FDA.reportPublic FDA data

Dynatron® ion™ Medium

Primary DI
20660584000083
Brand
Dynatron® ion™ Medium
Company
Dynatronics Corporation
Model
ION-M
Published
2015-11-20
Public version status
Update
Distribution status
Not 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
K060814000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K060814000DYNATRON ION IONTOPHORESIS ELECTRODEDynatronics Corp.2006-06-14EGJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20660584000083PrimaryGS10
10660584000086Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2066058400008320660584000083
1066058400008610660584000086

GMDN Terms#

Term, Definition table
TermDefinition
Iontophoresis system electrode, returnA non-sterile, non-active, electrical conductor that is fastened to a patient and connected to an iontophoresis system (e.g., typically the current generator), to create a circuit for the return of electrical current after its emission for the therapeutic transport of ions to the patient. It is fastened to the patient's body typically where the greatest effect can be achieved with respect to the active electrode. It will typically be designed with a detachable lead wire and comes in a variety of sizes. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Area/Surface Area1.3Square inch

Storage And Handling#

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

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
8008746251info@dynatron.com

Regulatory Flags#

DUNS number
113399125
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10660584000017Dynatron Solaris Plus 709D719T2016-09-24
10660584000024Dynatron Solaris Plus 708D718T2016-09-24
10660584000031Dynatron Solaris Plus 707D7172016-09-24
10660584000048Dynatron Solaris Plus 706D716T2016-09-24
10660584000055Dynatron Solaris Plus 705D715T2016-09-24
10660584000109Dynatron 25 Series 925BD925T2016-09-24
10660584000116Dynatron 25 Series 825BD825T2016-09-24
10660584000123Dynatron 25 Series 625BD625T2016-09-24
10660584000130Dynatron 25 Series 525BD525T2016-09-24
10660584000338Dynatron Solaris Plus 709D7192016-09-24
10660584000918DynaGel™ Ultrasound Gel, 5 Liters, Clear5LTRGEL5LTRGEL2016-11-18
10660584000222DynaGel™ Ultrasound Gel, 5 Liters, Blue5LTRGEL-B5LTRGEL-B2016-11-18
10660584000895DynaGel™ Ultrasound Gel, sample7B02177B02172016-11-18
10660584000901DynaGel™ Ultrasound Gel, 5 Liters, Blue5LTRGEL-B2018-10-18
10660584000925Dynatron® Lotion, 1 GallonDL1DL12016-11-18
10660584000277Dynatron Soundhead WSH022016-09-24
10660584000284Dynatron SoundheadWSH052016-09-24
10660584000291Dynatron Soundhead `WSH102016-09-24
10660584000185Solaris Soundhead9GSH022016-09-24
10660584000192Solaris Soundhead9GSH052016-09-24

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