Device, Iontophoresis, Other Uses

Who Makes This Device Type in China?

Chinese manufacturers registered for this device type are based in Guangdong and Zhejiang: 2 hold an FDA registration.

General Meditech, Inc. Guangdong
Top-rank Health Care Co., Ltd. Zhejiang, contract manufacturer

How Is EGJ Classified?

Device, Iontophoresis, Other Uses is FDA product code EGJ, Class 2, 21 CFR 890.5525.

How Does It Reach the US Market?

A 510(k) premarket notification is required before it is sold in the United States: the applicant shows the device is substantially equivalent to one already on the market. Chinese applicants hold 1 clearance under this code; the FDA took 101 days from receipt to decision.

What Has Gone Wrong With It?

The FDA has recorded 7 recalls under this product code since 2005. None was by a company in China. The root causes the FDA records most often are Error in labeling (3) and Labeling Change Control (1).

A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.

Device, Iontophoresis, Other Uses

Iontophoresis Dupel Blue Medium – Standard 2.5 Ml

Catalogue number 199335-001, listed by Empi, United States, under Device, Iontophoresis, Other Uses. 2 manufacturers in China are registered for this product code.

Device, Iontophoresis, Other Uses

Ionto Plus Large Electrode

Iontophoresis Drug Delivery Large Kit Electrodes - 4.0 cc, 4mA-min incl. buffered return 3.5" x 3.5"

Device, Iontophoresis, Other Uses

Mattioli

Pulsed Iontophoresis Device with handpiece

Device, Iontophoresis, Other Uses

Dupel Kit Iontophoresis Device

Catalogue number 199518-001, listed by Empi, United States, under Device, Iontophoresis, Other Uses. 2 manufacturers in China are registered for this product code.

Device, Iontophoresis, Other Uses

Ionto Plus Medium Electrodes

Iontophoresis Drug Delivery Medium Kit Electrodes - 2.5cc, 4mA-min incl. buffered return 3.25" x 3.25"

Device, Iontophoresis, Other Uses

Kit Dupel II International Complete W/safety Socket

Catalogue number 199438-001, listed by Empi, United States, under Device, Iontophoresis, Other Uses. 2 manufacturers in China are registered for this product code.

Device, Iontophoresis, Other Uses

Kit, Hybresis Controller

Catalogue number 199587-001, listed by Empi, United States, under Device, Iontophoresis, Other Uses. 2 manufacturers in China are registered for this product code.

Device, Iontophoresis, Other Uses

Ionto Plus Small Electrode

Iontophoresis Drug Delivery Small Kit Electrodes - 1.5cc, 3mA-minute, incl. buffered return 2.75" x 2.75"

Device, Iontophoresis, Other Uses

Push Patch Controlled Released 12.0

Push Patch Controlled Released 12.0 - Private labeled ActivaPatch IontoGo 12.0 iontophoresis wireless electrode

Device, Iontophoresis, Other Uses

Action Patch Electrode ~ Box of 4

Catalogue number 199488-001, listed by Empi, United States, under Device, Iontophoresis, Other Uses. 2 manufacturers in China are registered for this product code.

Device, Iontophoresis, Other Uses

Iontophoresis Electrode Small 2.0 Ml 3.75″X2.25″ Box of 12

Catalogue number 198808-001, listed by Empi, United States, under Device, Iontophoresis, Other Uses. 2 manufacturers in China are registered for this product code.

Device, Iontophoresis, Other Uses

Hybresis Iontophoresis Patch, Medium/Standard, Box of 6

Catalogue number 199589-001, listed by Empi, United States, under Device, Iontophoresis, Other Uses. 2 manufacturers in China are registered for this product code.

Device, Iontophoresis, Other Uses

Daavlin

Daavlin Aquex Tap Water Iontophoresis Device

Device, Iontophoresis, Other Uses

Iontophoresis Dupel Blue Butterfly 2.0 Ml

Catalogue number 199334-001, listed by Empi, United States, under Device, Iontophoresis, Other Uses. 2 manufacturers in China are registered for this product code.

Device, Iontophoresis, Other Uses

ActivaTek Ionto4 Butterfly

ActivaTek Ionto4 Butterfly (12)

Device, Iontophoresis, Other Uses

ActivaPatch IontoGo 4.0 Sample

ActivaPatch IontoGo 4.0 Sample Pack (2)

Device, Iontophoresis, Other Uses

Norco Iontophoresis Medium & Butterfly Sample

Norco Buffered Iontophoretic Delivery Kit- Medium (1) and Butterfly (1) Sample Pack

Device, Iontophoresis, Other Uses

Norco Iontophoresis Small Sample

Norco Buffered Iontophoresis Delivery Kit- Small Sample Pack (2)

Device, Iontophoresis, Other Uses

Iontophoresis Electrode Medium Butterfly 2.0 Ml Box of 12

Catalogue number 199572-001, listed by Empi, United States, under Device, Iontophoresis, Other Uses. 2 manufacturers in China are registered for this product code.

