The following data is part of a premarket notification filed by Staodynamics, Inc. with the FDA for Tens-aid Sterile Electrodes For Post-op Tens.
| Device ID | K852298 |
| 510k Number | K852298 |
| Device Name: | TENS-AID STERILE ELECTRODES FOR POST-OP TENS |
| Classification | Electrode, Cutaneous |
| Applicant | STAODYNAMICS, INC. 1225 FLORIDA AVE. P.O. BOX 1379 Longmont, CO 80502 |
| Contact | Samuella Emrich |
| Correspondent | Samuella Emrich STAODYNAMICS, INC. 1225 FLORIDA AVE. P.O. BOX 1379 Longmont, CO 80502 |
| Product Code | GXY |
| CFR Regulation Number | 882.1320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-05-29 |
| Decision Date | 1985-06-24 |