Data / Medical devices / Device, Iontophoresis, Specific Uses
Device, Iontophoresis, Specific Uses (KTB): 5 FDA-registered makers in 1 country
5 establishments in 1 country are registered with the FDA to make Device, Iontophoresis, Specific Uses (product code KTB, Class 2, 21 CFR 890.5525). 3 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 16 510(k) clearances under this code, the latest on July 27, 2018, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- KTB
- Device class
- 2
- Regulation
- 890.5525
- Medical specialty
- Physical Medicine
Makers by country
| Country | Makers |
|---|---|
| United States | 5 |
Makers of Device, Iontophoresis, Specific Uses
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Djo, LLC | Carlsbad, CA, United States | Specification developer | 6 | December 22, 2003 | 0 | 0 | 0 | api.fda.gov |
| ELITechGroup Inc | Logan, UT, United States | Manufacturer | 3 | July 27, 2018 | 0 | 0 | 0 | api.fda.gov |
| WR Medical Electronics Co. | Maplewood, MN, United States | Manufacturer | 1 | November 18, 1999 | 0 | 0 | 0 | api.fda.gov |
| Amrex-Zetron, Inc. | Paramount, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Clearlake-Tech Inc | Clear Lake, SD, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated July 27, 2018. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.