Identifiers
- 510(k) Number
- K100441 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 Xiniwave Model XW-18 is a transcutaneous nerve stimulator, classified under FDA regulation 21 CFR 890.5850. This device delivers electrical stimulation to nerve pathways through the skin, intended for over-the-counter use in managing neurological conditions. It operates as a non-invasive therapeutic tool, targeting pain relief or muscle stimulation without surgical intervention. The device falls under the product code NUH, designated for nerve stimulators under the neurology specialty.
The Xiniwave Model XW-18 is supplied as a reusable medical device, requiring no sterilisation between uses. It is designed for clinical and home use settings, adhering to FDA 510(k) clearance (K100441) under the Traditional review pathway. The device is regulated under the Neurology advisory committee and is intended for use in accordance with its approved indications as a transcutaneous nerve stimulator. Storage and operational details are not specified in the regulatory data, but compliance with manufacturer instructions is required for safe use.
Frequently asked questions
What is the Xiniwave Model XW-18 used for?
The Xiniwave Model XW-18 is a transcutaneous nerve stimulator designed to deliver electrical stimulation through the skin. It is intended for managing neurological conditions by providing non-invasive pain relief or muscle stimulation, making it suitable for both clinical and home use settings.
Is the Xiniwave XW-18 reusable or single-use?
The Xiniwave XW-18 is a reusable medical device. It does not require sterilization between uses, allowing for repeated application as long as manufacturer guidelines are followed for safe and effective operation.
What regulatory pathway does the Xiniwave XW-18 follow?
The Xiniwave XW-18 has received FDA 510(k) clearance under the Traditional review pathway, specifically under product code NUH for nerve stimulators in neurology. It was reviewed by the Neurology Advisory Committee and is classified under 21 CFR 890.5850.
Can the Xiniwave XW-18 be used at home?
Yes, the Xiniwave XW-18 is designed for both clinical and home use. It is intended for over-the-counter application, allowing users to manage pain or muscle stimulation independently under the guidance of its approved indications.
What storage requirements apply to the Xiniwave XW-18?
The regulatory data does not specify detailed storage requirements for the Xiniwave XW-18. However, compliance with the manufacturer’s instructions is essential to ensure safe and effective use, including proper handling and storage conditions.
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: XINIWAVE, MODEL XW-18 (K100441) — FDA 510(k) | Innolitics, Xiniwave, Model Xw-18 510 (k) FDA Premarket Notification K100441 ..., Download Now: FDA 510(k), K100441, XINIWAVE, MODEL XW-18
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K100441 | Class II | Active |
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Manufacturer
- Manufacturer
- International Trade Group Inc
- FDA Applicant
- International Trade Group, Inc.
Sources (1)
- FDA 510(k) K100441 24 fields · synced Oct 5, 2026