The following data is part of a premarket notification filed by Katecho, Inc. with the FDA for K-sterile Tens Electrodes.
| Device ID | K900997 |
| 510k Number | K900997 |
| Device Name: | K-STERILE TENS ELECTRODES |
| Classification | Electrode, Cutaneous |
| Applicant | KATECHO, INC. 2601 BELL AVE. P.O BOX 21247 Des Moines, IA 50315 |
| Contact | Lorne Scharnberg |
| Correspondent | Lorne Scharnberg KATECHO, INC. 2601 BELL AVE. P.O BOX 21247 Des Moines, IA 50315 |
| Product Code | GXY |
| CFR Regulation Number | 882.1320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-03-02 |
| Decision Date | 1990-03-13 |