The Livia is designed for symptomatic relief and management of chronic intractable pain, and for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities (arm) and lower (extremities) leg due to strain from exercise or normal household work activities. It should be applied to normal, healthy, dry and clean skin of adult patients, and is to be used for stimulate healthy muscles in order to improve and facilitate muscle performance.

Device Description

The LIVIA is a TENS device. TENS is an acronym for Transcutaneous Electrical Nerve Stimulator, and it works as a pain treatment system through electrotherapy. The unit sends light electrical pulses into the body through the skin by the use of electrodes. which are placed over peripheral nerves. The TENS unit works by sending high frequency electrical signals that are both continuous and mild to block out those pain signals that are being delivered to the brain. The Livia device was designed with specific pulse frequency and pulse length that are suitable for its intended use. When these pain signals are halted, pain isn't felt by the reactive area and the patiernt get relief. Low frequency bursts of mild electrotherapy also help the natural pain control response to activate, and these beta endorphins ease the pain that are being felt by the patient.

AI/ML Overview

The provided text is a 510(k) summary for the device "Livia." It outlines the device's indications for use, its comparison to predicate devices, and the non-clinical tests performed to demonstrate substantial equivalence. However, it explicitly states in Section 9: "Discussion of Clinical Tests Performed: Livia Inc. determined that bench and non clinical testing were sufficient to demonstrate that the LIVIA device is as safe and effective as the predicate devices."

This directly indicates that no clinical study was performed or required for the Livia device to obtain 510(k) clearance based on substantial equivalence to existing predicate devices. Therefore, I cannot provide details on acceptance criteria or a study that proves the device meets those criteria, as such a study was not conducted or submitted for this specific 510(k) clearance.

The document primarily focuses on demonstrating that the Livia device has similar technological characteristics and performs comparably to the predicate devices (Philips Consumer Lifestyle PulseRelief (K151035) and NeuroMetrix ASCEND (K10433)), and that non-clinical testing was deemed sufficient by the manufacturer and accepted by the FDA for this substantial equivalence determination.

Summary

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, resembling a bird-like shape.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

June 28, 2017

Lifecare Ltd. % Irving Wiesen Official Correspondent Cohen, Tauber, Spievack & Wagner 420 Lexington Avenue-suite 2400 New York, New York 10170

Re: K163153

Trade/Device Name: Livia Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator For Pain Relief Regulatory Class: Class II Product Code: NUH Dated: May 25, 2017 Received: May 30, 2017

Dear Irving Wiesen:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

{1}------------------------------------------------

the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

William J. Heetderks -S 2017.06.28 15:57:47 -04'00'

for Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K163153

Device Name Livia

Indications for Use (Describe)

It should be applied to normal, healthy, dry and clean skin of adult patients, and is to be used for stimulate healthy muscles in order to improve and facilitate muscle performance

Type of Use (Select one or both, as applicable)
-------------------------------------------------

☐ Prescription Use (Part 21 CFR 801 Subpart D)
☑ Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

Section 5: 510(K) SUMMARY

The assigned 510(K) Number: K163153

1. Submitter's Identification:

LifeCare Ltd.

Zipori St.2 1424602, Tiberias, Israel

Date Summary Prepared: May 25, 2017

Contact Person: Irving L. Wiesen, Esq. Law Offices of Irving L. Wiesen P.C. 420 Lexington Avenue - Suite 2400 New York, New York 10170 Tel 212-381-8774 Fax 646-536-3185 Email: iwiesen@wiesenlaw.com

2. Name of the Device:

Livia

3. Common Name and Classification:

Stimulator, Nerve, Transcutaneous, Over-The-Counter Requlation: 21 CFR Part 882.5890 Product Code: NUH

4. Predicate Device Information:

Primary Predicate: Philips Consumer Lifestyle PulseRelief (K151035) ●
Reference Predicate: NeuroMetrix ASCEND (K10433)

5. Device Description:

{4}------------------------------------------------

6. Indication For Use:

The Livia is designed for symptomatic relief and management of chronic pain, and for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm) and lower (extremities) leg due to strain from exercise or normal household work activities. It should be applied to normal, healthy, dry and clean skin of adult patients, and is to be

used for stimulate healthy muscles in order to improve and facilitate muscle performance.

7. Comparison to Predicate Devices:

The Livia device indications for use and technological characteristics are substantially equivalent to the Philips Consumer Lifestyle PulseRelief device application (K151035).

The primary predicate device is the Philips Consumer Lifestyle PulseRelief device and the reference predicate is NeuroMetrix ASCEND device application (K104333).

