The following data is part of a premarket notification filed by Pain Management Technologies with the FDA for Soft-touch Tens Electrode.
| Device ID | K030375 |
| 510k Number | K030375 |
| Device Name: | SOFT-TOUCH TENS ELECTRODE |
| Classification | Electrode, Cutaneous |
| Applicant | PAIN MANAGEMENT TECHNOLOGIES 43 E. MARKET ST. Akron, OH 44308 |
| Contact | Joshua Lefkovitz |
| Correspondent | Joshua Lefkovitz PAIN MANAGEMENT TECHNOLOGIES 43 E. MARKET ST. Akron, OH 44308 |
| Product Code | GXY |
| CFR Regulation Number | 882.1320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-02-04 |
| Decision Date | 2003-05-05 |
| Summary: | summary |