LTS Therapy Systems, LLC

West St Paul, MN, US

LTS Therapy Systems, LLC appears in FDA device records in West St Paul, MN. FDA records list one 510(k) clearance, no PMA records and one registered establishment. As of 2026-09-10, FDA records show 3 recalls for this company, and at least one establishment registration is current.

510(k) clearances: 1
PMA records: 0
Recall records: 3
Registered establishments: 1

FDA records under these names

1 name

FDA records resolved to LTS Therapy Systems, LLC carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.

Tapemark Co.510(k), enforcement report, recall

510(k) clearance history

FDA records hold 1 510(k) clearance for LTS Therapy Systems, LLC in 1984.

Clearances by year, as a table

510(k) clearance decisions for LTS Therapy Systems, LLC, by decision year
Year	Clearances
1984	1

510(k) clearances on record, most recent first
K number	Device	Product code	Decision	Decision date
K841487	INTRAVASCULAR CATHETER SECUREMENT DEV	KMK	Substantially Equivalent	1984-06-28

Registered establishments

FDA registered establishments for LTS Therapy Systems, LLC, with the product codes listed at each
Registration	FEI	Establishment	Address	Registration expires	Product codes listed
2182681	2182681	LTS Therapy Systems, LLC	1685 MARTHALER LN., West St Paul, MN 55118 US	2026	EGJ

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
Recall	Product	Reason	Classification	Initiated	Status
Z-2197-2025	IontoPatch 80, On-the-Go Patch Therapy, Model/Catalog Number: D-0077-080; The 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.	Class II	2025-05-22	Open, Classified
Z-2196-2025	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.	Class II	2025-05-22	Open, Classified
Z-0454-2022	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.	Class III	2021-11-10	Terminated

Verification record

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Data as of 2026-09-28, FDA export datePage updated 2026-09-05Source: openFDA, public domain