TrueRelief is intended for temporary symptomatic relief of chronic intractable pain, and as an adjunctive treatment in the management of post-surgical and post-traumatic acute pain.

Device Description

The TrueRelief device is an AC power operated device that consists of three main components and associated power cables: the pulse generator, a primary probe and a secondary probe. The signal generator applies electromagnetic energy transcutaneously through the primary and secondary probes into painful tissue, similar to Transcutaneous Electrical Nerve Stimulation (TENS) device. The TrueRelief device uses a proprietary waveform with small voltage fluctuations to achieve pain relief.

AI/ML Overview

This 510(k) summary describes a TENS device, which is not an AI/ML device. Therefore, the requested information regarding AI/ML device performance and associated studies (acceptance criteria, sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details) is not applicable.

The document focuses on demonstrating substantial equivalence to predicate devices through technical comparisons and compliance with electrical safety and electromagnetic compatibility standards.

Here's a breakdown of the relevant information provided:

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

The document lists "Performance Testing" as a comparable characteristic between the subject device (TrueRelief Device) and its predicates. It states that "The TrueRelief Device was tested and certified to comply with recognized standards for electrical safety (IEC 60601-1, IEC 60601-2-10, IEC 60601-1-6)" and "Electromagnetic Compatibility: The TrueRelief Device was tested and certified to comply with recognized standards for electromagnetic compatibility (IEC 60601-1-2)." It also mentions "Usability/Human Factors: Usability/Human Factors were evaluated, which demonstrated that the established requirements for usability were met, and the device's design is appropriate for the intended users and use environment."

The specific acceptance criteria (e.g., maximum leakage current values) are implicitly defined by the standards listed, and the "reported device performance" is that it "complies" with these standards. The comparative table of technological characteristics also lists specific electrical parameters for the device (e.g., Patient Leakage Current <100uA for normal conditions, <300uA for single fault condition) that the device must meet to be considered substantially equivalent to the predicate.

2. Sample size used for the test set and the data provenance: Not applicable. These are not AI/ML device studies. Performance testing here refers to engineering and electrical safety tests, not clinical performance studies with patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth and expert adjudication are not relevant for electrical safety and EMC testing.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.

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 is not an AI/ML device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/ML device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. For electrical devices, "ground truth" refers to compliance with established engineering and safety standards.

8. The sample size for the training set: Not applicable. This is not an AI/ML device.

9. How the ground truth for the training set was established: Not applicable. This is not an AI/ML device.

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, with the letters "FDA" in a blue square. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

TrueRelief % Kristen Allen Founder and Principal Consultant AllenBridge Consulting 2221 Oleander Drive Wilmington, North Carolina 28403

March 23, 2021

Re: K202186

Trade/Device Name: TrueRelief Device Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator For Pain Relief Regulatory Class: Class II Product Code: GZJ Dated: March 16, 2021 Received: March 17, 2021

Dear Kristen Allen:

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. 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 located 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.

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

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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 803) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-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,

for Pamela Scott Assistant Director DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

Device Name TrueRelief Device

Indications for Use (Describe)

The TrueRelief Device is intended for use under the supervision of a Healthcare Professional.

TrueRelief is intended for temporary symptomatic relief of chronic intractable pain, and as an adjunctive treatment in the management of post-surgical and post-traumatic acute 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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Image /page/3/Picture/0 description: The image shows the logo for TrueRelief. Above the name is a graphic of a sound wave in shades of orange, purple, and blue. The name TrueRelief is written in a blue font, with the word True in a darker shade of blue than the word Relief.

510(k) Summary

TrueRelief Device

Submitter:	True Relief100 Wilshire Boulevard, Suite 700Santa Monica, CA 90401310.918.9064 (P)
Contact Person:	Kristen AllenPrincipal Consultant, Regulatory, Quality andCompliance910-612-4153 (P)kallen@truerelief.com
Date Prepared:	March 23, 2021
Trade Name:	TrueRelief Device
Common Name:	Transcutaneous Electrical Nerve Stimulator (TENS) for painrelief
Device Product Codeand Classification:	Regulation Number: 21 CFR 882.5890GZJ, Class II, Transcutaneous Electrical Nerve Stimulator(TENS) for pain relief
Primary Predicate:	TrueRelief Device (originally NewLife Sciences TMR device)K070474
Additional Predicates:	DJO Chattanooga Revolution Wireless, K153696

Device Description:

Indications and Intended use:

The TrueRelief Device is intended for use under the supervision of a Healthcare Professional.

