Panels › Physical Medicine › Product code IKT · Class 2
Electrode, Needle, Diagnostic Electromyograph
Regulation 890.1385
1510(k)s in 12 months (43 all time)
0recalls in 12 months (2 all time)
2recalls that name a 510(k)
Top companies in IKT
| Company | 510(k)s | Recalls |
|---|---|---|
| Chalgren Enterprises, Inc. | 9 | 1 |
| Technomed Europe | 3 | 1 |
| Dantec Medical, Inc. | 3 | 0 |
| Medicotest A/S | 3 | 0 |
| Natus Manufacturing Limited | 3 | 0 |
| Rhythmlink International, LLC | 3 | 0 |
| Ambu A/S | 2 | 0 |
| Carefusion 209, Inc. | 2 | 0 |
| Medelec, Inc. D.B.A. Teca Corp. | 2 | 0 |
| Medtronic Functional Diagnostics A/S | 2 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 9, 2022 | Technomed Europe Disposable Subdermal Needle Electrode, Pt/lr, 12 x 0.40mm, product number TE/S46/638, 25 needles per package, sterile. Terminated |
IKT | K130136 |
| Sep 21, 2010 | Chalgren Enterprises Inc Disposable Detachable Monopolar Needle Electrode for electromyograph model number 110-725, for Physician use, manufactured by Chalgren Enterprises Inc., Gilroy, CA. Terminated |
IKT | K912283 |
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