Device, Iontophoresis, Other Uses

KIT, Dupel II, w/SAFETY Socket

Catalogue number 199437-001, listed by Empi, United States, under Device, Iontophoresis, Other Uses. 2 manufacturers in China are registered for this product code.

Device, Iontophoresis, Other Uses

Iontophoresis Dupel Blue Large 4.0 Ml

Catalogue number 199336-001, listed by Empi, United States, under Device, Iontophoresis, Other Uses. 2 manufacturers in China are registered for this product code.

Device, Iontophoresis, Other Uses

Iontophoresis Electrode Large 4.0 Ml 4″X4″ Box of 12

Catalogue number 198810-001, listed by Empi, United States, under Device, Iontophoresis, Other Uses. 2 manufacturers in China are registered for this product code.

Device, Iontophoresis, Other Uses

Ass’y, Kit, Hybresis Charging Station

Catalogue number 199586-001, listed by Empi, United States, under Device, Iontophoresis, Other Uses. 2 manufacturers in China are registered for this product code.

Device, Iontophoresis, Other Uses

Dynatron® Ion™ Large

2 catalogue numbers from ION-L, listed by Dynatronics Corp., United States, under Device, Iontophoresis, Other Uses. 2 manufacturers in China are registered for this product code.

Device, Iontophoresis, Other Uses

Phothera

Phothera Aquex Tap Water Iontophoresis Device Package (US)

Device, Iontophoresis, Other Uses

Iontophor®-II

Catalogue number 6111PM/DX, listed by WR Medical Electronics Co., United States, under Device, Iontophoresis, Other Uses. 2 manufacturers in China are registered for this product code.

Device, Iontophoresis, Other Uses

ActivaPatch

IntelliDose, 2.5 hour iontophoresis delivery

Device, Iontophoresis, Other Uses

Ionto Plus Butterfly, Box of 12

Catalogue number 201-452, listed by Drive DeVilbiss Healthcare, United States, under Device, Iontophoresis, Other Uses. 2 manufacturers in China are registered for this product code.

Device, Iontophoresis, Other Uses

Ionto480 Buffered Iontophoresis Electrode Treatment Kit

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…

Device, Iontophoresis, Other Uses

ActivaPatch IontoGo 12.0 Sample

ActivaPatch IontoGo 12.0 Sample Pack (2)

Device, Iontophoresis, Other Uses

Dynatron® Ion™ Small

2 catalogue numbers from ION-S, listed by Dynatronics Corp., United States, under Device, Iontophoresis, Other Uses. 2 manufacturers in China are registered for this product code.

Device, Iontophoresis, Other Uses

ActivaDose II

Iontophoresis Delivery Unit

Device, Iontophoresis, Other Uses

Dupel Blue

Iontophoresis Electrode, Medium Butterfly 2.0 mL

Device, Iontophoresis, Other Uses

Dynatron iBOX2

Catalogue number DIBOX2, listed by Dynatronics Corp., United States, under Device, Iontophoresis, Other Uses. 2 manufacturers in China are registered for this product code.

Device, Iontophoresis, Other Uses

Ionto Plus Butterfly 2.0 Cc

Catalogue number 201-439, listed by Drive DeVilbiss Healthcare, United States, under Device, Iontophoresis, Other Uses. 2 manufacturers in China are registered for this product code.

Device, Iontophoresis, Other Uses

Trivarion Small Sample

Trivarion Buffered Iontophoretic Delivery Kit- Small, 1.5cc Sample Pack (2)

Device, Iontophoresis, Other Uses

Meridian™ Iontophoretic Drug Delivery Electrode

2 catalogue numbers from 5191, listed by WR Medical Electronics Co., United States, under Device, Iontophoresis, Other Uses. 2 manufacturers in China are registered for this product code.

Device, Iontophoresis, Other Uses

Dynatron ION Butterfly

Box of 12

Device, Iontophoresis, Other Uses

Trivarion Medium & Butterfly Sample

Trivarion Buffered Iontophoretic Delivery Kit- Medium (1) and Butterfly (1) Sample Pack

Device, Iontophoresis, Other Uses

ActivaPatch IontoGo 12.0

ActivaPatch IontoGo 12.0 carton with 6 pouches, 12 hour iontophoresis delivery

Device, Iontophoresis, Other Uses

Dermadry

Dermadry is a tap-water iontophoresis device intended to treat excessive sweating of the hands, feet and underarms. It applies low-level direct current between the treatment areas. The…

Device, Iontophoresis, Other Uses

ActivaPatch IontoGo 4.0

ActivaPatch IontoGo 4.0 carton with 6 pouches. 4 hour iontophoresis delivery.

Device, Iontophoresis, Other Uses

Drionic TM

Drionic Underarm Applicator Modules

Device, Iontophoresis, Other Uses

Ionto Plus Medium, Box of 12

Catalogue number 201-449, listed by Drive DeVilbiss Healthcare, United States, under Device, Iontophoresis, Other Uses. 2 manufacturers in China are registered for this product code.

