Dupel Transport Iontophoresis System
FDA 510(k)Class II (US FDA 510(k))
by Empi
Identifiers
- 510(k) Number
- K070427 FDA 510(k)
- FDA Product Code
- EGJ FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 890.5525 FDA 510(k)
- Regulation Number
- 890.5525 FDA 510(k)
- Advisory Committee
- Physical Medicine FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Dupel Transport Iontophoresis System is a Class II disposable, single-use device designed for the local administration of ionic solutions via iontophoresis. It employs a self-contained battery and electrical circuitry to facilitate transdermal delivery of charged molecules, enabling targeted therapeutic or diagnostic applications in physical medicine.
The system comprises a power module, delivery electrode, return electrode, and lead wires, all intended for one-time use. Supplied as a sterile, non-reusable device, it adheres to FDA 510(k) clearance under the Physical Medicine advisory committee. Storage and handling follow standard single-use medical device protocols, with regulatory compliance ensured by the assigned K070427 product code and EGJ classification.
Frequently asked questions
What is the Dupel Transport Iontophoresis System used for in clinical practice?
The Dupel Transport Iontophoresis System is designed for the local administration of ionic solutions through the skin using iontophoresis. This technique delivers charged molecules transdermally, supporting targeted therapeutic or diagnostic applications in physical medicine, such as reducing localized swelling or facilitating drug delivery for conditions like hyperhidrosis or muscle pain.
Is the Dupel Transport Iontophoresis System reusable, or is it intended for single-use only?
The system is explicitly labeled as a disposable, single-use device. All components—including the power module, electrodes, and lead wires—are intended for one-time use only, adhering to standard single-use medical device protocols to ensure sterility and safety.
How should the Dupel Transport Iontophoresis System be stored before use?
Since it is a sterile, single-use device, storage follows standard protocols for medical disposables. It should be kept in a clean, dry environment, protected from physical damage or contamination, and used within the manufacturer’s specified shelf life to maintain performance and sterility.
What regulatory pathway was followed for FDA clearance of this device?
The Dupel Transport Iontophoresis System received FDA 510(k) clearance under the Physical Medicine advisory committee via a traditional review process. It was determined to be substantially equivalent to a predicate device, with the assigned product code K070427 and classification EGJ under regulation 890.5525.
Are there multiple sizes or models available for the Dupel Transport Iontophoresis System?
The provided data does not specify distinct sizes or models beyond the core components (power module, electrodes, and lead wires). However, the system is designed as a unified, single-use setup for localized iontophoresis applications, with no indication of modular or interchangeable parts.
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: DUPEL TRANSPORT IONTOPHORESIS SYSTEM (K070427) — FDA 510 (k ..., DUPEL TRANSPORT IONTOPHORESIS SYSTEM by EMPI | FDA 510 (k) Summary, PDF V01.00 Ko-7oYZ-7 - Food and Drug Administration
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K070427 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Empi
Sources (1)
- FDA 510(k) K070427 24 fields · synced Sep 19, 2026