Cleared Traditional

LIVIA (K183110) - FDA 510(k) Clearance

Class II Neurology device cleared through predicate-based substantial equivalence.

K183110 · Lifecare , Ltd. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2020
Decision
543d
Days
Class 2
Risk

K183110 is an FDA 510(k) clearance for the LIVIA. Classified as Stimulator, Nerve, Transcutaneous, Over-the-counter (product code NUH), Class II - Special Controls.

Submitted by Lifecare , Ltd. (Tiberias, IL). The FDA issued a Cleared decision on May 4, 2020 after a review of 543 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5890 - the FDA neurology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Neurology submissions.

View all Lifecare , Ltd. devices

Submission Details

510(k) Number K183110 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 08, 2018
Decision Date May 04, 2020
Days to Decision 543 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
395d slower than avg
Panel avg: 148d · This submission: 543d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code NUH Stimulator, Nerve, Transcutaneous, Over-the-counter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5890
Definition Temporary Relief Of Pain Due To Sore/aching Muscles
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Neurology devices follow this clearance model.

Regulatory Consultant

Cohen, Tauber, Spievack & Wagner
Irving L. Wiesen

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Clinical Evidence

ClinicalTrials.gov
NCT03064945 Completed Interventional Industry-sponsored

The Effectiveness and Safety of LIVIA® Transcutaneous Electrical Nerve Stimulation (TENS) in Women Suffering From Primary Dysmenorrhea.

A Randomized, Controlled, Multi-Center, CROSSOVER, Prospective, Double-blind Clinical Study to Assess the Effectiveness and Safety of Livia® Transcutaneous Electrical Nerve Stimulation (TENS) in Women Suffering From Primary Dysmenorrhea

63
Patients (actual)
1
Site
Treatment
Purpose
Quadruple
Masking
Condition studied Dysmenorrhea
Study design Crossover
Eligibility Female only · 18 Years+
Sponsor iPulse Medical Ltd. (Livia) (industry)
Started 2017-06-01 → Primary completion 2018-04-25
Primary outcome
The difference between the reported Visual Analogue Scale before and after applying the device (active or sham).
Secondary outcome
Usage of pain relievers during the menstrual period
Study completed - no results published. This trial concluded in 2018 but has not posted results to ClinicalTrials.gov. Completed studies without public results are common in industry-sponsored device trials; the data may be referenced in the 510(k) Summary PDF or remain unpublished.
View full study on ClinicalTrials.gov

Regulatory Peers - NUH Stimulator, Nerve, Transcutaneous, Over-the-counter

All 226
Devices cleared under the same product code (NUH) and FDA review panel - the closest regulatory comparables to K183110.
TENS/EMS device (GUSE01)
K253896 · Globalcare Medical Technology Co., Ltd. · Mar 2026
TENS AND EMS (TENS and Muscle Stimulator) (JT1065, JT1080, JT2080, JT9034)
K253305 · Shenzhen Jiantuo Electronics Co., Ltd. · Dec 2025
VEINOPLUS Back
K251958 · Dynapulse Medical · Dec 2025
TENS&EMS (HZ9151B, HZ9151C, HZ9151D)
K253740 · Hong Qiangxing (Shenzhen) Electronics Limited · Dec 2025
Transcutaneous Electrical Nerve Stimulator (RJTENS-2)
K252688 · Bozhou Rongjian Medical Appliance Co., Ltd. · Nov 2025
Li-Battery Powered OTC TENS/EMS Combination Stimulator, Model Z4
K251856 · Everyway Medical Instruments Co.,Ltd · Nov 2025