TENS stands for Transcutaneous Electrical Nerve Stimulation. Unipro TENS is used to provide symptomatic pain relief for chronic, acute or post-operative pain.

EMS stands for Electrical Neuromuscular Stimulation. Unipro EMS is indicated for:

· Relaxation of muscle spasm
· Increasing local blood circulation and muscle re-education
· Prevention or retardation of disuse atrophy
· Prevention of venous thrombosis of the calf muscles immediately after surgery
· Maintaining on increasing range of motion

MIC stands for Microcurrent Stimulation. Unipro MIC is used to provide sumptomatic pain relief for chronic intractable pain, post traumatic pain or post surgical pain.

IFT stands for Interferntial Stimulation. Unipro IFT is indicated for symptomatic relief of chronic intractable pain.

Device Description

Unipro is a non-invasive, non-sterile, reusable medical device which is intended to be used in both the hospital and home healthcare environment. It is a microprocessor controlled, non-implantable, portable neuromuscular electrical stimulator which is powered by a built in Li-ion rechargeable battery.

Unipro is a multitherapy unit that combines the treatment capabilities of TENS (Transcutaneous Electrical Nerve Stimulation), EMS (Electrical Muscle Stimulation), MIC (Microcurrent Stimulation) and IFT (Interferential Therapy). The mode selection button on device will enable the user to switch between different modes (TENS, EMS II, EMS III, or massage). Each time the user changes the mode or program, the intensity level will revert to zero. This is a safety feature to alleviate any sudden feeling of a surge, as each program gives a different sensation.

Unipro Case L (large) features a white ABS case with a white silicone button pad and white power button. Power button is located on the right-hand side of the device. The hardware features a black perimeter border and black LCD display. Charging cable and lead inserts are located on the bottom of the device.

Unipro is supplied with self-adhesive electrodes which attach to the control unit via lead wires. A gentle electrical current is sent to underlying nerves and muscle groups via these electrodes applied on the skin to relieve pain. Placement of the electrode pads of the device depends on the selected device mode (TENS, EMS, IFT2, IFT4, MIC). For TENS, the easiest way is to apply the electrode pads around/near the source of the pain. For EMS, place two electrode pads over the bulk of the muscle, with one electrode over the muscle's motor point. For IFT2, electrodes should be placed either side of the area of pain and for IFT4, the pads need to apply in positions so that the signals from each channel cross over the point to be treated. Finally, for MIC, the electrode pads should be placed in such a way that a straight line between them passes through the problem area.

AI/ML Overview

The TensCare Ltd Unipro (K232441) is a multi-therapy electrical stimulator combining TENS, EMS, MIC, and IFT functionalities. The submission claims substantial equivalence to the predicate device, Ultima NEO (K120054).

Here's a breakdown of the requested information based on the provided text:

1. A table of acceptance criteria and the reported device performance

The provided documentation does not explicitly list "acceptance criteria" for performance metrics in a pass/fail format. Instead, it compares the technical characteristics and indications for use of the Unipro to its predicate device, Ultima NEO, to demonstrate substantial equivalence. The "Comparison" column in the tables serves as a qualitative assessment of whether the Unipro's performance characteristics are similar enough to the predicate.

