The following data is part of a premarket notification filed by Katecho, Inc. with the FDA for K-stim Clear.
Device ID | K922202 |
510k Number | K922202 |
Device Name: | K-STIM CLEAR |
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 | 1992-05-11 |
Decision Date | 1993-05-17 |