510(k) K992708 ยท EGJ Device, Iontophoresis, Other Uses
IONTOPATCH
| Applicant | Birch Point Medical, Inc., Roseville MN, US |
| Decision | Substantially Equivalent, Feb 1, 2000 |
| Received | Aug 11, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K992708
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 29, 2025 | LTS Therapy Systems, LLC IontoPatch STAT, On-the-Go Patch Therapy, Model/Catalog Number D-0062-080; IontoPatch is an Iontophoresis transdermal patch. Open, Classified |
EGJ | None listed |
| Jul 29, 2025 | LTS Therapy Systems, LLC IontoPatch 80, On-the-Go Patch Therapy, Model/Catalog Number: D-0077-080;
The IontoPatch is an Iontophoresis transdermal patch. Open, Classified |
EGJ | None listed |
| Nov 10, 2021 | Tapemark Company iontoPATCH On-the-Go Patch Therapy, Transdermal Iontophoretic Drug Delivery System, Extra Strength, 8-HOUR Average Wear Time, 6/1-patch pouches/box. Dosage: 120mA/min. Terminated |
EGJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.