Characteristic	Acceptance Criteria (Implied: Similar to Predicate)	Reported Device Performance (Unipro)	Comparison
Indications for Use	Identical to Ultima NEO	TENS, EMS, MIC, IFT for pain relief and muscle stimulation (detailed in text)	Identical
Intended Population	Similar to Ultima NEO (Male and female patients over 18)	Male and female patients over 21	Substantially Equivalent (difference in age: 21 vs 18)
Power Source	Similar to Ultima NEO (Li-ion rechargeable battery)	3.7V 1500mAh Lithium-ion battery (rechargeable)	No substantial difference
Average DC current through Electrodes (no pulses)	0 µA	0 µA	Identical
Number of Output Modes	4 (TENS, EMS, MIC, IFT)	4	Identical
Number of programs/modes	Similar to Ultima NEO (41 programs)	76	No substantial difference (Both comply with IEC 60601-1)
Number of Output Channels	2	2	Identical
Timer Range	Similar to Ultima NEO (10-90 minutes, constant)	5-90 minutes, constant	No substantial difference (Unipro can be set lower)
Regulated Current or Voltage?	Current and Voltage	Current and Voltage	Identical
Software/Firmware/Microprocessor Control?	Yes	Yes	Identical
Automatic No-Load Trip?	Not publicly available for predicate (implied: similar/present)	Yes (TENS/EMS)	-
Automatic Overload Trip?	Not publicly available for predicate (implied: similar/present)	No	-
Automatic Shut Off?	Not publicly available for predicate (implied: similar/present)	Yes	-
User Override Control?	Not publicly available for predicate (implied: similar/present)	Yes	-
Indicator Display	On/Off, Low battery, Voltage/Current level, Time to cut-off	Yes for all	Identical
Compliance Voluntary Standards	IEC 60601-1, IEC 60601-1-2, IEC 60601-2-10, etc.	IEC 60601-1, IEC 60601-1-2, IEC 60601-2-10, etc.	Substantial equivalent
Compliance with 21 CFR regulations	Yes	Yes	Identical
Dimensions	Similar to Ultima NEO (123 x 61 x 22mm)	125mm x 62mm x 29.6mm	Different, but does not affect safety/effectiveness
Weight	Similar to Ultima NEO (160g)	128.5g	Different, but does not affect safety/effectiveness
Housing Materials	ABS 757 material	ABS 757 material	Identical
Sterilization	N/A	N/A	Identical
Waveform (TENS/EMS)	Bi-phase Symmetrical Rectangular, Asymmetrical Rectangular, Mono-Phase Symmetrical Rectangular (predicate)	TENS/EMS: Symmetrical Rectangular	No substantial difference
Waveform (Microcurrent)	Symmetrical Rectangular (predicate)	Continuous square unipolar, sawtooth unipolar, symmetrical balanced wave	No substantial difference (Both comply with IEC 60601-1)
Waveform (IFT)	Symmetrical balanced sine wave	Symmetrical balanced wave	Identical
Maximum Output Voltage (TENS/EMS)	73.6V@500Ω, 120V@2 kΩ, 124V@10 kΩ (predicate)	54V@500Ω, 114 V@2 kΩ, 116 V@10 kΩ	No substantial difference (lower, but proportional to current, complies with IEC 60601-1)
Maximum Output Voltage (Microcurrent)	0.54V@500Ω, 2.12V@2 kΩ, 10.2V@10 kΩ (predicate)	0.4V@500Ω, 1.56 V@2 kΩ, 7.8 V@10 kΩ	No substantial difference (lower, but proportional to current, complies with IEC 60601-1)
Maximum Output Voltage (IFT)	17V@500Ω, 30V@2 kΩ, 32 V@10 kΩ (predicate)	24V@500Ω, 34.4 V@2 kΩ, 40 V@10 kΩ	No substantial difference (complies with IEC 60601-1)
Maximum Output Current (TENS/EMS)	147mA@500Ω, 60mA@2 kΩ, 12.4mA@10kΩ (predicate)	108mA@500Ω (200μs), 80mA @500Ω (400μs), 57mA@2 kΩ, 11.6 mA@10 kΩ	No substantial difference (Unipro features amplitude modulation mode)
Maximum Output Current (Microcurrent)	1.08mA, 1.06mA, 1.02mA (predicate)	0.8mA, 0.78 mA @2 kΩ, 0.78 mA @10 kΩ	No substantial difference (Unipro MIC amplitude smaller, complies with IEC 60601-1)
Maximum Output Current (IFT)	34mA@500Ω, 15mA@2 kΩ, 3.2mA@10kΩ (predicate)	48mA@500Ω, 17.2mA@2 kΩ, 4mA@10 kΩ	No substantial difference (complies with IEC 60601-1)
Pulse Width (TENS/EMS)	50-400µs (predicate)	TENS: 50-300 µs, EMS: 100-400 µs	No substantial difference (within recommended output, complies with IEC 60601-2-10)
Pulse Width (Microcurrent)	2-200ms (predicate)	10-200ms	No substantial difference (within recommended output, complies with IEC 60601-2-10)
Pulse Width (IFT)	120-125µs (predicate)	125 µs	No substantial difference (within recommended output, complies with IEC 60601-2-10)
Frequency (TENS/EMS)	1-150Hz (predicate)	TENS: 2-150Hz, EMS: 10-120Hz	No substantial difference (Unipro's range is within recommended range, complies with IEC 60601-2-10)
Frequency (Microcurrent)	1-150Hz (predicate)	0.5Hz, 1Hz, 1.5Hz, 2Hz, 3Hz, 4Hz, 5Hz to 50Hz	No substantial difference (within recommended range, complies with IEC 60601-2-10)
Frequency (IFT)	4000-4160Hz (predicate)	2-160Hz (Carrier Frequency: 4000Hz fixed (CH1))	No substantial difference (Predicate's higher frequency may not offer additional benefit, complies with IEC 60601-2-10)
Net Charge (µC per pulse)	0.4µC@ 500 Ω (predicate)	0.3µC@ 500 Ω	No substantial difference (Charge output dependent on current, complies with IEC 60601-1)
Maximum Phase Charge (µC)	TENS/EMS: 21.62μC@500Ω, Microcurrent: 220.8μC@500Ω, IFT: 5.16μC@500Ω (predicate)	TENS/ EMS: 22.76μC@500Ω, Microcurrent: 160μC@500Ω, IFT: 2.8μC@500Ω	No substantial difference (Charge used to set pulse width, complies with IEC 60601-1)
Maximum Current Density (mA/cm²)	TENS/EMS: 5.88mA/cm²@500Ω, Microcurrent: 0.022mA/cm²@500Ω, IFT: 1.65mA/cm²@500Ω (predicate)	TENS/EMS: 0.8mA/cm²@500Ω, Microcurrent: 0.008mA/cm²@500Ω, IFT: 0.82mA/cm²@500Ω	No substantial difference (both comply with IEC 60601-1)
Maximum Power Density (W/cm²)	TENS/EMS: 0.0086W/cm², Microcurrent: 0.012W/cm², IFT (predicate)	TENS/ EMS: 0.0076 W/cm2, Microcurrent: 0.0001049 W/cm2, IFT	No substantial difference (both comply with IEC 60601-1)

