RegWardenFDA facility compliance records
Facility

LTS Therapy Systems, LLC

1 recall(s) on record — most severe on record: Class II.

Activity by year

FDA actions on record by year2019: 1 inspections; 2023: 1 inspections; 2025: 1 recalls2017201812019202020212022120232024120252026
  • Recalls (1)
  • Inspections (2)

Devices registered here (1)

  • Device, Iontophoresis, Other Uses
    Product code EGJ (opens in a new tab) · Class II · Physical Medicine · 21 CFR 890.5525

Recalls & enforcement

  • Class IIOngoing2025-05-22
    The nonwoven pads in the device do not absorb the saline solution or any other liquid intended to be used with the device.

FDA inspections (2)

  • NAI2023-09-20
    No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices
  • NAI2019-03-28
    No Action Indicated · Compliance: Devices

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

Related

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “LTS Therapy Systems, LLC (FEI 2182681) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/2182681-lts-therapy-systems-llc/

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