Bio Protech, Inc.
Medical device manufacturer in Wonju-Si, KR.
17510(k) clearances
0PMA approvals
0recalls
Device types
- DRX Electrode, Electrocardiograph 4
- GXY Electrode, Cutaneous 4
- GEI Electrosurgical, Cutting & Coagulation &… 4
- GZJ Stimulator, Nerve, Transcutaneous, For Pain… 1
- IPF Stimulator, Muscle, Powered 1
- LIH Interferential Current Therapy 1
- IKT Electrode, Needle, Diagnostic Electromyograph 1
- FYD Apparatus, Exhaust, Surgical 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K192035 | EvaQMax Smoke Evacuation SystemFYD · Traditional | 08/29/2019SE |
| K152984 | Disposable Concentric Needle electrodes, Disposable Monopolar Needle electrodes…IKT · Traditional | 06/03/2016SE |
| K153019 | Disposable Adhesive Surface Electrodes, Disposable/Reusable Cup ElectrodesGXY · Traditional | 03/21/2016SE |
| K143103 | PROPENCIL Smoke PencilGEI · Traditional | 07/16/2015SE |
| K142099 | Cutaneous ElectrodesGXY · Traditional | 11/17/2014SE |
| K111270 | Reusable Stimulating ElectrodesGXY · Traditional | 09/13/2011SE |
| K100246 | MAX-IF1000LIH · Traditional | 11/24/2010SE |
| K091248 | Maxems, Models 1000 and 2000IPF · Traditional | 11/30/2009SE |
| K092732 | Propencil Esu PencilGEI · Traditional | 11/25/2009SE |
| K092761 | Proplate, Models 9641C, 9641F, P9641C, P9641F, 9642C, 9642F and P9642CGEI · Special | 11/24/2009SE |
| K083148 | Telectrode Wet Gel ECG ElectrodeDRX · Traditional | 11/07/2008SE |
| K073438 | Prostim 1000/2000GZJ · Traditional | 02/07/2008SE |
| K073360 | ProplateGEI · Traditional | 12/19/2007SE |
| K053011 | Pro-Neo Neonatal ECG Electrode, Models SG15 and SR20DRX · Traditional | 12/14/2005SE |
| K042301 | Protens ElectrodeGXY · Traditional | 09/03/2004SE |
| K040784 | Protab ECG Tabb ElectrodeDRX · Traditional | 04/07/2004SE |
| K020003 | Electrocardiograph (ECG) Electrode, Non-SterileDRX · Traditional | 11/07/2002SE |