Identifiers
- 510(k) Number
- K172809 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 Combo TENS/EMS System is a dual-modality electrical stimulator designed for over-the-counter use. It combines Transcutaneous Electrical Nerve Stimulation (TENS) for pain relief and Electrical Muscle Stimulation (EMS) for muscle activation. This device delivers controlled electrical pulses through adhesive electrodes applied to the skin, targeting nerve pathways or muscle fibers as specified by the user. Its classification under product code NUH aligns with neuromuscular stimulation devices intended for non-prescription applications.
The system is supplied as a reusable device, intended for home or clinical use by trained individuals. It operates without requiring sterile conditions, though electrodes should be cleaned between uses. The device is not MRI-safe and must be removed prior to MRI procedures. Authorized for marketing via FDA 510(k) clearance (K172809) under the Special 510(k) pathway, it adheres to regulatory standards for neuromuscular stimulation devices. Storage instructions and additional safety warnings are detailed in the manufacturer’s provided documentation.
Frequently asked questions
What is the OTC Combo TENS/EMS System used for?
The OTC Combo TENS/EMS System is designed for over-the-counter use to provide two distinct therapeutic functions: Transcutaneous Electrical Nerve Stimulation (TENS) for pain relief and Electrical Muscle Stimulation (EMS) for muscle activation. TENS works by delivering controlled electrical pulses to target nerve pathways, helping to alleviate pain, while EMS stimulates muscle fibers to promote activation and recovery. This dual-modality approach allows users to address both pain management and muscle engagement in a single device.
How is the OTC Combo TENS/EMS System supplied and intended for use?
The OTC Combo TENS/EMS System is supplied as a reusable device, meaning it is not single-use and can be used repeatedly for both home and clinical applications by trained individuals. It is not intended for sterile environments, though electrodes should be cleaned between uses to maintain hygiene. The device is designed for easy application in non-clinical settings, such as at home, where users can apply adhesive electrodes to the skin for targeted stimulation.
Is the OTC Combo TENS/EMS System sterile, and what are the safety considerations?
The OTC Combo TENS/EMS System is not sterile and is not intended for use in sterile conditions. While the device itself does not require sterilization, proper hygiene practices are recommended, particularly for the adhesive electrodes, which should be cleaned between uses to prevent contamination. Additionally, the device is not MRI-safe, so it must be removed before undergoing MRI procedures to avoid interference or safety risks.
Can the OTC Combo TENS/EMS System be reused, and how should it be stored?
Yes, the OTC Combo TENS/EMS System is designed for reuse, making it a cost-effective option for both home and clinical settings. To ensure longevity and safe operation, it should be stored according to the manufacturer’s guidelines, which are detailed in the provided documentation. Proper storage typically involves keeping the device in a dry, clean environment away from direct sunlight or extreme temperatures. The electrodes should also be stored carefully to maintain their adhesive properties.
What regulatory approval does the OTC Combo TENS/EMS System hold, and how was it classified?
The OTC Combo TENS/EMS System has been authorized for marketing via FDA 510(k) clearance under the Special 510(k) pathway, specifically clearance number K172809. It falls under product code NUH, which categorizes it as a neuromuscular stimulation device intended for non-prescription applications. The device was determined to be substantially equivalent to a predicate device, as reviewed by the Neurology Advisory Committee, ensuring it meets regulatory standards for safety and effectiveness.
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 Combo TENS/EMS System (K172809) — FDA 510(k) | Innolitics, Home | Well-Life, OTC COMBO TENS/EMS SYSTEM (K141299) — FDA 510(k) | Innolitics, OTC Combo TENS/EMS System — FDA 510 (k) K172809 | MedTracker, OTC Combo TENS/EMS System (K172809) — FDA 510(k) | Innolitics
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K172809 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Well-Life Healthcare Limited
Sources (1)
- FDA 510(k) K172809 24 fields · synced Oct 6, 2026