Data / Medical devices / United States / LTS Therapy Systems, LLC
LTS Therapy Systems, LLC: FDA-registered device maker in West St Paul, MN, United States, 1 510(k) clearance
LTS Therapy Systems, LLC is registered with the FDA (registration 2182681) in West St Paul, MN, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated February 1, 2000. 2 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 2182681
- Address
- 1685 Marthaler LN., West St Paul, MN, United States, 55118
- Owner or operator
- LTS Therapy Systems, LLC (2182681)
- Roles
- Manufacturer
- First device listed
- October 14, 2009
- Registered through
- 2026
- Brand names listed
- Iontopatch 80; Iontopatch STAT, Iontopatch Extra Strength
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Device, Iontophoresis, Other Uses | EGJ | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| February 1, 2000 | K992708 | IONTOPATCH | EGJ | Substantially Equivalent | Birch Point Medical, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| May 22, 2025 | 97146 | Class II | Ongoing | IontoPatch STAT, On-the-Go Patch Therapy, Model/Catalog Number D-0062-080; IontoPatch is an Iontophoresis transdermal patch. | The nonwoven pads in the device do not absorb the saline solution or any other liquid intended to be used with the device. | accessdata.fda.gov |
| November 10, 2021 | 89161 | Class III | Terminated | 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. | The dosage information on the pouch is incorrect; the primary carton label is correct. | accessdata.fda.gov |
Compare with other makers
Updated July 29, 2025. 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.