Excel Tech. , Ltd.
Medical device manufacturer in Oakville, CA.
58510(k) clearances
0PMA approvals
0recalls
Device types
- GWQ Full-Montage Standard Electroencephalograph 15
- GEX Powered Laser Surgical Instrument 7
- IPF Stimulator, Muscle, Powered 6
- GWF Stimulator, Electrical, Evoked Response 6
- LIH Interferential Current Therapy 5
- IMG Stimulator, Ultrasound And Muscle, For Use… 3
- OMB Automatic Event Detection Software For… 3
- IKN Electromyograph, Diagnostic 2
- OLV Standard Polysomnograph With… 2
- GWE Stimulator, Photic, Evoked Response 2
- GWJ Stimulator, Auditory, Evoked Response 1
- ITH Equipment, Traction, Powered 1
- IMI Ultrasonic Diathermy For Use In Applying… 1
- GXZ Electrode, Needle 1
- JXE Device, Nerve Conduction Velocity Measurement 1
- GXY Electrode, Cutaneous 1
- ETN Stimulator, Nerve 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K062549 | Xltek Stimulator Probes, Models 105233, 105234, 105235, 105236, 105237 and 105238ETN · Traditional | 10/04/2006SE |
| K061269 | Xltek Clean Signal Adhesive ElectrodesGXY · Traditional | 08/14/2006SE |
| K053386 | Xltek EMU40 EEG Headbox, Model PK1072GWQ · Traditional | 04/21/2006SE |
| K053058 | Xltek Neuropath, Model PK1070JXE · Traditional | 02/07/2006SE |
| K052112 | Xltek Xcalibur Emg / LT, Model PK1P33, PK1059IKN · Special | 10/28/2005SE |
| K052111 | Xltek Clear Signal Sub-Dermal Needle, Models 102889, 102798, 102799, 102382GXZ · Abbreviated | 08/17/2005SE |
| K042223 | Xltek Connex Ip Headbox, Model 1054OMB · Special | 09/16/2004SE |
| K042150 | Xltek Trex MODEL#10309GWQ · Special | 08/27/2004SE |
| K040358 | Xltek Protektor Stimulator, Models 10247 & 10248GWF · Traditional | 08/06/2004SE |
| K040360 | EMU128S, Model EX-NW-128SGWQ · Special | 03/12/2004SE |
| K022037 | Xltek Sleep SystemOLV · Special | 09/10/2002SE |
| K021599 | 96 Channel EEG Headbox Model EMU96GWQ · Traditional | 08/13/2002SE |
| K011794 | Xltek LED Goggles, Model LED-01GWE · Traditional | 10/01/2001SE |
| K010086 | Real Patient Excel Neurowork, Model Ex-Rp-Eeg (Proposed)GWQ · Traditional | 04/09/2001SE |
| K010092 | Xltek Evoked Potential Headbox, Model Real Patient EP-8-RP (Proposed)GWF · Traditional | 04/02/2001SE |
| K010090 | Xltek Evoked Potential Headbox, Model EP-4-RP (Proposed)GWF · Traditional | 03/26/2001SE |
| K010089 | Real Patient Wireless Ambulatory EEG, Model Ex-Amb-Wireless-Rp (Proposed)GWQ · Traditional | 03/26/2001SE |
| K010088 | Real Patient Ambulatory EEG, Model Ex-Amb-Rp (Proposed)GWQ · Traditional | 03/26/2001SE |
| K010087 | Xltek Real Patient Evoked Potential Headbox, Model EP-16-RPGWF · Traditional | 03/19/2001SE |
| K010084 | Real Patient Real Patient 128 Channel EEG Headbox, Model EX-NW-128-RPGWQ · Traditional | 03/16/2001SE |
| K010085 | EEG Real Patient Spike and Event Detector Module, Model Ex-Sp-Rp (Proposed)OMB · Traditional | 03/15/2001SE |
| K010150 | 64 Channel EEG / Model Number EX-NW-64GWQ · Special | 02/09/2001SE |
| K010091 | EEG with Video, Model Ex-NwGWQ · Special | 02/01/2001SE |
| K002332 | EEG Spike and Event Detector ModuleOMB · Traditional | 10/06/2000SE |
| K000919 | 128 Channel EEG Headbox, Model EX-NW-128GWQ · Traditional | 08/31/2000SE |
| K001166 | Ultra V Therapeutic UltrasoundIMG · Traditional | 07/07/2000SE |
| K001103 | Wireless Ambulatory EEG, Model Ex-Amb-Wireless (Proposed)GWQ · Traditional | 06/30/2000SE |
| K001101 | Xltek Evoked Potential Headbox, Model EP-4GWF · Traditional | 06/30/2000SE |
| K000898 | EEG with Video, Model Ex-NwGWQ · Special | 04/14/2000SE |
| K992313 | XL Tek Evoked Potential Headbox, Model EP-16GWF · Traditional | 08/19/1999SE |
| K991903 | Excel Photic Stimulator, Model (XLPS-1)GWE · Traditional | 08/04/1999SE |
| K991900 | Xltek Polysomnography Headbox, Model # PSG-40OLV · Traditional | 07/12/1999SE |
| K982479 | Excel Ambulatory EEGGWQ · Traditional | 10/14/1998SE |
| K980214 | Excel Neuro WorksGWQ · Traditional | 04/21/1998SE |
| K972157 | Excel Av Stim 1000GWJ · Traditional | 01/30/1998SE |
| K960489 | Ultra IVIPF · Traditional | 03/27/1996SN |
| K960096 | Ultra IIIIPF · Traditional | 03/27/1996SN |
| K955860 | Multi III, IVLIH · Traditional | 03/22/1996SN |
| K955387 | Isotron III, Isotron IVLIH · Traditional | 03/22/1996SN |
| K941144 | Excel EmgIKN · Traditional | 11/07/1995SE |
| K941815 | Isotron IIILIH · Traditional | 05/03/1995SN |
| K940200 | Excel TXITH · Traditional | 06/07/1994SE |
| K932730 | Excel's EST-30 Ho:Yag Laser SystemGEX · Traditional | 03/01/1994SE |
| K931051 | Model 110 Nd:Yag LaserGEX · Traditional | 06/25/1993SE |
| K923076 | Ultra SXIMI · Traditional | 03/09/1993SE |
| K921952 | Ultra IIIIMG · Traditional | 03/09/1993SE |
| K924729 | Excel Tripulse MODEL3000GEX · Traditional | 01/15/1993SE |
| K921954 | Isotron IIILIH · Traditional | 08/26/1992SE |
| K921953 | Multi IIILIH · Traditional | 08/26/1992SE |
| K922375 | Excel Duopulse Model 3000 Combination Ho/Er:YagGEX · Traditional | 07/08/1992SE |
| K915679 | Excel Duopaulse Model 2000GEX · Traditional | 06/24/1992SE |
| K915169 | Excel Model Xlt-Two Holmium:Yag Laser SystemGEX · Traditional | 04/02/1992SE |
| K914849 | Excel Model Xlt-One Nd:Yag Laser SystemGEX · Traditional | 02/25/1992SE |
| K900823 | Isotron 220IPF · Traditional | 03/26/1990SE |
| K896836 | Excel StimIPF · Traditional | 02/20/1990SE |
| K895983 | Multistim PlusIPF · Traditional | 02/20/1990SE |
| K895690 | Ultra (Therapeutic Ultrasound Device)IMG · Traditional | 02/20/1990SE |
| K844617 | Excel Tech MST-7 Isoelectronic Therapy DeviceIPF · Traditional | 03/05/1985SE |