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The submission indicates that "No clinical testing was considered necessary." Therefore, there is no sample size for a new test set or details on data provenance from a prospective or retrospective study involving the Unipro device. The equivalence claim is based on comparison to the predicate and literature review.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable, as no clinical testing was performed on the device to establish a new ground truth. The basis of the submission relies on the established safety and effectiveness of the predicate device and the modes of therapy.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable, as no clinical testing was performed that would require adjudication of a test set.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is not an AI-assisted diagnostic or interpretative tool, and no MRMC study was conducted.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable. This device is a direct-use electrical stimulator, not an algorithm. Its performance is evaluated through bench testing against established standards and comparison to a predicate device.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

The "ground truth" for the Unipro's substantial equivalence claim is based on the established safety and effectiveness of the legally marketed predicate device (Ultima NEO), and recognized international consensus standards (e.g., IEC 60601-1, IEC 60601-2-10). Additionally, it mentions a formal review of published research and clinical evaluation on the use of TENS, EMS, IFT, and MC for pain relief and muscle training, which serves as a form of expert consensus and outcomes data from the broader scientific community.

8. The sample size for the training set

Not applicable, as this is not an AI/machine learning device that requires a training set.

9. How the ground truth for the training set was established

Not applicable, as this is not an AI/machine learning device that requires a training set.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

August 30, 2024

TensCare Ltd Saskia Eldridge-Hinmers Ouality Assurance & Regulatory Affairs Executive 9 Blenheim Road Epsom, Surrey KT19 9BE United Kingdom

Re: K232441 Trade/Device Name: Unipro (K-UNIPRO-US) Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator For Pain Relief Regulatory Class: Class II Product Code: GZJ, IPF, LIH Dated: August 28, 2024 Received: August 28, 2024

Dear Saskia Eldridge-Hinmers:

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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Heather L. Dean -S

for Pamela Scott

Assistant Director, Neuromodulation - Psychiatry Devices DHT5B: Division of Neuromodulation and Rehabilitation Devices OHT5: Office of Neurological and Physical Medicine Devices

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Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

Submission Number (if known)

K232441

Device Name

Unipro (K-UNIPRO-US)

Indications for Use (Describe)

TENS stands for Transcutaneous Electrical Nerve Stimulation. Unipro TENS is used to provide symptomatic pain relief for chronic, acute or post-operative pain.

