Panels › Physical Medicine › Product code KTB · Class 2
Device, Iontophoresis, Specific Uses
Regulation 890.5525
0510(k)s in 12 months (16 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in KTB
| Company | 510(k)s | Recalls |
|---|---|---|
| Iomed, Inc. | 6 | 0 |
| Wescor, Inc. | 3 | 0 |
| Medtronic Vascular | 2 | 0 |
| Elitechgroup, Inc. | 1 | 0 |
| Mcg, Inc. | 1 | 0 |
| Mcghan Medical Corp. | 1 | 0 |
| Vyteris, Inc. | 1 | 0 |
| Wr Medical Electronics Co. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 27, 2018 | K180627 | Macroduct Advanced Model 3710 Elitechgroup, Inc. | KTB |
| Dec 22, 2003 | K033192 | RH-950 Iomed, Inc. | KTB |
| Aug 20, 2003 | K031551 | NORTHSTAR LIDOCAINE IONTOPHORETIC CONTROLLER (NORTHSTAR CONTROLLER-D) Vyteris, Inc. | KTB |
| Jul 10, 2003 | K031115 | RH-900 Iomed, Inc. | KTB |
| Mar 20, 2001 | K010031 | NANODUCT NEONATAL SWEAT ANALYSIS SYSTEM Wescor, Inc. | KTB |
| Oct 18, 2000 | K001522 | TRANSQ3 Iomed, Inc. | KTB |
| Aug 1, 2000 | K001410 | PHORESOR MODEL PM2000 Iomed, Inc. | KTB |
| Nov 18, 1999 | K992874 | Q-SWEAT QUANTITATIVE SWEAT MEASUREMENT SYSTEM Wr Medical Electronics Co. | KTB |
| Mar 27, 1998 | K974855 | PHORESOR II, MODEL PM900 Iomed, Inc. | KTB |
| Jan 19, 1996 | K954126 | TRANSQ ELECTRODE PHORESOR II Iomed, Inc. | KTB |
| Apr 23, 1990 | K895775 | CF INDICATOR MODEL 9800 SWEAT TEST SYSTEM Medtronic Vascular | KTB |
| Oct 16, 1985 | K853973 | WESCOR MODEL 3700 WEBSTER SWEAT INDUCER Wescor, Inc. | KTB |
| Mar 19, 1984 | K840472 | SYS MACRODUCT SWEAT COLLECTION SYS 3600 Wescor, Inc. | KTB |
| Aug 24, 1983 | K832059 | IONOPHORELIC SWEAT STIM. CHLORIDE- Medtronic Vascular | KTB |
| Mar 19, 1979 | K790205 | ELECTROAPPLICATOR MODEL C-1 Mcg, Inc. | KTB |
| Nov 3, 1978 | K781700 | IONOTPHORETIC APPLICATOR Mcghan Medical Corp. | KTB |
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