Compex Wireless USA
FDA 510(k)Class II (US FDA 510(k))
by Djo, Llc
Identifiers
- 510(k) Number
- K170903 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 Compex Wireless USA is a Neuromuscular Electrical Stimulation (NMES) device (Product Code: NGX) designed for electrical muscle stimulation. It delivers wireless, low-intensity electrical impulses to healthy muscles, aiding in performance enhancement and recovery. The device is classified under the Physical Medicine category and is intended for over-the-counter use by adults.
This device is supplied as a reusable, non-sterile system intended for home or fitness settings. It operates wirelessly, eliminating the need for cables, and is approved under FDA 510(k) clearance (K170903) as substantially equivalent to existing devices. No specific MRI safety classification is stated, and storage conditions are not detailed in the regulatory data. The device is manufactured by DJO, LLC, with no third-party involvement in its clearance process.
Frequently asked questions
What is the Compex Wireless USA used for?
The Compex Wireless USA is a Neuromuscular Electrical Stimulation (NMES) device designed to deliver low-intensity electrical impulses to healthy muscles. It is intended for performance enhancement and muscle recovery in adults, making it suitable for use in home or fitness settings. The device stimulates muscles wirelessly, eliminating the need for cables, and is classified under Physical Medicine.
Is the Compex Wireless USA reusable or single-use?
The Compex Wireless USA is supplied as a reusable system. It is not intended for sterile use, meaning it is designed for repeated use in non-clinical environments like home or fitness settings. Reusability is common for devices like this, as they are not exposed to sterile conditions and are meant for general wellness applications.
How is the Compex Wireless USA supplied?
The device is supplied as a complete, reusable system for home or fitness use. It does not require sterile packaging, as it is not intended for clinical or surgical environments. The wireless design means no cables are included, simplifying setup and portability.
Are there different sizes or models of the Compex Wireless USA?
The provided data does not specify multiple sizes or models for the Compex Wireless USA. It is described as a single device type under the product code NGX, intended for general neuromuscular stimulation. If variations exist, they would likely be noted in the device’s user manual or additional manufacturer documentation.
What storage conditions should be followed for the Compex Wireless USA?
The regulatory data for the Compex Wireless USA does not detail specific storage conditions. However, as a reusable, non-sterile device, it should be stored in a clean, dry environment away from direct sunlight, moisture, or extreme temperatures. Always refer to the manufacturer’s instructions for best practices.
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: Compex Wireless USA User Manual | AI Chat & PDF Download | Manualzz, DJO Global Launches Compex® Wireless USA™ - compexusa.com, Compex Wireless USA by DJO, LLC | FDA 510 (k) Summary
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K170903 | Class II | Active |
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Manufacturer
- Manufacturer
- Djo, Llc
Sources (1)
- FDA 510(k) K170903 24 fields · synced Oct 1, 2026