Endura Reusable TENS and NMES Electrodes
by Selectivemed Components, Inc.
510(k) K946230
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK946230 | Date22 Dec 1995 | 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- Withdrawn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
- GZJ
- Device Class
- Class II
- Regulation
- 21 CFR Part 882.5890
- Advisory Committee
- Neurology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Endura Reusable TENS and NMES Electrodes are reusable electrodes designed for transcutaneous electrical nerve stimulation (TENS) and neuromuscular electrical stimulation (NMES). These electrodes deliver low-voltage electrical currents to modulate pain or facilitate muscle stimulation, respectively, as part of physical therapy or pain management protocols. They are intended for repeated use across multiple patients, provided they are properly cleaned and maintained between applications. The electrodes are classified under product code GZJ, reflecting their role in neuromuscular and pain management applications.
These electrodes are supplied as reusable medical devices, requiring cleaning and disinfection between uses to ensure sterility and patient safety. They are intended for use in clinical settings such as physical therapy clinics, rehabilitation centers, or home healthcare environments. The device carries an FDA 510(k) clearance (K946230) under the Traditional 510(k) review pathway, with a decision date of December 22, 1995. No specific MRI safety information is provided, and their size or additional technical specifications are not detailed in the available data.
Other devices from Selectivemed Components, Inc.
Questions
AI-generated answers, 1 Oct 2026
What are the Endura reusable TENS/NMES electrodes used for?
These electrodes deliver low-voltage electrical currents for two primary clinical applications: transcutaneous electrical nerve stimulation (TENS) to manage pain and neuromuscular electrical stimulation (NMES) to facilitate muscle activation. They are designed as part of physical therapy or pain management protocols in settings like rehabilitation centers, physical therapy clinics, or home healthcare environments.
How are the Endura reusable electrodes supplied and prepared for use?
The electrodes are supplied as reusable medical devices, meaning they are intended for multiple patient uses with proper cleaning and disinfection between applications. This ensures sterility and patient safety, distinguishing them from single-use alternatives. Follow manufacturer guidelines for cleaning protocols to maintain functionality and compliance with clinical standards.
Are these electrodes sterile when first received?
No, the electrodes are not sterile upon receipt due to their reusable design. Sterility is achieved through cleaning and disinfection procedures performed between uses. This process is critical to prevent cross-contamination and ensure safe, repeated use across patients.
Can these electrodes be reused across different patients?
Yes, these electrodes are explicitly designed for reuse across multiple patients, provided they are thoroughly cleaned and disinfected between each use. This design reduces waste and cost while maintaining safety when proper maintenance protocols are followed.
What regulatory clearance do the Endura reusable TENS/NMES electrodes hold?
The electrodes carry an FDA 510(k) clearance (K946230) under the Traditional 510(k) review pathway, with a decision date of December 22, 1995. This clearance confirms their substantial equivalence to a predicate device and compliance with U.S. regulatory standards for neuromuscular and pain management applications.