Electronic Pain Relievers (K883811)
510(k) K883811
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK883811 | Date24 Oct 1989 | 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- Withdrawn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
- Full name
- Electronic Pain Relievers
- 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 Electronic Pain Relievers (K883811) is a Stimulator, Nerve, Transcutaneous, For Pain Relief, classified under FDA product code GZJ. This device delivers transcutaneous electrical nerve stimulation (TENS) to alleviate pain by modulating nerve signals, primarily indicated for neuromuscular pain management. It operates through low-voltage electrical impulses applied via surface electrodes, targeting specific areas to provide temporary relief. The device is designed for outpatient and home use, adhering to FDA-substantiated equivalence standards for neuromodulation therapies.
This device is supplied as a reusable medical instrument, intended for clinical and home-based applications under professional supervision or patient self-administration. It requires no sterilization for single-patient use but must be cleaned and maintained per manufacturer guidelines to ensure electrode integrity and electrical safety. The device is not MRI-compatible and is regulated under FDA 510(k) clearance (K883811), with a classification review by the Neurology Advisory Committee. Storage should follow the manufacturer’s instructions to preserve functionality, and usage must comply with the original 1989 clearance parameters for transcutaneous nerve stimulation.
Questions
AI-generated answers, 1 Oct 2026
What is the Electronic Pain Relievers (K883811) used for?
The Electronic Pain Relievers (K883811) is a transcutaneous electrical nerve stimulation (TENS) device designed to alleviate neuromuscular pain. It works by delivering low-voltage electrical impulses through surface electrodes to modulate nerve signals, providing temporary relief for conditions managed under neuromodulation therapies. This device is specifically cleared for outpatient and home use, adhering to FDA standards for pain management via electrical stimulation.
Is the Electronic Pain Relievers (K883811) single-use or reusable?
The Electronic Pain Relievers (K883811) is a reusable medical instrument. It is intended for repeated use in both clinical and home settings, provided it is cleaned and maintained according to the manufacturer’s guidelines. Unlike single-use devices, this model does not require sterilization for individual patient use, but proper care ensures electrode integrity and electrical safety for ongoing applications.
How should the Electronic Pain Relievers (K883811) be stored?
Storage of the Electronic Pain Relievers (K883811) must follow the manufacturer’s instructions to preserve its functionality. While the device is reusable and not subject to sterilization for single-patient use, proper storage conditions—such as avoiding moisture, extreme temperatures, or physical damage—are critical to maintaining its performance and safety. Adhering to these guidelines ensures the device remains operational for its intended neuromodulation applications.
Can the Electronic Pain Relievers (K883811) be used in an MRI environment?
No, the Electronic Pain Relievers (K883811) is not MRI-compatible. Magnetic resonance imaging (MRI) environments generate strong magnetic fields that can interfere with electronic devices, potentially causing malfunctions or safety hazards. Always confirm compatibility with the device’s specifications before use in or near an MRI scanner.
What regulatory pathway does the Electronic Pain Relievers (K883811) follow?
The Electronic Pain Relievers (K883811) is regulated under the FDA’s 510(k) clearance pathway, specifically classified under product code GZJ for nerve stimulators. It received a decision of Substantially Equivalent (SESE) in 1989 after review by the Neurology Advisory Committee (NE). This clearance ensures the device meets FDA standards for transcutaneous nerve stimulation as originally intended for neuromuscular pain relief.