EMS stands for Electrical Neuromuscular Stimulation. Unipro EMS is indicated for:

· Relaxation of muscle spasm
· Increasing local blood circulation and muscle re-education
· Prevention or retardation of disuse atrophy
· Prevention of venous thrombosis of the calf muscles immediately after surgery
· Maintaining on increasing range of motion

MIC stands for Microcurrent Stimulation. Unipro MIC is used to provide sumptomatic pain relief for chronic intractable pain, post traumatic pain or post surgical pain.

IFT stands for Interferntial Stimulation. Unipro IFT is indicated for symptomatic relief of chronic intractable pain.

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)

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TensCare LTD. 9 Blenheim Road Epsom, Surrey, KT19 9BE United Kingdom

5. 510(k) SUMMARY - K232441

5.1. Submitters Identification

Submitter:	TensCare Ltd
Address:	9 Blenheim Road, Epsom,Surrey, KT19 9BE, United Kingdom
Tel:	+44(0)1372 723 434
Fax:	+44(0)1372 745 434
FDA Establishment Registration No:	3003446042

Contact person:	Saskia Eldridge-Hinmers
	Regulatory Affairs Associate
Contact Phone:	+44(0)7879424785
Contact Email:	Saskia.Eldridge-Hinmers@tenscare.co.uk
Date Prepared:	20.March. 2024

Address of the manufacturing facility:

EasyMed Instruments Co Ltd 3/F, 5F/6F, Block A, Gupo Gongmao Building, Fengxin Road, Fengxiang Industrial District, Daliang, 528300 Shunde, Foshan, Guangdong, China,

FDA Establishment Registration No: 3004049909

Address of American Representative:

Contact First Name,	SCOTT A
Contact Last Name:	BEDNAR
Title:	MR
Business Name:	QA/RA CONSULTING GROUP, INC.
Full Address:	3335 TUSCARAWAS ROADBEAVER, PENNSYLVANIA, 15009, UNITED STATES
E-mail:	sbednar@qaraconsultinggroup.com
Phone Number:	412 -4188066

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5.2. Subject Device

Manufacturer	: Tenscare Limited
Trade/Device Name	: Unipro (K-UNIPRO-USA)
510(k) Number	: K232441
Device Classification Name	: Stimulator, Nerve, Transcutaneous, for pain relief
Common Name:	: For the TENS/MIC system-TENS deviceFor the EMS system-Powered Muscle StimulatorsFor the IF system-interferential Stimulator
Classification Name	: For TENS / MIC systemStimulator, Nerve, Transcutaneous, for Pain Relief - GZJFor EMS systemPowered Muscle Stimulator - IPFFor IF systemInterferential current therapy - LIH
CFR Regulation Number	: 21 CFR 882.5890 and 21 CFR 890.5850
Product Code	: GZJ, IPF, LIH
FDA Device Classification	: Class II

Predicate Devices 5.3.

5.3.1. Predicate Device

Manufacturer	: EasyMed Instruments Co., Ltd
Trade/Device Name	: Ultima NEO
510(k) Number	: K120054
Device Classification Name	: Stimulator, Nerve, Transcutaneous, for pain relief
Regulation Description	: Transcutaneous Electrical Nerve Stimulator for Pain Relief
CFR Regulation Number	: 21 CFR 882.5890 and 21 CFR 890.5850
Product Code	: GZJ, IPF, LIH
FDA Device Classification	: Class II
Device Type ID	: 3755

5.4. Device Description

Tenscare Ltd., Traditional 510(k) Unipro

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program, the intensity level will revert to zero. This is a safety feature to alleviate any sudden feeling of a surge, as each program gives a different sensation.

The subject device has no fixed shelf life. The machine will often last for more than 5 years but is warrantied for 2 years. As it is an electronic device, it must not be disposed of as general, domestic waste and must comply with FDA regulation and environmental protection rules for safe disposal of electronic waste.

An unopened pack of electrode pads is intended to last up to two years, which may vary following exposure to low humidity or high temperatures. Once used, the electrode pads are expected to last 12-20 applications, depending on skin condition and humidity. The electrode pads can then be disposed of as standard domestic waste. The subject device and associated accessories are supplied non-sterile.

Indication For Use/Intended Use 5.5.

TENS stands for Transcutaneous Electrical Nerve Stimulation. The Unipro TENS system is used to provide symptomatic pain relief for chronic, acute or post-operative pain.

