FDA.reportPublic FDA data

Ionto480 Buffered Iontophoresis Electrode Treatment Kit

Primary DI
00856817005901
Brand
Ionto480 Buffered Iontophoresis Electrode Treatment Kit
Company
AXELGAARD MANUFACTURING CO., LTD.
Model
Ionto480 DDL350
Catalog number
DDL350
Device 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.
Published
2014-09-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EGJDevice, Iontophoresis, Other Uses

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EGJDevice, Iontophoresis, Other UsesPhysical Medicine2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K080580000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K080580000COMFORT IONTOPHORESIS ELECTRODES/ BUFFERED IONTOPHORESIS ELECTRODE TREATMENT, MODEL SMALL DDS275, MEDIUM DDM325, LARGE DAxelgaard Mfg. Co., Ltd.2008-06-18EGJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00856817005901PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00856817005901008568170059018568170059010856817005901

GMDN Terms#

Term, Definition table
TermDefinition
Drug-delivery iontophoresis patchA 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 injections for the transport of ionic-solution medication (e.g., soluble salts) through the movement of ions, resulting from an applied electric field, to locally administer the medication transcutaneously (transdermal). It typically consists of a positive and a negative electrode, a reservoir/drug chamber(s) that hold the medication, a battery, and a perimeter adhesive; the reservoir must be filled by the user with the drug prior to use. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature41 Degrees Fahrenheit80.6 Degrees Fahrenheit
Storage Environment Temperature41 Degrees Fahrenheit80.6 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
9999999999support@axelgaard.com

Regulatory Flags#

DUNS number
150959401
Device count
1
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
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03770018808345UltraStimactiTENSSBM1AC0092026-04-15
03770018808338UltraStimactiTENSSBM1AC0062024-10-28
00856817005413PALS8791002016-03-31
00856817005420PALS8792002016-03-31
00856817005437PALS8793002016-03-31
00856817005451PALS8912002016-03-31
00856817005468PALS8952202016-03-31
00856817005475PALS8952402016-03-31
00856817005482PALS8954022016-03-31
00856817005499PALS8952502016-03-31
00856817005505PALS8953402016-03-31
00856817005512PALS8962302016-03-31
00856817005536PALS8963502016-03-31
00856817005567PALS Foam9752002016-03-31
00856817005574PALS Foam9752202016-03-31
00856817005581PALS Foam9752402016-03-31
00856817005628PALS Foam9763502016-03-31
00851913006364UltraStim Snap DermaSND20202024-09-18
00851913006203EconoStimESB50002020-01-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10768627016497Push Patch Controlled Released 12.0NORTH COAST MEDICAL, INC.EGJ2025-12-01
00768627016995PushPatch Delicate (6)NORTH COAST MEDICAL, INC.EGJ2025-12-01
00768627016988PushPatch Delicate (6)NORTH COAST MEDICAL, INC.EGJ2025-12-01
20768627016494Push Patch Controlled Released 12.0NORTH COAST MEDICAL, INC.EGJ2025-12-01
10768627016299ActivaTek Ionto4 KitNORTH COAST MEDICAL, INC.EGJ2025-04-02
10768627016305ActivaTek Ionto4 KitNORTH COAST MEDICAL, INC.EGJ2025-04-02
10768627016312ActivaTek Ionto4 ButterflyNORTH COAST MEDICAL, INC.EGJ2025-04-02
10768627016282ActivaTek Ionto4 KitNORTH COAST MEDICAL, INC.EGJ2025-04-02
20768627016296ActivaTek Ionto4 KitNORTH COAST MEDICAL, INC.EGJ2025-04-02
20768627016302ActivaTek Ionto4 KitNORTH COAST MEDICAL, INC.EGJ2025-04-02
20768627016319ActivaTek Ionto4 ButterflyNORTH COAST MEDICAL, INC.EGJ2025-04-02
04250571300832PhotheraHIDREX GmbHEGJ2025-01-07
08054383090006MATTIOLIMATTIOLI ENGINEERING ITALIA SPAEGJ2024-09-26
00850030915047Dupel BLUEClearlake-Tech Inc.EGJ2023-08-02
00850030915078Dupel BLUEClearlake-Tech Inc.EGJ2023-08-02
00850030915108Dupel BLUEClearlake-Tech Inc.EGJ2023-08-02
00850030915252RichmarSouth Dakota Partners Inc.EGJ2023-08-02
00850030915269RichmarSouth Dakota Partners Inc.EGJ2023-08-02
00850030915276RichmarSouth Dakota Partners Inc.EGJ2023-08-02
00850030915283RichmarSouth Dakota Partners Inc.EGJ2023-08-02
00850030915290RichmarSouth Dakota Partners Inc.EGJ2023-08-02
00850030915306RichmarSouth Dakota Partners Inc.EGJ2023-08-02
00850030915313RichmarSouth Dakota Partners Inc.EGJ2023-08-02
00850030915320RichmarSouth Dakota Partners Inc.EGJ2023-08-02
00850030915337RichmarSouth Dakota Partners Inc.EGJ2023-08-02
00850030915344RichmarSouth Dakota Partners Inc.EGJ2023-08-02
00850030915351RichmarSouth Dakota Partners Inc.EGJ2023-08-02
00850030915368RichmarSouth Dakota Partners Inc.EGJ2023-08-02
00850030915016Dupel BLUEClearlake-Tech Inc.EGJ2023-08-02
00850030915054Dupel BLUESouth Dakota Partners Inc.EGJ2023-08-02