The following data is part of a premarket notification filed by A-t Surgical Mfg. Co., Inc. with the FDA for A-t Tens Belt.
| Device ID | K843793 |
| 510k Number | K843793 |
| Device Name: | A-T TENS BELT |
| Classification | Stimulator, Nerve, Transcutaneous, For Pain Relief |
| Applicant | A-T SURGICAL MFG. CO., INC. 359 DWIGHT ST. Holyoke, MA 01040 |
| Contact | Eugene P Kirejczyk |
| Correspondent | Eugene P Kirejczyk A-T SURGICAL MFG. CO., INC. 359 DWIGHT ST. Holyoke, MA 01040 |
| Product Code | GZJ |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-09-14 |
| Decision Date | 1984-10-12 |