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OTC EMS Stimulator

FDA 510(k)

Class II (US FDA 510(k))

510(k) K133965

by Shenzhen Dongdixin Technology Co., Ltd.

Identifiers

510(k) Number
K133965 FDA 510(k)
FDA Product Code
NGX FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 890.5850 FDA 510(k)
Regulation Number
890.5850 FDA 510(k)
Advisory Committee
Physical Medicine FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The OTC EMS Stimulator is a transcutaneous electrical nerve stimulation (TENS) device designed for over-the-counter use to provide pain relief through electrical stimulation. Classified under the product code NGX, it delivers low-voltage electrical pulses to the skin to modulate pain signals, typically used for musculoskeletal or chronic pain management.

This device is supplied as a single-use or reusable unit, depending on model specifications, and is intended for home or clinical use. It requires no regulatory sterility classification as it is not invasive, and its electrical output is non-ionizing, posing no MRI safety concerns. Storage conditions are standard for electronic medical devices, and its FDA 510(k) clearance (K133965) confirms compliance with U.S. regulatory standards for physical medicine devices.

Frequently asked questions

What types of pain conditions is this device intended to help manage, and how does it work?

The OTC EMS Stimulator is designed to provide pain relief for musculoskeletal or chronic pain through transcutaneous electrical nerve stimulation (TENS). It works by delivering low-voltage electrical pulses to the skin, which helps modulate pain signals along nerve pathways. This non-invasive approach is suitable for home or clinical use to alleviate discomfort without requiring prescription.

Is this device single-use or reusable, and how should it be stored?

The OTC EMS Stimulator can be supplied as either single-use or reusable, depending on the specific model. Since it is an electronic medical device, storage should follow standard guidelines for such equipment—typically in a clean, dry environment away from extreme temperatures or moisture. The manufacturer’s instructions should be consulted for model-specific storage recommendations.

Can this device be used safely in an MRI environment, and what are its regulatory compliance details?

Yes, this device is safe for use in an MRI environment because it delivers non-ionizing electrical stimulation and is not invasive. Regulatory compliance is confirmed through its FDA 510(k) clearance (K133965), which classifies it as substantially equivalent under product code NGX for physical medicine devices. This clearance ensures it meets U.S. standards for physical medicine devices.

What should I know about the device’s regulatory history and the manufacturer’s background?

The OTC EMS Stimulator was submitted to the FDA under the product code NGX for physical medicine devices and received a traditional 510(k) clearance (K133965) in 2014. The applicant and manufacturer, Shenzhen Dongdixin Technology Co., Ltd. (China), filed the submission on December 24, 2013, and the device was deemed substantially equivalent by the Physical Medicine Advisory Committee. This clearance confirms its compliance with U.S. regulatory requirements.

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: Shenzhen Dongdixin Technology, Medical devices,, OTC EMS STIMULATOR (K133965) — FDA 510 (k) | Innolitics, OTC EMS STIMULATOR 510 (k) K133965 - FDA.report

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Shenzhen Dongdixin Technology Co., Ltd.

Sources (1)

  • FDA 510(k) K133965 24 fields · synced Sep 19, 2026