It is intended for temporary relief of pain associated with sore and aching muscles in the shoulder, neck, back, waist, abdomen, lower extremities (legs), upper extremities (arms) due to strain from exercise or normal household and work activities.
It is also intended for symptomatic relief and management of chronic, intractable pain associated with arthritis.
EMS:
To stimulate healthy muscles to improve and facilitate muscle performance. To be used for the improvement of muscle tone and firmness, and for strengthening muscles in the intended areas on the body.
To be used for relaxation of muscle spasm, increase of blood flow circulation, prevention or retardation of disuse atrophy, muscle re-education, maintaining or increasing range of motion, and immediate post-surgical stimulation of calf muscles to prevent venous thrombosis.

Device Description

RelieforMe TENS/EMS Device model UPK-GE01 is designed to focus on pain relief, muscle strengthening and recovery features with TENS/EMS treatment techniques driven and controlled by intelligent programs/software.
RelieforMe TENS/EMS Device, a TENS/EMS combination device, is intended for temporary relief of pain associated with sore and aching muscles in the shoulder, neck, back, waist, abdomen, lower extremities (leg), upper extremities (arm) due to strain from exercise or normal household and work activities. The device is for 18 and older.
The device provides pain relief based on the intelligent use of the key pain-killer mechanisms of TENS (Transcutaneous Electrical Nerve Stimulation).

AI/ML Overview

The provided document is a 510(k) Premarket Notification for the "RelieforMe TENS/EMS Device Model UPK-GE01". It is a submission to the FDA seeking to demonstrate substantial equivalence to legally marketed predicate devices, not an AI/ML device. Therefore, the information requested about acceptance criteria, study details, expert consensus, ground truth, and training sets for an AI/ML device is not applicable or present in this document.

The document focuses on comparing the subject device's features (such as power sources, output voltage/current, frequency, pulse width, biocompatibility, electrical safety, and EMC) to those of predicate TENS/EMS devices to show that it is "as safe and effective as the predicate device" and does "not raise new questions of safety and effectiveness."

Specifically, the document states:

Non-Clinical Performance Data: "To demonstrate safety and effectiveness of RelieforMe TENS/EMS Device model UPK-GE01 and to show substantial equivalence to the predicate device, UMHEAL completed the following non-clinical tests. Results confirm that the design inputs and performance specifications for the device are met. The UPK-GE01 passed the testing in accordance with international standards shown below, supporting its safety and effectiveness, and its substantial equivalence to the predicate device:"
- Electrical safety testing per IEC 60601-1 – Passed
- Electromagnetic Disturbance (EMD) testing per IEC 60601-1-2 – Passed
- Software verification and validation per FDA Guidance – results /conclusion
- Treatment Programs Performance Verification Testing
- Stability Verification Testing
- HFE Validation Testing
- FCC Testing
- Transportation Testing per ASTM D4169 – Demonstrates package integrity maintained
Clinical Performance Data: "Not applicable."

Therefore, I cannot provide the requested information regarding AI/ML specific criteria from this document.

Summary

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December 23, 2019

UMEHEAL Ltd. % Randy Jiang Senior Consultant Emergo Global Consulting , LLC 2500 Bee Cave Road, Building 1, Suite 300 Austin, Texas 78746

Re: K192733

Trade/Device Name: RelieforMe TENS/EMS Device Model UPK-GE01 Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: IPF, GZJ, NUH Dated: September 3, 2019 Received: September 27, 2019

Dear Randy Jiang:

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.

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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 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 Vivek Pinto, Ph.D. 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) K192733

Device Name

RelieforMe TENS/EMS Device Model UPK-GE01

Indications for Use (Describe)

TENS:

It is intended for temporary relief of pain associated with sore and aching muscles in the shoulder, neck, back, waist, abdomen, lower extremities (legs), upper extremities (arms) due to strain from exercise or normal household and work activities.
It is also intended for symptomatic relief and management of chronic, intractable pain associated with arthritis.

