Liberty Multi-Mode Stimulator

United States

Model LMS 1000 · LIBERTY MEDICAL SOLUTIONS, LLC

The Liberty Medical Solutions, LLC Multi-Mode Stimulator (MMS) (the Device) is a battery powered electrotherapy device intended for clinic and outpatient rehabilitative therapy, acute postoperative care and home use for patients suffering from a variety of chronic pain issues. Prescribed by a physician, it gives the clinician a variety of electrotherapy modes to treat a range of indications. The MMS is designed for clinician and patient ease of use and provides safe and effective dispensing of the desired electrotherapy treatment. The Intended Use Environment is Home Healthcare but the Device can also be used in a Chiropractic, Physical Therapy or Pain Management Clinic. The Device uses a tactile button user interface for control of the operating system and therapy amplitude settings. The Device has a liquid crystal character display which provides information to the user and displays the current therapy settings. The Device’s therapeutic output is transmitted through the patient lead wires to the cutaneous hydrogel electrodes affixed to the user’s skin. The energy generated by the Device is conveyed, via the patient lead wires and cutaneous electrodes, through the patients skin to excite either the underlying motor nerves to elicit involuntary muscle contractions or the sensory nerves to manage pain.

DI: 00860000178303
Device class: Class II
Product codes
Submissions: K093138

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Adverse-event reports (MAUDE)

Read this first: MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line shows reporting volume for the average device in the same FDA product code — a reporting baseline, not a risk measure.

No adverse-event reports are linked to this device.

Recall history

Initiated	Recall #	Class	Status	Reason	Quantity	Link basis
2023-11-03	Z-0506-2024	Class II	Open, Classified	The instruction manuals that were included with the Multi-Mode Stimulators distributed from 2018 to 2023 did not contain all of the appropriate warnings and contraindications.Distribution: US Nationwide distribution in the states of CT, FL, NC, NJ, NY.	473 units	code info di

Regulatory clearances

510(k)K093138Substantially equivalent (SESE) · 2010-02-12clearance family

Predicate lineage

K093138
- K070612
- K071137

Cited as predicate by: K113010, K120054, K171978

Lineage each submission cites, walked transitively (indented = the cited device's own predicates). Extracted from public 510(k) summary text — heuristic, and includes reference devices mentioned alongside true predicates.

Manufacturer compliance record

Date	Type	Outcome	Facility	Citations
2026-06-04	VAI	Voluntary action indicated	Liberty Medical Solutions, LLC	1
2026-06-04	VAI	Voluntary action indicated	Liberty Medical Solutions, LLC	1
2023-08-23	NAI	No action indicated	Liberty Medical Solutions, LLC	0
2023-08-23	NAI	No action indicated	Liberty Medical Solutions, LLC	0
2018-06-11	NAI	No action indicated	Liberty Medical Solutions, LLC	0
2018-06-11	NAI	No action indicated	Liberty Medical Solutions, LLC	0

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