The following data is part of a premarket notification filed by Katecho, Inc. with the FDA for Low Back Strip (or) K-back.
| Device ID | K912381 |
| 510k Number | K912381 |
| Device Name: | LOW BACK STRIP (OR) K-BACK |
| Classification | Stimulator, Nerve, Transcutaneous, For Pain Relief |
| 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 | GZJ |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-05-29 |
| Decision Date | 1992-01-30 |