarket notification filed by Agar Ginosar Electronics with the FDA for Agarrelief 10 Transcutaneous Elec Nerve Stimulator.
| Device ID | K905526 |
| 510k Number | K905526 |
| Device Name: | AGARRELIEF 10 TRANSCUTANEOUS ELEC NERVE STIMULATOR |
| Classification | Stimulator, Nerve, Transcutaneous, For Pain Relief |
| Applicant | AGAR GINOSAR ELECTRONICS KIBBUTZ GINOSAR Ginosar, IL 14980 |
| Contact | Jonathan Shlam |
| Correspondent | Jonathan Shlam AGAR GINOSAR ELECTRONICS KIBBUTZ GINOSAR Ginosar, IL 14980 |
| Product Code | GZJ |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-12-10 |
| Decision Date | 1991-06-21 |