Transcutaneous Electrical Nerve Stimulator KTR-405
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K220998 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 Transcutaneous Electrical Nerve Stimulator KTR-405 is a device classified as a Transcutaneous Electrical Nerve Stimulator (Product Code: NUH), designed to deliver controlled electrical impulses through the skin to modulate pain perception or stimulate nerve pathways. It operates via surface electrodes applied to targeted anatomical sites, providing non-invasive therapeutic modulation for conditions such as chronic pain, muscle spasms, or neurological dysfunction.
This device is supplied as a reusable medical instrument, intended for clinical use in settings such as outpatient clinics, physical therapy centers, or home care environments. The KTR-405 is not sterile and requires proper cleaning and maintenance between uses, adhering to manufacturer guidelines for electrical safety and hygiene. It has been authorized under FDA 510K clearance (K220998) and MDR compliance, with regulatory oversight by the Neurology (NE) advisory committee. Storage conditions must follow electrical device protocols to ensure functionality and patient safety.
Frequently asked questions
Is the KTR-405 device intended for single-use or can it be reused in clinical settings?
The KTR-405 is designed as a reusable medical instrument for clinical use, such as in outpatient clinics, physical therapy centers, or home care. Since it is not sterile, it requires proper cleaning and maintenance between uses to ensure hygiene and electrical safety, following the manufacturer’s guidelines.
How should the KTR-405 be stored to maintain its functionality and safety?
The KTR-405 must be stored according to standard electrical device protocols to preserve its functionality and ensure patient safety. This includes protecting it from moisture, extreme temperatures, and physical damage, as outlined in the manufacturer’s instructions.
What types of conditions is the KTR-405 intended to address, and how does it work?
The KTR-405 is intended to modulate pain perception or stimulate nerve pathways for conditions like chronic pain, muscle spasms, or neurological dysfunction. It achieves this by delivering controlled electrical impulses through surface electrodes applied to specific anatomical sites, providing a non-invasive therapeutic effect.
What regulatory pathways has the KTR-405 followed, and which advisory committee was involved?
The KTR-405 has undergone FDA 510(k) clearance (K220998) and MDR compliance, with regulatory oversight by the Neurology (NE) advisory committee. The device was deemed substantially equivalent under the traditional clearance pathway, ensuring its safety and performance meet established standards.
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 | K220998 | Class II | Active |
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Manufacturer
- Manufacturer
- Shenzhen Kentro Medical Electronics Co., Ltd
- FDA Applicant
- Shenzhen Kentro Medical Electronics Co., Ltd.
Sources (2)
- FDA 510(k) K220998 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 18, 2026