OTC Electrical Stimulator (MT9001), OTC TENS Device (LT3060)
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K130802 FDA 510(k)
- FDA Product Code
- NUH FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 882.5890 FDA 510(k)
- Regulation Number
- 882.5890 FDA 510(k)
- Advisory Committee
- Neurology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The OTC Electrical Stimulator (MT9001) and OTC TENS Device (LT3060) are transcutaneous electrical nerve stimulators (TENS) and electrical muscle stimulators (EMS), classified as nerve stimulators for over-the-counter use. These devices deliver controlled electrical pulses through surface electrodes to modulate nerve activity, providing temporary pain relief for sore or aching muscles, including regions such as the shoulder.
Intended for home use, these devices are supplied as single-use or reusable units (as specified by the manufacturer) and are regulated under FDA 510(k) clearance (K130802) and the EU Medical Device Regulation (MDR). The MT9001 combines TENS and EMS functionalities, while the LT3060 offers TENS-only operation. Both models adhere to classification NUH for over-the-counter nerve stimulators and are designed for direct patient application without professional supervision.
Frequently asked questions
What is the primary difference between the MT9001 and LT3060 devices in terms of functionality?
The MT9001 combines both transcutaneous electrical nerve stimulation (TENS) and electrical muscle stimulation (EMS) functionalities, allowing it to address both pain relief and muscle activation. In contrast, the LT3060 is designed solely for TENS, providing pain relief through electrical pulses without muscle stimulation features.
Are these devices intended for professional medical use, or are they meant for home use by patients?
These devices are explicitly designed for home use and are classified as over-the-counter (OTC) nerve stimulators. They are intended for direct patient application without requiring professional medical supervision, making them accessible for temporary pain relief in settings like the home.
How are these devices regulated, and what does that mean for their use?
The devices are regulated under the FDA’s 510(k) clearance process (K130802) and comply with the EU Medical Device Regulation (MDR). This means they have undergone evaluation to demonstrate substantial equivalence to a predicate device, ensuring they meet safety and performance standards for their intended use as OTC nerve stimulators. Their classification as NUH (non-prescription nerve stimulators) further confirms they are safe for self-administration.
Can these devices be reused, or are they single-use only?
The manufacturer specifies whether each model (MT9001 or LT3060) is single-use or reusable, though the provided data does not explicitly state reuse instructions. Typically, TENS/EMS devices are designed for repeated use, but users should follow the manufacturer’s guidelines for cleaning, maintenance, and electrode replacement to ensure safety and effectiveness. Always check the included instructions for proper usage.
What types of pain or muscle conditions are these devices intended to address?
These devices are intended for temporary pain relief of sore or aching muscles, particularly in regions like the shoulder. They work by delivering controlled electrical pulses to modulate nerve activity, which can help alleviate discomfort associated with minor muscle strain, overuse, or localized tension. They are not intended for chronic conditions or severe medical issues.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Otc Electrical Stimulator (Mt9001), Otc Tens Device (Lt3060) (K130802 ..., OTC ELECTRICAL STIMULATOR (MT9001), OTC TENS DEVICE… - FDA.report, fda.innolitics.com
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K130802 | Class II | Active |
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Manufacturer
- Manufacturer
- Shenzhen Dongdixin Technology Co., Ltd.
Sources (2)
- FDA 510(k) K130802 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026