TABLE 1: Indication For Use Comparison Table

Parameter	Primary Predicate	Subject Device
	Philips ConsumerLifestyle PulseRelief(K151035)	LIVIA
IndicationFor Use	The OTC TENS/EMSstimulator PulseRelief isdesigned to be used fortemporary relief of painassociated with sore andaching muscles in theshoulder, waist, back,neck, upper extremities(arm) and lowerextremities (leg) due tostrain from exercise ornormal household workactivities. It should beapplied to normal,healthy, dry and cleanskin of adult patients, andis to be used for stimulatehealthy muscles in order	The Livia is designed for symptomatic relief andmanagement of chronic pain, and for temporaryrelief of pain associated with sore and achingmuscles in the shoulder, waist, back, neck, upperextremities (arm) and lower (extremities) leg dueto strain from exercise or normal householdwork activities.It should be applied to normal, healthy, dry andclean skin of adult patients, and is to be used forstimulate healthy muscles in order to improveand facilitate muscle performance.

Comparison Tables - Technological Characteristics

{5}------------------------------------------------

	to improve and facilitatemuscle performance.
Class	II	II
Product Code	NUH; NGX	NUH; NGX
Regulation Number	21 CFR 882.5890(b);21 CFR 890.5850	21 CFR 882.5890(b);21 CFR 890.5850

Table 2: Basic Unit Characteristics Comparison Table

Parameter	Primary PredicatePhilips ConsumerLifestylePulseRelief(K151035)	Livia	SignificantDifferences
510(k) Number	K151035	K163153	N/A
Device Name and Model NumberManufacturer	PulseReliefPhilips ConsumerLifestyle	LIVIALife Care Ltd	N/A
Power Source(s)	3.7V Lithium-ion	3.7V Lithium-ionbattery(rechargeable)	Identical
Method of Line Current Isolation	N/A	Output iselectricallydisabled whenconnect tocharger, bymeans ofmicroprocessorcharging circuit	Similar to thereference predicateNeurometrixdevice cannot be usedwhile battery ischarging
Patient Leakage Current- Normal Condition (μΑ)	Battery powered(< 10μΑ)	Battery powered(< 10μΑ)	Identical
Patient Leakage Current- Single Fault Condition (μΑ)	Battery powered(< 50μΑ)	Battery powered(< 50μΑ)	Identical to Philips
Average DC current throughElectrodes when device is on but nopulsesare being applied (μA)	0 μΑ	0 μΑ	Identical to Philips
Number of Output Modes	15 TENS, 5 EMS	1	Similar to thereference predicateNeurometrix
Number of OutputChannels:	Synchronous orAlternatingMethod of Channel	1N/A	1N/A	Identical

{6}------------------------------------------------

	Isolation
Regulated Current or Regulated		Current	Current	Identical
Voltage
Software/Firmware/MicroprocessorControl?		Yes	Yes	Identical
Automatic Overload Trip		Yes	Yes	Identical
Automatic No-Load Trip		Yes	Yes	Identical
Automatic Shut Off		Yes	No
User Override Control		Yes	Yes	Identical
IndicatorDisplay:	On/Off Status	Yes	Yes	Identical
	Low Battery	Yes	Yes	Identical
	Voltage/CurrentLevel	Yes	Yes	Identical to Philip
Timer Range (minutes)		1-59 minutes		The Livia has nointeral timer, a minordifference, as there isno treatment timelimitation for using theLivia-see Instructionsfor Use.
Compliance with VoluntaryStandards?		IEC 60601-1, IEC60601-1-2, IEC60601-2-10, ISO10993-5 and -10	IEC 60601-1,IEC 60601-1-2IEC 60601-1-11IEC 60601-2-10,ISO 10993-5 and -10	Identical
Compliance with 21 CFR 898?		Yes	Yes	Identical
Weight (g)		62 g	36 g	None, all devices areof hand-held weight
Dimensions (mm) (W x H x D)		2 units, each54 x 54 x14	55 x 55 x 18	None, all devices areof hand-held size
Housing Materials andConstruction		PC/ABS plastic	PC/ABS plastic	Identical

