The following data is part of a premarket notification filed by Medicon, Inc. with the FDA for Tens Gb1001 Device.
| Device ID | K850855 |
| 510k Number | K850855 |
| Device Name: | TENS GB1001 DEVICE |
| Classification | Stimulator, Nerve, Transcutaneous, For Pain Relief |
| Applicant | MEDICON, INC. 143 NEW CANAAN AVE. Norwalk, CT 06850 |
| Contact | James C Nicholas |
| Correspondent | James C Nicholas MEDICON, INC. 143 NEW CANAAN AVE. Norwalk, CT 06850 |
| Product Code | GZJ |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-03-01 |
| Decision Date | 1986-01-09 |