The following data is part of a premarket notification filed by Katecho, Inc. with the FDA for Km-10 Tens Electrode.
| Device ID | K000870 |
| 510k Number | K000870 |
| Device Name: | KM-10 TENS ELECTRODE |
| Classification | Electrode, Cutaneous |
| Applicant | KATECHO, INC. 2500 BELL AVE. P.O. BOX 21247 Des Moines, IA 50321 |
| Contact | Warren R Walters |
| Correspondent | Warren R Walters KATECHO, INC. 2500 BELL AVE. P.O. BOX 21247 Des Moines, IA 50321 |
| Product Code | GXY |
| CFR Regulation Number | 882.1320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-03-20 |
| Decision Date | 2000-11-07 |