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Physical Medicine › TherapeuticDevice, 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.

Registry build 21.09.26

2manufacturers in China registered for this device type

1catalogue number

11510(k) clearances naming this product code

Who Else Makes It

Concentrated in Zhejiang (1), Guangdong (1).

Chinese manufacturers registered for FDA product code EGJ
Manufacturer	City	Province	Registered as	Device types
Top-rank Health Care Co., Ltd.	Shaoxing	Zhejiang	Contract manufacturer	7
General Meditech, Inc.	Shenzhen	Guangdong	Complaint-file establishment	3

Record

Regulatory record for Iontophoresis Dupel Blue Medium – Standard 2.5 mL
Listed by	Empi, United States
FDA product code	EGJ
Device type	Device, Iontophoresis, Other Uses
Device class	Class 2
Regulation	21 CFR 890.5525
Record published	2014-09-24
Record revised	2018-03-29 (version 2)

Specifications

Specifications
MRI safety	MR Unsafe
Single use	Yes
Prescription	Prescription only
Label carries	lot or batch number, expiry date

Catalogue Numbers

Catalogue numbers for Iontophoresis Dupel Blue Medium – Standard 2.5 mL
Catalogue number	Size	Status
199335-001		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Drionic TM	General Meditech, Inc.	15
Chattanooga	DJO, LLC	13
Richmar	South Dakota Partners	12
BodyMed Iontophoresis Electrode Kit	Drive DeVilbiss Healthcare	8
Trivarion	Activatek, Inc.	4
Norco	Activatek, Inc.	4
Performa	Performance Health Supply, Inc.	4
BodyMed	Boxout, LLC	4
IontoPatch	LTS Therapy Systems, LLC	4
Dupel Blue	Clearlake-Tech Inc	4
Ionto480 Buffered Iontophoresis Electrode Treatment Kit	Axelgaard Manufacturing Co., Ltd.	4
ActivaTek Ionto4 Kit	North Coast Medical, Inc.	3

Showing 12 of 68. All products under Device, Iontophoresis, Other Uses

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K072946	2007-11-16
K070427	2007-05-14
K030395	2003-04-08
K991991	1999-09-10
K983484	1998-12-28
K970491	1997-05-30
K915444	1994-07-15
K912015	1991-11-15
K912014	1991-10-28
K903093	1990-10-11
K896703	1990-02-26

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.