Product code KTB
- Device name
- Device, Iontophoresis, Specific Uses
- Medical specialty
- Physical Medicine
- Device class
- 2
- Regulation number
- 890.5525
- Review panel
- PM
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K180627 | Macroduct Advanced Model 3710 | Elitechgroup, Inc. | 2018-07-27 |
| K033192 | RH-950 | Iomed, Inc. | 2003-12-22 |
| K031551 | NORTHSTAR LIDOCAINE IONTOPHORETIC CONTROLLER (NORTHSTAR CONTROLLER-D) | Vyteris, Inc. | 2003-08-20 |
| K031115 | RH-900 | Iomed, Inc. | 2003-07-10 |
| K010031 | NANODUCT NEONATAL SWEAT ANALYSIS SYSTEM | Wescor, Inc. | 2001-03-20 |
| K001522 | TRANSQ3 | Iomed, Inc. | 2000-10-18 |
| K001410 | PHORESOR MODEL PM2000 | Iomed, Inc. | 2000-08-01 |
| K992874 | Q-SWEAT QUANTITATIVE SWEAT MEASUREMENT SYSTEM | Wr Medical Electronics Co. | 1999-11-18 |
| K974855 | PHORESOR II, MODEL PM900 | Iomed, Inc. | 1998-03-27 |
| K954126 | TRANSQ ELECTRODE PHORESOR II | Iomed, Inc. | 1996-01-19 |
| K895775 | CF INDICATOR MODEL 9800 SWEAT TEST SYSTEM | Medtronic Vascular | 1990-04-23 |
| K853973 | WESCOR MODEL 3700 WEBSTER SWEAT INDUCER | Wescor, Inc. | 1985-10-16 |
| K840472 | SYS MACRODUCT SWEAT COLLECTION SYS 3600 | Wescor, Inc. | 1984-03-19 |
| K832059 | IONOPHORELIC SWEAT STIM. CHLORIDE- | Medtronic Vascular | 1983-08-24 |
| K790205 | ELECTROAPPLICATOR MODEL C-1 | Mcg, Inc. | 1979-03-19 |
| K781700 | IONOTPHORETIC APPLICATOR | Mcghan Medical Corp. | 1978-11-03 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 03661540300400 | Macroduct Advanced Sweat Collection System | ELITECHGROUP INC. | 2025-02-27 |
| 03661540300370 | Macroduct Advanced Electrode Cable Assembly | ELITECHGROUP INC. | 2021-06-07 |
| 03661540302022 | Nanoduct® Electrode Cable Set Assembly | ELITECHGROUP INC. | 2021-02-22 |
| 03661540303241 | Nanoduct® Conductivity Sensor Cell, Qty 1 | ELITECHGROUP INC. | 2021-02-19 |
| 03661540302329 | Nanoduct® Supply Kit, Qty 6 | ELITECHGROUP INC. | 2021-02-19 |
| 03661540302015 | Nanoduct® Neg (-) Black Holder, Qty 1 | ELITECHGROUP INC. | 2021-02-19 |
| 03661540302008 | Nanoduct® Pos (+) Red Holder, Qty 1 | ELITECHGROUP INC. | 2021-02-19 |
| 03661540301995 | Nanoduct® Electrode Strap, Large, Qty 1 | ELITECHGROUP INC. | 2021-02-19 |
| 03661540301988 | Nanoduct® Electrode Strap, Medium, Qty 1 | ELITECHGROUP INC. | 2021-02-19 |
| 03661540301971 | Nanoduct® Electrode Strap, Small, Qty 1 | ELITECHGROUP INC. | 2021-02-19 |
| 03661540301964 | Nanoduct® Attachment Strap Retainer Post, Qty 1 | ELITECHGROUP INC. | 2021-02-19 |
| 03661540300349 | Macroduct® Advanced Strap Set, Qty 18 | ELITECHGROUP INC. | 2021-02-18 |
| 03661540300356 | Macroduct® Advanced Strap Set, Qty 180 | ELITECHGROUP INC. | 2021-02-18 |
| 03661540300363 | Macroduct® Advanced Electrode Cable Assembly | ELITECHGROUP INC. | 2021-02-18 |
| 03661540300530 | Macroduct® Black Electrode Strap, Qty 1 | ELITECHGROUP INC. | 2021-02-18 |
| 03661540300547 | Macroduct® Red Electrode Strap, Qty 1 | ELITECHGROUP INC. | 2021-02-18 |
| 03661540302084 | Macroduct® Pilogel Discs | ELITECHGROUP INC. | 2021-02-18 |
| 03661540302152 | Macroduct® Supply Kit, Qty 6 | ELITECHGROUP INC. | 2021-02-18 |
| 03661540302169 | Macroduct® Supply Kit, w/o Dye, Qty 6 | ELITECHGROUP INC. | 2021-02-18 |
| 03661540302770 | Macroduct® Collection Strap, Small, Qty 1 | ELITECHGROUP INC. | 2021-02-18 |
| 03661540300110 | Macroduct® Electrode Cable Assembly | ELITECHGROUP INC. | 2021-02-18 |
| 00888912151474 | CHATTANOOGA | DJO, LLC | 2014-09-24 |
| 00888912151467 | CHATTANOOGA | DJO, LLC | 2014-09-24 |
| 00888912151450 | CHATTANOOGA | DJO, LLC | 2014-09-24 |
| 00888912151436 | CHATTANOOGA | DJO, LLC | 2014-09-24 |
| 00888912151429 | CHATTANOOGA | DJO, LLC | 2014-09-24 |
| 00888912151412 | CHATTANOOGA | DJO, LLC | 2014-09-24 |
| 00888912151405 | CHATTANOOGA | DJO, LLC | 2014-09-24 |
| 00888912024082 | CHATTANOOGA | DJO, LLC | 2014-09-24 |
| 00888912024075 | CHATTANOOGA | DJO, LLC | 2014-09-24 |