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Ionto480 Buffered Iontophoresis Electrode Treatment Kit
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- Ionto480 Buffered Iontophoresis Electrode Treatment Kit FDA UDI
- Generic Name
- Drug-delivery iontophoresis patch FDA UDI
- Device Name
- A non-sterile device designed as a patch that is fixed on the skin, typically with a pressure-sensitive adhesive intended to be used as an alternative to injection for the transport of ionic-solutions medication through the movement of ions, resulting from an applied electric field to locally administer the medication transcutaneously. It typically consists of a positive and a negative electrode, a reservoir/drug chamber that holds the medication. The reservoir must be filled by the user with drug prior to use. This is a single-use device. FDA UDI
- Model / Reference
- Ionto480 DDS275 FDA UDI
- Description
- A non-sterile device designed as a patch that is fixed on the skin, typically with a pressure-sensitive adhesive intended to be used as an alternative to injection for the transport of ionic-solutions medication through the movement of ions, resulting from an applied electric field to locally administer the medication transcutaneously. It typically consists of a positive and a negative electrode, a reservoir/drug chamber that holds the medication. The reservoir must be filled by the user with drug prior to use. This is a single-use device. FDA UDI
Identifiers
- Catalog Number
- DDS275 FDA UDI
- Primary DI / UDI-DI
- 00856817005888 FDA UDI
- 510(k) Number
- K080580 FDA UDI
- FDA Product Code
- EGJ FDA UDI
- GMDN Term
- Drug-delivery iontophoresis patch FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 890.5525 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Drug-delivery iontophoresis patch
Ionto480 Buffered Iontophoresis Electrode Treatment Kit by Axelgaard Manufacturing Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID
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Cleared under the same submission
K080580 also covers:
- Ionto480 Buffered Iontophoresis Electrode Treatment Kit — AXELGAARD MANUFACTURING CO., LTD.
- Ionto480 Buffered Iontophoresis Electrode Treatment Kit — AXELGAARD MANUFACTURING CO., LTD.
- Ionto480 Buffered Iontophoresis Electrode Treatment Kit — AXELGAARD MANUFACTURING CO., LTD.
- BodyMed — BOXOUT, LLC
- BodyMed — BOXOUT, LLC
- BodyMed — BOXOUT, LLC
- BodyMed — BOXOUT, LLC
- PERFORMA — Performance Health Supply, LLC
- PERFORMA — Performance Health Supply, LLC
- PERFORMA — Performance Health Supply, LLC
- PERFORMA — Performance Health Supply, LLC
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Axelgaard Manufacturing Co., Ltd.
Sources (1)
- FDA UDI 9a80fe05-d24a-4987-9fae-68de6aa7d962 38 fields · synced Jun 1, 2026