TENS & EMS Device (LY-ET-01, LY-ET-02, LY-ET-04)
by Jiangxi Royall Smart Technology Co., Ltd.
510(k) K230443
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK230443 | Date22 May 2023 | 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- Withdrawn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
- NUH
- 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 TENS & EMS Device (LY-ET-01, LY-ET-02, LY-ET-04) is a neuromuscular electrical stimulation (NMES) and transcutaneous electrical nerve stimulation (TENS) device. It delivers low-level electrical currents to stimulate nerves and muscles, intended for temporary pain relief in skeletal muscles, including those in the upper and lower limbs. The device operates by modulating nerve signals to alleviate discomfort associated with muscle soreness, strain, or overuse from activities such as exercise or daily tasks. Its design adheres to regulatory standards for neuromodulation devices, ensuring safe and controlled electrical stimulation.
This device is supplied as a reusable, non-sterile medical instrument, intended for use in clinical, home, or fitness settings. It requires no special storage conditions but must be handled according to manufacturer guidelines to maintain functionality and safety. The device has received FDA 510(k) clearance under the Neurology advisory committee, classified under product code NUH, and is intended for temporary pain relief without surgical intervention. No MRI safety classification or sterility requirements are specified in the regulatory submission.
Other devices from Jiangxi Royall Smart Technology Co., Ltd.
Questions
AI-generated answers, 1 Oct 2026
What is the TENS & EMS Device (LY-ET-01, LY-ET-02, LY-ET-04) used for?
This device is designed for temporary pain relief in skeletal muscles, including those in the upper and lower limbs. It uses neuromuscular electrical stimulation (NMES) and transcutaneous electrical nerve stimulation (TENS) to modulate nerve signals, helping alleviate discomfort from muscle soreness, strain, or overuse due to activities like exercise or daily tasks. It is not intended for surgical intervention or chronic conditions requiring ongoing medical treatment.
How is the TENS & EMS Device supplied and stored?
The device is supplied as a reusable, non-sterile medical instrument. It does not require special storage conditions, but it must be handled according to the manufacturer’s guidelines to ensure proper functionality and safety. Regular cleaning and maintenance, as instructed, will help preserve its performance over time.
Is the TENS & EMS Device single-use or reusable?
This device is explicitly designed for reuse. It is not intended for single-use applications, and its durable construction allows for repeated use in clinical, home, or fitness environments. However, adherence to manufacturer guidelines for cleaning and maintenance is essential to ensure safe and effective operation.
What regulatory clearance does the TENS & EMS Device hold?
The TENS & EMS Device (LY-ET-01, LY-ET-02, LY-ET-04) has received FDA 510(k) clearance under the Neurology advisory committee, classified under product code NUH. The clearance indicates it is substantially equivalent to a legally marketed device for temporary pain relief in skeletal muscles, adhering to regulatory standards for neuromodulation.
Are there any special considerations for using this device in clinical settings?
While the device is suitable for clinical use, it is not sterile and should not be used in procedures requiring sterile conditions. Clinicians should follow the manufacturer’s instructions for proper setup, electrode placement, and patient monitoring to ensure safe and effective use. Additionally, the device is not MRI-safe, so patients should avoid MRI environments while using it.