KTB — Device, Iontophoresis, Specific Uses Class II
FDA product code KTB covers "Device, Iontophoresis, Specific Uses", a Class II medical device regulated under 21 CFR 890.5525. Submissions are reviewed by the Physical Medicine panel. At least 16 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- KTB
- Device Class
- Class II
- Regulation Number
- 890.5525
- Submission Type
- Review Panel
- PM
- Medical Specialty
- Physical Medicine
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K180627 | elitechgroup | Macroduct Advanced Model 3710 | July 27, 2018 |
| K033192 | iomed | RH-950 | December 22, 2003 |
| K031551 | vyteris | NORTHSTAR LIDOCAINE IONTOPHORETIC CONTROLLER (NORTHSTAR CONTROLLER-D) | August 20, 2003 |
| K031115 | iomed | RH-900 | July 10, 2003 |
| K010031 | wescor | NANODUCT NEONATAL SWEAT ANALYSIS SYSTEM | March 20, 2001 |
| K001522 | iomed | TRANSQ3 | October 18, 2000 |
| K001410 | iomed | PHORESOR MODEL PM2000 | August 1, 2000 |
| K992874 | wr medical electronics | Q-SWEAT QUANTITATIVE SWEAT MEASUREMENT SYSTEM | November 18, 1999 |
| K974855 | iomed | PHORESOR II, MODEL PM900 | March 27, 1998 |
| K954126 | iomed | TRANSQ ELECTRODE PHORESOR II | January 19, 1996 |
| K895775 | medtronic vascular | CF INDICATOR MODEL 9800 SWEAT TEST SYSTEM | April 23, 1990 |
| K853973 | wescor | WESCOR MODEL 3700 WEBSTER SWEAT INDUCER | October 16, 1985 |
| K840472 | wescor | SYS MACRODUCT SWEAT COLLECTION SYS 3600 | March 19, 1984 |
| K832059 | medtronic vascular | IONOPHORELIC SWEAT STIM. CHLORIDE- | August 24, 1983 |
| K790205 | mcg | ELECTROAPPLICATOR MODEL C-1 | March 19, 1979 |
| K781700 | mcghan medical | IONOTPHORETIC APPLICATOR | November 3, 1978 |