KTBClass II
Device, Iontophoresis, Specific Uses
Physical Medicine · 21 CFR 890.5525
MDR events40All time
Recalls0All time
Registered firms13Currently listed
510(k) clearances16All time
Recent MDR events
40 adverse event reports on file
- DUPEL IONTOPHORESIS DEVICEFeb 17, 2012Empi2466956
- *Aug 1, 2011MalfunctionWescor, Inc.2192411
- *Apr 22, 2010MalfunctionC&s Electronics Inc1671364
- IOGELMay 22, 2009Injury1022819-2009-00147
- MACRODUCT SYSTEM (SWEAT CHLORIDE TEST/ PILOGEL DISCS)Feb 3, 2009Wescor, Inc.1311849
- IOMED COMPANION 80Mar 24, 2008InjuryIomed, Inc.MW5006007
- PERFORMAVENov 6, 2007MalfunctionPatterson Medical940106
- PERFORMAVENov 6, 2007MalfunctionPatterson Medical940107
- MACRODUCTJun 19, 2007MalfunctionWescor, Inc.871066
- IONTOPHORESIS SWEAT CHLORIDE GIBSON COOKE SWEAT TEST APPARATJan 9, 2007MalfunctionFarrall Instruments813719
Event type breakdown
Malfunction17
Other11
Injury9
Unspecified3
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
13 firms currently registered for this product code
510(k) clearances
16 clearances for this product code
- Elitechgroup, Inc.Jul 27, 2018
K180627 · Macroduct Advanced Model 3710
- Iomed, Inc.Dec 22, 2003
K033192 · RH-950
- Vyteris, Inc.Aug 20, 2003
K031551 · NORTHSTAR LIDOCAINE IONTOPHORETIC CONTROLLER (NORTHSTAR CONTROLLER-D)
- Iomed, Inc.Jul 10, 2003
K031115 · RH-900
- Wescor, Inc.Mar 20, 2001
K010031 · NANODUCT NEONATAL SWEAT ANALYSIS SYSTEM
- Iomed, Inc.Oct 18, 2000
K001522 · TRANSQ3
- Iomed, Inc.Aug 1, 2000
K001410 · PHORESOR MODEL PM2000
- Wr Medical Electronics Co.Nov 18, 1999
K992874 · Q-SWEAT QUANTITATIVE SWEAT MEASUREMENT SYSTEM