Device, Iontophoresis, Specific Uses
FDA product code KTB · Class II (moderate risk) · 21 CFR 890.5525 · Physical Medicine
16510(k) clearances
0PMA approvals
0recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K180627 | Macroduct Advanced Model 3710KTB · Traditional | Elitechgroup, Inc. | 07/27/2018SE |
| K033192 | RH-950KTB · Traditional | Iomed, Inc. | 12/22/2003SE |
| K031551 | Northstar Lidocaine Iontophoretic Controller (Northstar Controller-D)KTB · Traditional | Vyteris, Inc. | 08/20/2003SE |
| K031115 | RH-900KTB · Traditional | Iomed, Inc. | 07/10/2003SE |
| K010031 | Nanoduct Neonatal Sweat Analysis SystemKTB · Special | Wescor, Inc. | 03/20/2001SE |
| K001522 | TRANSQ3KTB · Traditional | Iomed, Inc. | 10/18/2000SE |
| K001410 | Phoresor Model PM2000KTB · Traditional | Iomed, Inc. | 08/01/2000SE |
| K992874 | Q-Sweat Quantitative Sweat Measurement SystemKTB · Traditional | Wr Medical Electronics Co. | 11/18/1999SE |
| K974855 | Phoresor II, Model PM900KTB · Traditional | Iomed, Inc. | 03/27/1998SN |
| K954126 | Transq Electrode Phoresor IIKTB · Traditional | Iomed, Inc. | 01/19/1996SN |
| K895775 | CF Indicator Model 9800 Sweat Test SystemKTB · Traditional | Medtronic Vascular | 04/23/1990SE |
| K853973 | Wescor Model 3700 Webster Sweat InducerKTB · Traditional | Wescor, Inc. | 10/16/1985SE |
| K840472 | Sys Macroduct Sweat Collection Sys 3600KTB · Traditional | Wescor, Inc. | 03/19/1984SE |
| K832059 | Ionophorelic Sweat Stim. Chloride-KTB · Traditional | Medtronic Vascular | 08/24/1983SE |
| K790205 | Electroapplicator Model C-1KTB · Traditional | Mcg, Inc. | 03/19/1979SE |
| K781700 | Ionotphoretic ApplicatorKTB · Traditional | Mcghan Medical Corp. | 11/03/1978SE |