Everyway OTC EMS Model EV-805
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K162744 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 Everyway OTC EMS Model EV-805 is a transcutaneous electrical nerve stimulation (TENS) device, designed to deliver low-voltage electrical currents to the skin for pain relief. It operates by modulating nerve signals to reduce perceived pain through non-invasive electrical stimulation, commonly used for musculoskeletal or chronic pain management.
This device is supplied as a reusable, non-sterile medical instrument intended for home or clinical use. It is cleared under the FDA’s 510(k) pathway as substantially equivalent to predicate devices, with regulatory compliance also meeting EU MDR standards. The device requires proper storage in a clean, dry environment and is intended for single-user operation, adhering to manufacturer guidelines for safe and effective application.
Frequently asked questions
What types of pain conditions is the Everyway OTC EMS Model EV-805 intended to help manage, and how does it work?
The Everyway OTC EMS Model EV-805 is designed for pain relief by delivering low-voltage electrical currents through the skin, a method known as transcutaneous electrical nerve stimulation (TENS). It works by modulating nerve signals to reduce perceived pain, which is commonly used for managing musculoskeletal pain or chronic pain. The device is not intended for acute pain or conditions requiring invasive procedures, but rather for non-invasive, over-the-counter pain management in home or clinical settings.
Is the Everyway OTC EMS Model EV-805 meant for single-use or repeated use by the same patient, and how should it be stored?
The Everyway OTC EMS Model EV-805 is a reusable device, intended for single-user operation only. To maintain its functionality and safety, it should be stored in a clean, dry environment, following the manufacturer’s guidelines. Proper storage ensures the device remains effective for repeated use while minimizing the risk of contamination or damage.
What regulatory pathways has the Everyway OTC EMS Model EV-805 followed, and what does that mean for its use?
The Everyway OTC EMS Model EV-805 has been cleared under the FDA’s 510(k) pathway as substantially equivalent to predicate devices, specifically through the Physical Medicine advisory committee. It also complies with EU MDR standards, indicating it meets regulatory requirements for safety and performance in both the U.S. and European markets. This clearance does not imply any specific clinical indication but confirms the device’s adherence to established safety and efficacy standards.
How is the Everyway OTC EMS Model EV-805 supplied, and is it sterile?
The Everyway OTC EMS Model EV-805 is supplied as a reusable, non-sterile medical instrument. Since it is intended for transcutaneous (skin-surface) application, sterility is not required, but it must be kept clean and dry when not in use. The device’s reusable nature allows for repeated use by the same patient, provided proper care and maintenance are followed.
What should a clinician or patient consider before using the Everyway OTC EMS Model EV-805, especially regarding its intended use and limitations?
Before using the Everyway OTC EMS Model EV-805, clinicians or patients should confirm it is intended for non-invasive pain relief via electrical stimulation, particularly for musculoskeletal or chronic pain. It is not a substitute for medical treatment of acute conditions or severe pain. The device is cleared for single-user, reusable operation in home or clinical settings, so proper training on application and safety guidelines is recommended to avoid misuse or adverse effects.
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.
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 | K162744 | Class II | Active |
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Manufacturer
- Manufacturer
- Everyway Medical Instrument Co., Ltd.
Sources (2)
- FDA 510(k) K162744 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 28, 2026