TrueRelief is intended for temporary symptomatic relief of chronic intractable pain, and as an adjunctive treatment in the management of post-surgical and post-traumatic acute pain.

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Image /page/4/Picture/0 description: The image contains the logo for TrueRelief. Above the name is a graphic of four diamonds in a row, each a different color. The name TrueRelief is written in two different colors, with True in blue and Relief in purple.

Comparison of Technological Characteristics With The Predicate Device:

The subject and predicate devices have similar technological characteristics and the minor differences do not raise any new issues of safety and effectiveness. The following characteristics are similar between the subject device and predicate devices:

. Indications for use
. Principle of operation
Technological characteristics .
. Performance testing

Comparison with Predicate Devices

Item	Primary Predicate DeviceK070474 TMR	Reference DeviceK153696	Subject DeviceTrueRelief
Intended Use /Indications forUse	TrueRelief is intended fortemporary symptomatic reliefof chronic intractable pain, andas an adjunctive treatment inthe management of post-surgical and post-traumaticacute pain.	The ChattanoogaRevolution Wireless is aclinical electrotherapydevice intended for useunder the supervision ofa HealthcareProfessional.As a TENS device,indications are for thefollowing conditions:- Symptomatic relief andmanagement of chronic,intractable pain - Post-surgical and post-traumaacute pain	The TrueRelief Device isintended for use underthe supervision of aHealthcare Professional.TrueRelief is intended fortemporary symptomaticrelief of chronicintractable pain, and asan adjunctive treatment inthe management of post-surgical and post-traumatic acute pain.
Prescription/Professional UseOnly or OTC	Prescription	Prescription/Professional Use Only	Prescription/Professional Use Only
Where used	Physician office, physicaltherapy clinic, hospital nursinghome, post acute care,chiropractic clinic	Physician office,physical therapy clinic,hospital nursing home,post acute care,chiropractic clinic	Physician office, physicaltherapy clinic, hospitalnursing home, post acutecare, chiropractic clinic
Target population	Adult population	Adult population	Adult population
Battery or mainspowered	Mains	Mains and batteryoperated	Mains
Principle ofOperation	External nerve stimulator thatgenerates an electrical pulsethat is delivered to the tissuethrough the primary andsecondary probes	External nerve stimulatorthat generates anelectrical pulse that isdelivered to the tissuethrough the primary andsecondary probes	External nerve stimulatorthat generates anelectrical pulse that isdelivered to the tissuethrough the primary andsecondary probes
Sterility	Non-Sterile	Non-sterile	Non-sterile
Materials	Patient contact material: 316Lstainless steel	Patient contact material:stainless steel	Patient contact material:316L stainless steel
Connection ofdevice toelectrodes	The device uses twoelectrodes(probes) using asingle channel. At one end ofeach probe is a 316 stainless	Stimulation Module isdirectly connected to thecustom male SNAPassembled in the	The device uses twoelectrodes(probes) usinga single channel. At oneend of each probe is a
Item	Primary Predicate DeviceK070474 TMR	Reference DeviceK153696	Subject DeviceTrueRelief
	steel tip that touches thepatient and the other end ofthe stainless steel tip screwsinto the probe. On the otherend of the probe is a cablewhich connects each probe tothe device using a connectorwith pins.	electrode. User Interface(LCD and buttons) isphysically separated(Remote Control) andcommunicates wirelesslywith up to four (4)stimulation modules.Stimulation safetyremains fully managedby Stimulation Moduleelectronic circuit itself.	316 stainless steel tip thattouches the patient andthe other end of thestainless steel tip screwsinto the probe. On the otherend of the probe isa cable which connectseach probe to the deviceusing a connector withpins.
Power Supply	115 VAC, 60Hz input12 volt DC output	Rechargeable battery	115 VAC, 60Hz input12 volt DC output
Electrical Type	Type BF	NABattery operated device	Type BF
Patient LeakageCurrent - NormalCondition (µA)	<100uA patient leakage	NABattery operateddevice	<100uA patient leakage
Patient LeakageCurrent - SingleFault Condition(μΑ)	<300uA line leakage	NABattery operateddevice	<300uA line leakage
Number ofOutput Channels	1	0, 2, or 4	1
Method ofChannel Isolation	Transformer isolated.	Each channel is themiddle of a H Bridge.Except when it isactivated, eachchannel is always in highimpedance state	Transformer isolated.
RegulatedCurrent orRequlatedVoltage (outputsignals only)	Regulated current on onlychannel	Regulated current on allchannels	Regulated current ononly channel
MaximumCurrent (RMS)Density(mA/cm2)	14mA/cm2Average of 2.1mA/cm2	1.34mA/cm2	14mA/cm2Average of 2.1mA/cm2
Maximum PowerDensity[mW/cm²]	79 mW/cm2 @5000Average of 11mW/cm2@5000	14.4 [mW/cm²] @500Ω	79 mW/cm2 @5000Average of 11mW/cm2@5000
Output Voltage	Range of normal use: 50-60 VPeak pulse amplitude: 200 V	60 V @ 500 Ω180V @ 2 kΩ180 V @ 10 kΩ	Range of normal use: 50-60 VPeak pulse amplitude:200 V
Pulse Rate	1 to 400 (+10%) Pulse /Second (Low)4,000 (-5%) to 20,000 (+10%)Pulse/Second (High)	35 - 80 Hz	1 to 400 (+10%) Pulse /Second (Low)4,000 (-5%) to 20,000(+10%) Pulse/Second(High)
Item	Primary Predicate DeviceK070474 TMR	Reference DeviceK153696	Subject DeviceTrueRelief
Pulse Duration	0.24-0.74 millisecond (Low)15-25 microsecond (High)	300 to 400 [μs](microseconds)	0.24-0.74 millisecond(Low)15-25 microsecond (High)
Output Current(maximum)	8.9 milliamps (at bodyresistance > 10.11K ohms)	120 mA @ 500 Ω90 mA @ 2 kΩ18 mA @ 10 kΩ	8.9 milliamps (at bodyresistance > 10.11Kohms)
Maximum ChargePer Pulse	7 μC	36 [μC] @ 500Ω	7 μC
Wave FormShape	Rectangular	Rectangular	Rectangular
MaximumAmplitude	No load - 200 V PeakWith 50K ohm load - 175 VPeak	60 V @ 500 Ω180V @ 2 kΩ180 V @ 10 kΩ	No load - 200 V PeakWith 50K ohm load - 175V Peak

