Xltek Xcalibur EMG / Lt, Model PK1P33, PK1059
510(k) K052112
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK052112 | Date28 Oct 2005 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- IKN
- FDA applicant
- Excel Tech. , Ltd.
- Device Class
- Class II
- Regulation
- 21 CFR Part 890.1375
- Advisory Committee
- Physical Medicine
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The XLTEK Xcalibur EMG/LT is a diagnostic electromyograph, a device used to measure and record electrical activity produced by skeletal muscles. It evaluates muscle and nerve function by detecting electrical potentials generated during muscle contraction and at rest, aiding in the diagnosis of neuromuscular disorders, peripheral neuropathies, and other conditions affecting muscle and nerve integrity.
This device is supplied as a reusable medical instrument intended for use in clinical settings such as physical medicine and rehabilitation. It operates under sterile conditions when used for invasive procedures and is classified as Class II under FDA regulations with Special Controls. The models PK1P33 and PK1059 are designed for compatibility with standard electromyography applications, with no specific MRI safety classification noted. Storage and handling follow standard medical device protocols to ensure functionality and patient safety.
Other devices from Excel Tech., Ltd.
Questions
AI-generated answers, 1 Oct 2026
What is the XLTEK Xcalibur EMG/LT used for?
The XLTEK Xcalibur EMG/LT (models PK1P33 and PK1059) is a diagnostic electromyograph designed to measure and record electrical activity in skeletal muscles. It evaluates muscle and nerve function by detecting electrical potentials during muscle contraction and at rest, helping diagnose conditions like neuromuscular disorders and peripheral neuropathies. This device is specifically intended for clinical use in physical medicine and rehabilitation settings.
How is the XLTEK Xcalibur EMG/LT supplied and intended for use?
The XLTEK Xcalibur EMG/LT is supplied as a reusable medical instrument, meaning it is designed for repeated use in clinical environments. It is intended for sterile use when performing invasive procedures, ensuring patient safety during diagnostic testing. The device follows standard medical device protocols for storage and handling to maintain functionality and sterility.
Is the XLTEK Xcalibur EMG/LT single-use or reusable?
The XLTEK Xcalibur EMG/LT is explicitly designed as a reusable medical instrument. This classification aligns with its intended use in clinical settings where repeated diagnostic procedures are performed, ensuring cost-effectiveness and compliance with standard medical device maintenance protocols.
What models are included in the XLTEK Xcalibur EMG/LT series?
The XLTEK Xcalibur EMG/LT series includes two specific models: PK1P33 and PK1059. Both models are compatible with standard electromyography applications and are intended for use in diagnosing neuromuscular conditions. These models are part of the same device family but may have slight variations in functionality or features.
What regulatory approval does the XLTEK Xcalibur EMG/LT hold?
The XLTEK Xcalibur EMG/LT (models PK1P33 and PK1059) holds FDA 510(k) clearance, indicating it is classified as a Class II medical device under FDA regulations with Special Controls. This classification reflects its role in diagnostic testing for muscle and nerve function, ensuring it meets stringent performance and safety standards for clinical use.