LTS Therapy Systems, LLC

FDA Regulatory Profile

LTS Therapy Systems, LLC appears in FDA public data with 2 recalls, 0 510(k) clearances, 10 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-2197-2025, Class II) was initiated on May 22, 2025.

Summary

Total Recalls
2
510(k) Clearances
0
Inspections
10
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-2197-2025Class IIIontoPatch 80, On-the-Go Patch Therapy, Model/Catalog Number: D-0077-080; The IontoPatch is an IonMay 22, 2025
Z-2196-2025Class IIIontoPatch STAT, On-the-Go Patch Therapy, Model/Catalog Number D-0062-080; IontoPatch is an IontophoMay 22, 2025