Table 3: Output Specification for TENS Mode Comparison Table

Parameter	Primary PredicatePhilips ConsumerLifestylePulseRelief(K151035)	Livia	SignificantDifferences
Waveform (e.g., pulsed	Biphasic,Symmetrical	Biphasic,Symmetrical	Identical
monophasic,
biphasic)
Shape (e.g., rectangular, spike)	Rectangular	Rectangular	Identical
Maximum Output Voltage	50V @ 500Ω	50V @ 500Ω	Identical to the reference
(volts)			predicate NeuroMetrix
(+/-10%)	100V @ 2kΩ	64V @ 2kΩ	Similar to both devices and within
				their range
		100V @ 10kΩ	64V @ 2kΩ	Similar; the maximum outputvoltage of the Livia, althoughslightly lower than the predicates,provides the required intensity foran effective treatment with lowerrisk of discomfort to the user dueto high voltage
Maximum Output Current(mA)(+/-10%)		100mA @ 500Ω	50 mA @ 500Ω	Similar to both devices and withintheir rangeThe Livia was designed to supplythe minimum required output forproviding an effective treatment.This in fact lowers the risk to thepatient
		50mA @ 2kΩ	31mA @ 2kΩ	The Livia was designed to supplythe minimum required output forproviding an effective treatment.This in fact lowers the risk to thepatient
		10mA @ 10kΩ	6.4mA @ 10kΩ	The Livia was designed to supplythe minimum required output forproviding an effective treatment.This in fact lowers the risk to thepatient
Duration of primary(depolarizing)phase (usec)		100 µs	100 µs	Same as the reference predicateNeuroMetrix
Pulse Duration (both phases)(usec)		200µs, additional30µsinter-phase delay	100 µs	Similar, within the range of thepredicate devices
Frequency (Hz)		Random, mean80Hz,uniformdistribution60-100Hz	100 Hz	Identical to PulseRelief
Formultiphasicwaveformsonly:	SymmetricalphasesPhaseDuration(include units),(state range, ifapplicable),(both phases,ifasymmetrical)	Yes	Yes	Identical
		100µs (eachphase)	100 µs	Identical to the referencepredicate NeuroMetrix
Net Charge (microcoulombs(µC)		Nominally 0uC@ 500Ω	0uC@ 500Ω	Identical to PulseRelief
per pulse) (If zero, state howthiswas achieved)	zero net current
Maximum Phase Charge, (µC)	10 µC @500Ω	6.4 µC @500Ω	Similar and within the range ofPulseRelief
Maximum Current Density,(mA/cm2, r.m.s.)	0.51 mA/cm2@ 500Ω	0.38mA/cm2@500Ω	The minor differences areresulting from the minor specdifference as well as thedifference in electrode area.
Maximum Average Current(average absolute value), mA	1.6 mA @ 500Ω	1.19 mA @500Ω	Similar PulseRelief
Maximum Average PowerDensity,(W/cm2), (using smallestconductivesurface area)	3.6 mW/cm2 @500Ω	2.05mW/cm2@500Ω	Similar PulseRelief
NBurstMode;(i.e., pulsetrains)	(a) Pulses perN/A	N/A	N/A	N/A
	(b) Bursts persecond	N/A	N/A	N/A
	(c) Burstduration(seconds)	N/A	N/A	N/A
	(d) Duty Cycle:Line (b) x Line(c)	N/A	N/A	N/A

{7}------------------------------------------------

{8}------------------------------------------------

The candidate device is similar or very close to the predicate devices in its all major claims. The minor differences between predicate and candidate device do not affect the safety and effectiveness.

8. Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence are as follows:

Non-clinical verification testing of the LIVIA device included electrical, mechanical, and software tests to show the device meets its design specifications. Validation and performance testing validates that the device meets its user needs. Verification and validation test results established that the device meets its intended use, that it is as safe, as effective, and performs as well as the predicate devices, and that no new issues of safety and effectiveness were raised. The LIVIA device was designed, verified, and validated according to the company's Design Control process and has been

{9}------------------------------------------------

subjected to extensive safety and performance testing as shown in the test results provided in this submission. Verification and Validation testing data demonstrate that the device meets all of its specifications including compliance with the following standards:

Safety :

IEC 60601-1:2005/A1:202, EN 60601-1:2006/A1:2013
EN 60601-2-10:2012/A1:2012
IEC 60601-1-11:2015

EMC:

IEC 60601-1-2:2007

Software:

IEC 62304:2006
Biocompatibility:
ロ ISO 10993-5:2009
ISO 10993-10:2010

Usability Study:

ロ IEC 62366-1: 2015
The Livia device and its accompanying documentation, i.e., the IFU have met all usability specifications that were defined. No user errors or near errors were observed.

9. Discussion of Clinical Tests Performed:

Livia Inc. determined that bench and non clinical testing were sufficient to demonstrate that the LIVIA device is as safe and effective as the predicate devices.

10. Conclusions:

Livia is substantially equivalent in its intended use, performance, safety, effectiveness and underlying scientific and operating principal used, to the predicate devices.

Regulation Number and Section

§ 882.5890 Transcutaneous electrical nerve stimulator for pain relief.

(a)
Identification. A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain.(b)
Classification. Class II (performance standards).