EMS stands for Electrical Neuromuscular Stimulator. The Unipro EMS system is indicated for:

. Relaxation of muscle spasm
. Increasing local blood circulation and muscle re-education
. Prevention or retardation of disuse atrophy
Prevention of venous thrombosis of the calf muscles immediately after surgery
. Maintaining or increasing range of motion.

MIC stands for Microcurrent Stimulation. -The Unipro MIC system is used to provide symptomatic pain

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relief for chronic intractable pain, post traumatic pain or post-surgical pain. IF stands for Interferential Stimulation. The Unipro system is indicated for:

Symptomatic relief of chronic intractable pain. ●

5.6. Indication for Use comparison

TABLE 1: Indication For Use Comparison Table

Characteristic	New DeviceUnipro	Predicate DeviceUltima NEO	Comparison
Manufacturer	Tenscare Limited	EasyMed InstrumentsCo., Ltd	-
510(k) No.	K232441	K120054	-
Indications forUse	TENS stands for Transcutaneous ElectricalNerve Stimulation. TheUnipro TENS system is usedto provide symptomatic painrelief for chronic, acute orpost-operative pain.EMS stands for ElectricalNeuromuscular Stimulator.The Unipro EMS system isindicated for:-Relaxation of muscle spasm-Increasing local bloodcirculation and muscle re-education-Prevention or retardation ofdisuse atrophy-Prevention of venousthrombosis of the calfmuscles immediately aftersurgery-Maintaining or increasingrange of motion.MIC stands for MicrocurrentStimulation. -The UniproMIC system is used toprovide symptomatic painrelief for chronic intractablepain, post traumatic pain orpost-surgical pain.	TENS stands for Transcutaneous ElectricalNerve Stimulation. TheUltima NEO TENSsystem is used to providesymptomatic pain relieffor chronic, acute or post-operative pain.EMS stands for ElectricalNeuromuscularStimulator. The UltimaNEO EMS system isindicated for:-Relaxation of musclespasm-Increasing local bloodcirculation and muscle re-education-Prevention or retardationof disuse atrophy-Prevention of venousthrombosis of the calfmuscles immediatelyafter surgery-Maintaining orincreasing range ofmotion.MIC stands forMicrocurrent Stimulation.The Ultima NEO MIC	Identical
Characteristic	New DeviceUnipro	Predicate DeviceUltima NEO	Comparison
	IF stands for InterferentialStimulation. The Unipro IFsystem is indicated for:-Symptomatic relief ofchronic intractable pain.	system is used to providesymptomatic pain relieffor chronic intractablepain, post traumatic painor post-surgical pain.IF stands for InterferentialStimulation. The UltimaNeo system is indicatedfor:-Symptomatic relief ofchronic intractable pain.
Intendedpopulation	Male and female patientsover the age of 21 requiringpain relief for various typesof pain, progress theirrehabilitation post injury andencourage results fromsports training. Targetpopulation includes thosewho fit this criteria withchronic, acute or post-operative pain and/orMusculo-skeletal injuries.The device should not beused by patients:- Under the age of 22- During first threemonths ofpregnancy- Who have apacemaker or heartrhythm problems	Male and female patientsover the age of 18 yearsold.	Substantially Equivalent
Class	II	II	Identical
Product code	GZJ, IPF, LIH	GZJ, IPF, LIH	Identical
Regulationnumber	21 CFR 882.5890 and 21CFR 890.5850	21 CFR 882.5890 and 21CFR 890.5850	Identical
Characteristic	New Device	Predicate Device	Comparison
DeviceName/Model	Unipro	Ultima NEO
510(k)	K232441	K120054
Manufacturer	TensCare Ltd	EasyMed Instruments Co.,Ltd
Power Source(s)¹	3.7V 1500mAh Lithium-ionbattery(rechargeable)	3.7V Lithium-ionbattery(rechargeable)	No substantialdifference
Method of Linecurrent Isolation	Sequential isolation /transformer isolation	Not publicly available
Average DC currentthrough Electrodeswhen device is on butno pulses are beingapplied (µA)	0	0	Identical
Number of OutputModes	4	4	Identical
Number of programsmodes	76	41	No substantialdifference.Both comply withIEC 60601-1requirements
Number of OutputChannels	2	2	Identical
TimerRange(minutes)	5-90 minutes, constant	10-90 minutes, constant	No substantialdifference.Unipro can be set tolower setting
Regulated Current orVoltage?	Current and Voltage	Current and Voltage	Identical
Software/Firmware/MicroprocessorControl?	Yes	Yes	Identical
Automatic No-LoadTrip?	Yes (TENS/EMS)	Not publicly available
Automatic OverloadTrip?	No	Not publicly available
Automatic Shut Off?	Yes	Not publicly available
User OverrideControl?	Yes	Not publicly available
Indicator Display:-On/Off status-Low battery-Voltage/Currentlevel-Time to cut-off	YesYesYesYes	YesYesYesYes	Identical
CharacteristicDeviceName/Model	New Device	Predicate Device	Comparison
Unipro	Ultima NEO
ComplianceVoluntaryStandards?	IEC 60601-1IEC 60601-1-2IEC 60601-2-10IEC 60601-1-11IEC 62304IEC 60601-1-6IEC 62366-1ISO 10993- 5, 10 and 12ISO 14971ISO 13485	IEC 60601-1IEC 60601-1-2IEC 60601-1-4IEC 60601-2-10IEC/EN 62304ISO 14971ISO 13485IC council 93/42/EECUL 60601-1	Substantialequivalent
Compliance with 21CFR 890.5850 and21 CFR 882.5890	Yes	Yes	Identical
Dimensions (mm)	125mm x 62mm x 29.6mm.	123 x 61 x 22mm (excludingbelt clip)	Different, the different dimensions does not affect the safety and effectiveness.
Weight g	128.5g	160g (including battery)	Different, the different weight does not affect the safety and effectiveness.
HousingMaterialsand Construction	ABS 757 material	ABS 757 material	Identical
Sterilization	N/A	N/A	Identical

