Home › Device types › IKT
Electrode, Needle, Diagnostic Electromyograph
FDA product code IKT · Class 2 · Physical Medicine
924
Registered devices
150
Adverse events
2
Recalls
43
510(k) clearances
Devices with this code
Bio Protech — BIO PROTECH USA, INC.MediMax Tech — MEDIMAX TECH INC.Technomed Europe — Technomed Engineering B.V.Disposable EMG needle electrodes — SPES MEDICA SPARochester — LifeSync CorporationCadwell — Technomed Engineering B.V.Rochester — LifeSync CorporationBio Protech — BIO PROTECH USA, INC.Technomed Europe — Technomed Engineering B.V.BIONEN — BIONEN SAS DI BARBARA NENCIONI & C.Technomed Europe — Technomed Engineering B.V.Nerveana® — Neurovision Medical Products, Inc.NONE — Neurovision Medical Products, Inc.Ambu — Technomed Engineering B.V.Technomed Europe — Technomed Engineering B.V.Technomed Europe — Technomed Engineering B.V.Rhythmlink® — RHYTHMLINK INTERNATIONAL, LLCDisposable EMG needle electrodes — SPES MEDICA SPATechnomed Europe — Technomed Engineering B.V.Teca TP — NATUS MANUFACTURING LIMITEDChalgren — CHALGREN ENTERPRISESDisposable EMG needle electrodes — SPES MEDICA SPAAmbu — Technomed Engineering B.V.Bio Protech — BIO PROTECH USA, INC.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2022-08-09 | Technomed Europe | Burns of varying degrees can occur to patients with electrodes left in while in the MRI scanner as a result of inadequate safety information in the IFU. |
| 2007-04-12 | Chalgren Enterprises Inc | Sterility Compromised-- Investigation found that individual packaging seals were separating, which may compromise sterility. |
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