Device, Iontophoresis, Other Uses

BodyMed Iontophoresis Electrode Kit

8 catalogue numbers from Butterfly (3.75"x3.75"), listed by Drive DeVilbiss Healthcare, United States, under Device, Iontophoresis, Other Uses. 2 manufacturers in China are registered for this product code.

Device, Iontophoresis, Other Uses

The Fischer

Tap Water Iontophoresis Device for Treatment of Hyperhidrosis (Hands and Feet)

Device, Iontophoresis, Other Uses

Ionto Plus Large 4.0 Cc

Catalogue number 201-453, listed by Drive DeVilbiss Healthcare, United States, under Device, Iontophoresis, Other Uses. 2 manufacturers in China are registered for this product code.

Device, Iontophoresis, Other Uses

Iontophoresis Dupel Blue Small 1.5ml

Catalogue number 199332-001, listed by Empi, United States, under Device, Iontophoresis, Other Uses. 2 manufacturers in China are registered for this product code.

Device, Iontophoresis, Other Uses

Ionto Plus Medium 2.5 Cc

Catalogue number 201-438, listed by Drive DeVilbiss Healthcare, United States, under Device, Iontophoresis, Other Uses. 2 manufacturers in China are registered for this product code.

Device, Iontophoresis, Other Uses

Ionto Plus Small, Box of 12

Catalogue number 201-455, listed by Drive DeVilbiss Healthcare, United States, under Device, Iontophoresis, Other Uses. 2 manufacturers in China are registered for this product code.

Device, Iontophoresis, Other Uses

IontoPatch

The IontoPatch contains an innovative self-contained battery that produces an electric current to carry drug molecules non-invasively across the skin and to underlying tissue. There is no…

Device, Iontophoresis, Other Uses

Ionto Plus Large, Box of 12

Catalogue number 201-453, listed by Drive DeVilbiss Healthcare, United States, under Device, Iontophoresis, Other Uses. 2 manufacturers in China are registered for this product code.

Device, Iontophoresis, Other Uses

Ionto Plus Small 1.5 Cc

Catalogue number 201-440, listed by Drive DeVilbiss Healthcare, United States, under Device, Iontophoresis, Other Uses. 2 manufacturers in China are registered for this product code.

Device, Iontophoresis, Other Uses

Iontophoresis Electrode Medium 2.0 Ml 3″X3″ Box of 12

Catalogue number 198809-001, listed by Empi, United States, under Device, Iontophoresis, Other Uses. 2 manufacturers in China are registered for this product code.

Device, Iontophoresis, Other Uses

BodyMed

Bodymed Iontophoresis, Electrodes Butterfly 3.75" X 3.75", 12/BOX

Device, Iontophoresis, Other Uses

Performa

Performa VE - Small, 1.5 CC BOX OF 12

Device, Iontophoresis, Other Uses

Norco Iontophoresis Large Sample

Norco Buffered Iontophoretic Delivery Kit- Large Sample Pack (2)

Device, Iontophoresis, Other Uses

Fischer

Fischer Model MD-1a Galvanic unit

Device, Iontophoresis, Other Uses

Hidrex USA

HIDREX USA DVP1000 Iontophoresis Device Package Hand/Foot (Aluminum Electrode Plates, US Type A Plug)

Device, Iontophoresis, Other Uses

Norco

Buffered Iontophoretic Delivery Kit- Butterfly, 2.0cc

Device, Iontophoresis, Other Uses

Ionto Plus Butterfly

Iontophoresis Drug Delivery Butterfly Electrode, 2.0cc, 3mA-minute incl. buffered return 3.75" x 3.75"

Device, Iontophoresis, Other Uses

Trivarion

Buffered Iontophoretic Delivery Kit- Butterfly, 2.0cc

Device, Iontophoresis, Other Uses

Richmar

Richmar Butterfly Ionto4 Electrode, Bag of 12

Device, Iontophoresis, Other Uses

PushPatch Delicate (6)

Drug-delivery iontophoresis patch

Device, Iontophoresis, Other Uses

Chattanooga

Trans QE Medium 2.5-3.0 cc electrode, Box of 12

Device, Iontophoresis, Other Uses

ActivaTek Ionto4 Kit

ActivaTek Ionto4 Kit MD (12)

Device, Iontophoresis, Other Uses

Dynatron® Ion™ Medium

2 catalogue numbers from ION-M, listed by Dynatronics Corp., United States, under Device, Iontophoresis, Other Uses. 2 manufacturers in China are registered for this product code.

Device, Iontophoresis, Other Uses

Trivarion Large Sample

Trivarion Buffered Iontophoretic Delivery Kit- Large Sample Pack (2)

Device, Iontophoresis, Other Uses

ActivaPatch IntelliDose 2.5 Sample

ActivaPatch IntelliDose 2.5 Sample Pack (2)

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China

2,581device types they are registered for

340,248device records, each naming its maker

31provinces with a registered manufacturer