Tenscare Ltd., Traditional 510(k) Unipro

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5.7. Technological comparison

Table 2: Basic Unit Characteristics Comparison Table

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Tenscare Ltd., Traditional 510(k)
Unipro

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Table 3: Comparison of output specifications

	New DeviceUniPro	Predicate DeviceUltima NEO	Comparison
510(k) No.	K232441	K120054	/

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Waveform	TENS/EMS:	TENS/EMS
	TENS/EMS:SymmetricalRectangular	Bi-phase SymmetricalRectangular	No substantialdifference -Waveforms are notsubstantially differentin TENS andMicrocurrent
		AsymmetricalRectangular
		Mono-PhaseSymmetricalRectangular	rectangular MicrocurrentBi-Polar programs. UltimaNEO consists of threeadditional waveformsin TENS program.
	Microcurrent:continuoussquare unipolarsawtooth unipolarSymmetrical balancedwave	Microcurrent:SymmetricalRectangular	Both comply withIEC 60601-1requirements.
		rectangular
	IFT:Symmetrical balancedwave	IFT:Symmetrical balanced sinewave	Identical-Waveformsare identical in IFTand EMS programs.
Maximum OutputVoltage (V)	TENS/EMS:54V@500Ω114 V@2 kΩ116 V@10 kΩ	TENS/EMS:73.6V@500Ω120V@2 kΩ124V@10 kΩ	No substantialdifference.TENS/EMS and MICvoltage values arelower than UltimaNEO.Both comply withIEC 60601-1requirements.The difference involtage isproportional to thecurrent ( Since theresistance is the samein both productV=IxR).Therefore, poses nofurther risk or safetyconcerns.
	Microcurrent:0.4V@500Ω1.56 V@2 kΩ7.8 V@10 kΩ	Microcurrent:0.54V@500Ω2.12V@2 kΩ10.2V@10 kΩ
	IFT:24V@500Ω34.4 V@2 kΩ40 V@10 kΩ	IFT:17V@500Ω30V@2 kΩ32 V@10 kΩ
Maximum OutputCurrent (mA)	TENS/EMS:108mA@500Ω (200μs)80mA @500Ω (400μs)57mA@2 kΩ11.6 mA@10 kΩ	TENS/EMS:147mA@500Ω60mA@2 kΩ12.4mA@10kΩ	No substantialdifference.Unipro features anamplitudemodulation mode, inwhich waveforms arepre-modulated.
	Microcurrent:	Microcurrent:1.08mA@500Ω
	0.8mA@500Ω	1.06mA@2 kΩ	Unipro MIC
	0.78 mA @2 kΩ	1.02mA@10kΩ	amplitude of 0.8mAis significantlysmaller than UltimaNeo and thereforeposes no further riskor safety concerns.Both comply withIEC 60601-1requirements.
	0.78 mA @10 kΩ	IFT/Amplitude Modulation:
	IFT:48mA@500Ω17.2mA@2 kΩ4mA@10 kΩ	34mA@500Ω15mA@2 kΩ3.2mA@10kΩ
Pulse Width (µs)	TENS: 50-300 µsEMS: 100-400 µsMicrocurrent: 10-200msIFT: 125 µs	TENS/EMS: 50-400µsMicrocurrent: 2-200msIFT:120-125µs	No substantialdifference. UniproTENS/EMS and IFTpulse width range arewithin recommendedoutput, both complywith IEC 60601-2-10.
Frequency(Hz)	TENS: 2-150HzEMS: 10-120HzMicrocurrent: 0.5Hz, 1Hz,1.5Hz, 2Hz, 3Hz, 4Hz, 5Hz to50HzIFT: 2-160Hz (CarrierFrequency: 4000Hz fixed(CH1))	TENS/EMS:1-150HzMicrocurrent: 1-150HzIFT:4000-4160Hz	No substantialdifference.The higher frequencyoffered by UltimaNEO may not provideany additional benefitin treatment.frequency is stillwithin therecommended range.Both comply withIEC 60601-2-10.
Net Charge (µC perpulse)	0.3µC@ 500 Ω	0.4µC@ 500 Ω	No substantialdifference -The Charge output isdependent on currentand only used to setthe pulse width,therefore variation isirrelevant totreatment.Charge per pulse(µC) = pulse width(ms) xcurrent (mA).Both comply withIEC 60601-1requirements.

