TENS AND EMS (TENS AND Muscle Stimulator) JT8012C, JT8016, JT9020E, JT9026
by Shenzhen Jiantuo Electronics Co., Ltd.
510(k) K250360
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK250360 | Date11 May 2025 | 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- Withdrawn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 and EMS (TENS and Muscle Stimulator) JT8012C, JT8016, JT9020E, and JT9026 are transcutaneous electrical nerve stimulators designed to deliver electrical pulses for pain relief and muscle stimulation. These devices fall under the category of nerve stimulators, providing non-invasive therapy by applying electrodes to the skin to modulate nerve signals or facilitate muscle contraction. They are intended for use in managing chronic or acute pain and improving muscle performance through controlled electrical stimulation.
These devices are intended for patient-operated use in home or clinical settings and are classified as Class II medical devices under the FDA’s Special Controls for transcutaneous nerve stimulators. The JT8012C, JT8016, JT9020E, and JT9026 are supplied as reusable electronic units with disposable or reusable electrode pads, depending on the model. They are not sterile and require proper storage to maintain functionality, adhering to manufacturer guidelines for safe operation. The devices received FDA 510(k) clearance under K250360, affirming their substantial equivalence to predicate devices.
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Questions
AI-generated answers, 1 Oct 2026
What are the JT8012C, JT8016, JT9020E, and JT9026 TENS/EMS devices used for?
These devices are designed to deliver transcutaneous electrical nerve stimulation (TENS) and electromyostimulation (EMS) for managing chronic or acute pain and improving muscle performance. They work by applying controlled electrical pulses through electrodes placed on the skin, modulating nerve signals for pain relief or facilitating muscle contractions. They are intended for patient-operated use in both home and clinical settings.
Are the TENS/EMS units reusable, and what about the electrode pads?
The electronic units themselves are reusable. However, the electrode pads vary by model: some models use disposable pads, while others allow for reusable pads. Always follow the manufacturer’s guidelines to ensure proper use and maintain functionality.
Do these devices come sterile, and how should they be stored?
These TENS/EMS devices are not sterile. They require proper storage to maintain functionality and safety. Store them in a clean, dry environment, away from direct sunlight or extreme temperatures, and follow the manufacturer’s specific storage instructions to preserve their performance.
What distinguishes the JT8012C, JT8016, JT9020E, and JT9026 models?
While all four models serve as TENS and EMS stimulators, their differences likely lie in specific features like electrode pad compatibility (disposable vs. reusable), stimulation intensity ranges, or additional functionalities tailored for different clinical or home-use scenarios. Check the manufacturer’s documentation for detailed specifications on each model.
What regulatory clearance do these TENS/EMS devices hold?
These devices received FDA 510(k) clearance under the reference number K250360, confirming their substantial equivalence to predicate devices. They are classified as Class II medical devices under the FDA’s Special Controls for transcutaneous nerve stimulators, ensuring they meet established safety and performance standards.