Xltek Xcalibur Emg / LT, Model PK1P33, PK1059
FDA 510(k) K052112 · Excel Tech. , Ltd.
510(k) numberK052112
Submission
- Device name
- Xltek Xcalibur Emg / LT, Model PK1P33, PK1059
- Applicant
- Excel Tech. , Ltd.
Oakville, CA - Received
- August 4, 2005
- Decision date
- October 28, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- IKN – Electromyograph, Diagnostic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 890.1375
- Specialty
- Physical Medicine
Other 510(k)s with product code IKN
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K172743 | Natus VikingQuestIKN · Special | Natus Neurology Incorporated | 12/19/2017SE |
| K163150 | ViMove2IKN · Special | Dorsavi, Ltd. | 07/14/2017SE |
| K162383 | Cadwell Sierra Summit, Cadwell Sierra AscentIKN · Traditional | Cadwell Industries, Inc. | 03/01/2017SE |
| K142494 | ViMoveIKN · Traditional | Dorsavi, Ltd. | 05/28/2015SE |
| K131094 | VimoveIKN · Traditional | Dorsa VI Pty., Ltd. | 07/11/2014SE |
| K123902 | Physical Monitoring Registration Unit-S (Pmru-S)IKN · Traditional | Oktx, LLC | 09/13/2013SE |
| K123399 | Myovision 3.0 Wirefree SystemIKN · Traditional | Precision Biometrics, Inc. | 08/01/2013SE |
| K113074 | Cmap ProIKN · Traditional | Medical Technologies, Inc. | 02/02/2012SE |
| K102610 | Focus Emg DeviceIKN · Traditional | Teleemg, LLC USA | 03/04/2011SE |
| K110048 | Cersr Electromyography SystemIKN · Special | Spinematrix, Inc. | 01/26/2011SE |
More from Spinematrix, Inc.
| 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 |
| 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 |
Questions and answers
When was Xltek Xcalibur Emg / LT, Model PK1P33, PK1059 cleared by the FDA?
Xltek Xcalibur Emg / LT, Model PK1P33, PK1059 (K052112) received a 510(k) decision of Substantially Equivalent on October 28, 2005, 85 days after the submission was received.
What is the product code of K052112?
The FDA product code is IKN – Electromyograph, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 890.1375.