Livia Neurology Device NUH

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK183110	Date4 May 2020Cleared	StatusActive

Official records

FDA 510(k) database 510(k) number K183110

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number: K183110
FDA product code: NUH
FDA applicant: Lifecare , Ltd.

Device class: Class II
Regulation: 21 CFR Part 882.5890
Advisory committee: Neurology
FDA decision: SESE Substantially Equivalent

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Livia K163153 28 Jun 2017 FDA record · FDA summary

Cited by

Well-Life Pain Relief (Menstrual Plus) Electrical Stimulator; TENS/EMS WITH Menstrual Relief Stimulator; Well-Life Pain Relief Stimulator; Menstrual Plus Stimulator K233054 18 Oct 2024 FDA record · FDA summary
Ova+ (K-OVAP-USA) K230926 15 Dec 2023 FDA record · FDA summary
Wireless TENS/EMS, Bruno, Aela K220997 1 Sep 2022 FDA record · FDA summary

Source: 510k-lineage (choiben314), CC BY 4.0

Overview

AI-generated summary, 21 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

Livia is a Class 2 Neurology device with product code NUH. It is substantially equivalent to predicate devices in principles of operation, technology, materials, and indications for use.

Livia was cleared by the FDA through the Traditional 510(k) pathway under K183110, following a 543-day review. The device is manufactured by Lifecare, Ltd., located in Tiberias, Israel.

Similar devices

Other devices filed under FDA product code NUH (Stimulator, Nerve, Transcutaneous, Over-The-Counter).

Other devices from Lifecare, Ltd.

Lifecare Compact Tens Device

Class II
Livia

Class II