Tenscare Ltd., Traditional 510(k)
Unipro

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MaximumPhaseCharge, (μC)	TENS/ EMS:	TENS/ EMS:	No substantialdifference.
	22.76μC@500ΩMicrocurrent:160μC@500ΩIFT:2.8μC@500Ω	21.62μC@500ΩMicrocurrent:220.8μC@500ΩIFT:5.16μC@500Ω	Charge per pulse(μC) = pulse width(ms) xcurrent (mA);The Charge is used toset the pulse width,therefore variation isirrelevant totreatment.Both comply withIEC 60601-1requirements.
Maximum CurrentDensity, (mA/cm²)	TENS/EMS:0.8mA/cm²@500ΩMicrocurrent:0.008mA/cm²@500ΩIFT:0.82mA/cm²@500Ω	TENS/ EMS:5.88mA/cm²@500ΩMicrocurrent:0.022mA/cm²@500ΩIFT:1.65mA/cm²@500Ω	No substantialdifference - bothcomply with IEC60601-1requirements.
Maximum PowerDensity, (W/cm²)	TENS/ EMS:0.0076 W/cm2Microcurrent:0.0001049 W/cm2IFT	TENS/ EMS:0.0086W/cm²(150Hz)Microcurrent:0.012W/cm²(150Hz)IFT:	No substantialdifference - bothcomply with IEC60601-1requirements

Rationale for equivalence claim:

The Unipro and the specified equivalent device are intended to combine TENS, IFT, EMS and MIC technologies to assist with management of a range of conditions (as appropriate to the selected technology), including chronic , acute, and post-operative pain as well as muscle training, toning, bulking and reeducation.

The devices have a near-identical principle of operation, all involving the administration of the device onto the skin at anatomical locations suitable for the identified clinical problem. All technologies within the devices are extremely well-established in the market and neither the technologies nor their combination in a single device is novel. As will be demonstrated through the information presented in this section, these devices could be used interchangeably for performing the target procedure.

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5.8. Labeling comparison:

Unipro labeling is substantially equivalent to the predicate device, Ultima NEO label.

Summary of Technological Characteristics Compared to the Predicate Devices 5.9

Transcutaneous Electrical Nerve Stimulation (TENS), Electrical Muscle Stimulation (EMS), Microcurrent (MIC) and Interferential (IF) system are the technological principles for both the Unipro and the predicate device.

