Easy TENS
510(k) K881704
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK881704 | Date4 May 1988 | 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- Withdrawn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 Easy TENS is a transcutaneous electrical nerve stimulation (TENS) device, classified under the product code GZJ. It delivers low-voltage electrical pulses to the skin to modulate pain signals, providing non-invasive pain relief for various musculoskeletal and neurological conditions. Designed for patient self-administration, it operates via adhesive electrodes applied to the skin, targeting specific nerve pathways to alleviate discomfort without pharmacological intervention.
Supplied as a reusable device, the Easy TENS is intended for home or clinical use under professional guidance. It requires no sterilisation and is regulated under FDA 510(k) clearance (K881704) with a traditional review pathway, classified under the Neurology advisory committee. The device is not MRI-compatible and must be stored in a clean, dry environment to preserve functionality. No additional regulatory markings beyond the FDA clearance are stated in the specifications.
Other devices from American Imex
Questions
AI-generated answers, 1 Oct 2026
What is the Easy TENS used for?
The Easy TENS is a transcutaneous electrical nerve stimulation (TENS) device designed to provide non-invasive pain relief for musculoskeletal and neurological conditions. It works by delivering low-voltage electrical pulses through adhesive electrodes applied to the skin, which help modulate pain signals along specific nerve pathways. This approach avoids pharmacological intervention, making it suitable for patients seeking alternative pain management options.
Is the Easy TENS reusable or single-use?
The Easy TENS is a reusable device, intended for repeated use by patients at home or in clinical settings under professional guidance. Unlike single-use devices, it is built to withstand multiple applications, provided it is stored and handled properly to maintain its functionality and hygiene.
How should the Easy TENS be stored?
The Easy TENS must be stored in a clean, dry environment to ensure its proper functioning and longevity. Avoid exposure to moisture, extreme temperatures, or direct sunlight, as these conditions can damage the device. Regular cleaning of the device with a dry cloth is recommended to maintain its performance.
Is the Easy TENS compatible with MRI machines?
No, the Easy TENS is explicitly stated as not MRI-compatible. If used in a facility with MRI equipment, it should be kept away from the scanning area to prevent interference or damage to either the device or the MRI system.
What regulatory pathway does the Easy TENS follow?
The Easy TENS is regulated under the FDA 510(k) clearance process, specifically with clearance number K881704. It was classified under the Neurology advisory committee and received a decision of Substantially Equivalent (SESE) through a traditional review pathway. This means it was determined to be as safe and effective as a legally marketed device that served as its predicate.