Identifiers
- 510(k) Number
- K110636 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 Tula Iontophoresis System is an iontophoresis device designed to deliver drug solutions, salts, or ions into the ear and tympanic membrane using electric current. The system consists of an iontophoresis control unit, iontophoresis earsets, and a return electrode patch.
This single-use device is supplied with accessories including a syringe and earset sizers. It is regulated under FDA 510(k) clearance with the product code EGJ and regulation number 890.5525.
Frequently asked questions
What is the Tula Iontophoresis System used for?
This system is designed to deliver drug solutions, salts, or ions into the ear and tympanic membrane through the application of an electric current.
Is the Tula Iontophoresis System intended for single-use?
Yes, the Tula Iontophoresis System is a single-use device. It is supplied with necessary accessories, including a syringe and earset sizers, to facilitate the procedure.
What components are included with the system?
The system consists of an iontophoresis control unit, iontophoresis earsets, and a return electrode patch. It also comes with accessories such as a syringe and earset sizers to support clinical use.
What is the regulatory status of this device?
The Tula Iontophoresis System is regulated under FDA 510(k) clearance, identified by product code EGJ and regulation number 890.5525.
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: Tula – Wikipedia, PDF Acclarent, Inc. Pavan Sethi, PhD Manager, Regulatory Affairs 1525-B O ..., TULA Iontophoresis System with Earset (K150453) — FDA 510(k ..., TULA IONTOPHORESIS SYSTEM (K110636) — 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 | K110636 | Class II | Active |
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Manufacturer
- Manufacturer
- Acclarent, Inc.
Sources (1)
- FDA 510(k) K110636 24 fields · synced Sep 21, 2026