The subject and predicate device are based on the following same technological elements:

. The new device Unipro is a portable electrotherapy device which combines four systems: Transcutaneous Electrical Nerve Stimulation (TENS), Electrical Muscle Stimulation (EMS), Microcurrent (MIC) and Interferential (IF), into one enclosure. These four systems work separately. When one system is working, the others do not work and thus do not affect each other. This feature has been fully guaranteed by the design. The marketed device Ultima NEO is also a portable electrotherapy device which combines four systems: Transcutaneous Electrical Nerve Stimulation (TENS), Electrical Muscle Stimulation (EMS), Microcurrent (MIC) and Interferential (IF), into one enclosure. These four systems work separately. When one system is working, the others do not work and thus do not affect each other. This feature has been fully guaranteed by the design.
. The new device Unipro combines the systems of TENS and EMS into one package. It is also substantial equivalent to the marketed device Ultima NEO, their features and performances in muscle stimulation as well as pain relief therapy are substantially equivalent.
The designed circuitry of TENS and EMS modes in the new device Unipro is almost the same as . the marketed device Ultima NEO. For the TENS and EMS systems, they are very similar in terms of circuit diagrams and same working principle; the marketed device Ultima NEO combines the Microcurrent (MIC) and Interferential (IF) systems into one package, but these systems are worked separately which is same in the Unipro.
The marketed device Ultima NEO is a device which includes the Microcurrent stimulation system. . Microcurrent stimulation can be generated by a very low and relatively long period current. The specification of microcurrent system in Ultima NEO is very similar to that of Unipro MIC system.

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. The marketed device Ultima NEO is an interferential stimulator which generates the real-sine waves of electrical current. The specification of Ultima NEO is very similar to that of Unipro IF svstem.
The new device Unipro is designed and combined the Interferential (IF) and Micro-current (MIC) . systems based on the design of Ultima NEO.
The new device Unipro is of the same ranges of parameters as those of marketed device Ultima . NEO.
. The software of the new device Unipro can be divided into four parts: the first for TENS system, the second for EMS system, the third for MIC system, and the four one for IF system. First of all, the part of software for TENS system of the new device Unipro is only a subset of that of the marketed device Ultima NEO. Secondly, the considerations on safety, effectiveness and reliability in Ultima NEO are also introduced into the EMS system of the new device; While the part of software for EMS system of the new device Unipro is almost the same as that of the marketed device Ultima NEO, by applying almost the same control methods for muscle contractionrelaxation. In other word. the TENS and EMS systems of the new device Unipro are almost the same as those of the marketed device Ultima NEO. Thirdly, the part of software for Microcurrent (MIC) system of the new device Unipro is very similar to that of the marketed device Ultima NEO. For the last, the part of software for Interferential (IF) system of the new device Unipro is very similar to that of the marketed device Ultima NEO.
The accessories of the new device Unipro are similar to those of Ultima NEO, the marketed device. ●
Both the new device Unipro and the marketed device Ultima NEO are passed the same tests of . applicable recognized international consensus standards.

Summary of Non-Clinical Performance Testing as Basis for Substantial Equivalence 5.10

Unipro has undergone extensive bench testing to provide evidence that its mechanical, electrical and software properties are substantially equivalent to the predicate devices, Ultima NEO (K120054). Both Subject and Predicate devices are provided non-sterile, have comparable operations and technology. The design of Unipro does not introduce any new risks.

Summary of Clinical Testing as Basis for Substantial Equivalence 5.11

No clinical testing was considered necessary.

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Tenscare conducted a formal review of published research and clinical evaluation on the use of TENS, EMS, IFT and MC in pain relief for chronic, acute, or post-operative pain as well as muscle training, toning, bulking and re-education to establish evidence of the safety and effectiveness of these settings for this Indicated Use and electrode positions.

5.12 Conclusions

TensCare Ltd considers Unipro to be substantially equivalent to the predicate device Ultima NEO (K120054). This conclusion is based upon the devices' similarity in principles of operation, technology, materials, biological, clinical characteristics as well as indications for use.

Any identified differences between the Unipro and equivalent device are minor and of no consequence to safety or performance; most differences are based on commercial decisions and/or are intended to optimise patient comfort and user experience without altering efficacy. Access to data is sufficient to provide the manufacturer with sufficient information about the equivalent devices to support an equivalence claim, since the main data required to form a claim of equivalence relates to technical aspects of the devices (which are technical settings and performance parameters, details of which are available in the public domain) and other information (such as indications/contraindications and mode of action) which are also available in the public domain.

Therefore, the information submitted to the FDA for the Unipro does not raise new questions about safety or effectiveness and demonstrates with reasonable assurance based on stablished controls that the device is at least as safe and effective as a legally marketed device.

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).