IKTClass II
Electrode, Needle, Diagnostic Electromyograph
21 CFR 890.1385 / Physical Medicine
IKT is the FDA product code for Electrode, Needle, Diagnostic Electromyograph, a class II device type, regulated under 21 CFR 890.1385. As of , FDA records hold 43 510(k) clearances under this code, the most recent dated , and 2 recalls.
Classification record
- Product code
- IKT
- Device name
- Electrode, Needle, Diagnostic Electromyograph
- Regulation
- 21 CFR 890.1385
- Device class
- Class II
- Review panel
- Physical Medicine
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- Yes
- Ingested clearances
- 43
- Ingested recalls
- 2
Clearances, product code IKT
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1986 | 1 |
| 1987 | 1 |
| 1990 | 2 |
| 1992 | 2 |
| 1993 | 1 |
| 1994 | 3 |
| 1995 | 3 |
| 1996 | 3 |
| 1997 | 3 |
| 1998 | 1 |
| 1999 | 3 |
| 2000 | 1 |
| 2001 | 2 |
| 2002 | 1 |
| 2007 | 2 |
| 2008 | 1 |
| 2009 | 3 |
| 2010 | 2 |
| 2011 | 2 |
| 2012 | 1 |
| 2015 | 1 |
| 2016 | 1 |
| 2017 | 1 |
| 2018 | 1 |
| 2026 | 1 |
Applicants with the most clearances
Product code IKT| Applicant | Clearances |
|---|---|
| Chalgren Enterprises, Inc. | 9 |
| Dantec Medical, Inc. | 3 |
| Medicotest, Inc. | 3 |
| Natus Manufacturing Limited | 3 |
| Rhythmlink International, LLC | 3 |
| Technomed Europe | 3 |
| Ambu A/S | 2 |
| Medtronic, Inc. | 2 |
| Medelec, Inc. D.B.A. Teca Corp. | 2 |
| Medtronic Functional Diagnostics A/S | 2 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.