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Image /page/5/Picture/0 description: The image shows the logo for TrueRelief. The logo consists of the word "TrueRelief" in a sans-serif font, with "True" in a dark blue color and "Relief" in a lighter blue color. Above the word is a graphic of four diamond shapes in a row, with the colors of the diamonds being orange, pink, purple, and blue.

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Image /page/6/Picture/0 description: The image shows the logo for TrueRelief. Above the name is a graphic of a sound wave in different shades of purple and orange. The name TrueRelief is written in a combination of blue and purple.

Summary of Performance Testing:

Electrical Safety: The TrueRelief Device was tested and certified to comply with recognized standards for electrical safety (IEC 60601-1, IEC 60601-2-10, IEC 60601-1-6).

Electromagnetic Compatibility: The TrueRelief Device was tested and certified to comply with recognized standards for electromagnetic compatibility (IEC 60601-1-2).

Usability/Human Factors: Usability/Human Factors were evaluated, which demonstrated that the established requirements for usability were met, and the device's design is appropriate for the intended users and use environment. The result of this evaluation substantiates the acceptability of the use-related risks identified during the risk assessment activities.

Conclusion:

Based on the performance testing and the similarities of the indications for use and the technological characteristics, it can be concluded that the TrueRelief Device is as safe and effective as, and substantially equivalent to, the predicate device(s).

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).