EMS:

To stimulate healthy muscles to improve and facilitate muscle performance. To be used for the improvement of muscle tone and firmness, and for strengthening muscles in the intended areas on the body.
To be used for relaxation of muscle spasm, increase of blood flow circulation, prevention or retardation of disuse atrophy, muscle re-education, maintaining or increasing range of motion, and immediate post-surgical stimulation of calf muscles to prevent venous thrombosis.

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

Prescription Use (Part 21 CFR 801 Subpart D)

X Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

1. Submission Sponsor

UMEHEAL Ltd Floor 5, Bld F4, 1001 Zhongshanyuan Rd, TCL E City, Nanshan District Shenzhen, Guangdong, P.R. China 518055 Contact: Lin Rui Title: General Manager

2. Submission Correspondent

Emergo Global Consulting, LLC 2500 Bee Cave Road Building 1, Suite 300 Austin, TX 78746 Office Phone: (512) 327-9997 Email: LST.AUS.ProjectManagement@ul.com Contact: Randy Jiang Title: Senior Consultant

3. Date Prepared

11/20/2019

4. Device Identification

Trade or Proprietary Name: RelieforMe TENS/EMS Device Model UPK-GE01 Common or Usual Name: Powered Muscle Stimulator Regulation Number: 890.5850, 882.5890 IPF, GZJ, NUH Product Code: Class: Class 2 Panel: Neurology

5. Legally Marketed Predicate Device(s)

Device name: Mini TENS DEVICE (Model KRES102), TENS & EMS DEVICE (Model KRES100B) Model: KRES100B 510(k) number: K172933 Manufacturer: Shenzhen Conree Technology Co.,Ltd

Device name: Electronic Pulse Stimulator 510(k) number: K162517 Manufacturer: JKH Health Co., Ltd.

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Device name: Pulserelief 510(k) number: K151035 Manufacturer: PHILIPS CONSUMER LIFESTYLE

Reference devices:

Device name: JIAJIAN self-adhesive electrode 510(k) number: K090198 Manufacturer: WUXI JIAJIAN MEDICAL INSTRUMENT CO., LTD.

Device name: SYNAPTIC 3000 510(k) number: K940954 Manufacturer: THE SYNAPTIC CORP.

6. Indication for Use Statement

TENS:

It is intended for temporary relief of pain associated with sore and aching muscles in the shoulder, neck, back, waist, abdomen, lower extremities (leg), upper extremities (arm) due to strain from exercise or normal household and work activities.
It is also intended for symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis.

EMS:

To stimulate healthy muscles to improve and facilitate muscle performance. To be used for the improvement of muscle tone and firmness, and for strengthening muscles in the intended areas on the body.
To be used for relaxation of muscle spasm, increase of blood flow circulation, prevention or retardation of disuse atrophy, muscle re-education, maintaining or increasing range of motion, and immediate postsurgical stimulation of calf muscles to prevent venous thrombosis.

7. Device Description

RelieforMe TENS/EMS Device, a TENS/EMS combination device, is intended for temporary relief of pain associated with sore and aching muscles in the shoulder, neck, back, waist, abdomen, lower extremities (leg), upper extremities (arm) due to strain from exercise or normal household and work activities. The device is for 18 and older.

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The device provides pain relief based on the intelligent use of the key pain-killer mechanisms of TENS (Transcutaneous Electrical Nerve Stimulation).

8. Substantial Equivalence Discussion

The following table compares the RelieforMe TENS/EMS Device Model UPK-GE01 to the predicate device with respect to indications for use, principles of operation, technological characteristics, and performance, and forms the basis for the determination of substantial equivalence. The subject device does not raise any new questions of safety or effectiveness as compared to the predicate device.

Table 5A – Comparison of Characteristics

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Attribute	SUBJECT DEVICE	PREDICATE DEVICE 1	PREDICATE DEVICE 2	PREDICATE DEVICE 3
	RelieforMe TENS & EMSDEVICE	Mini TENS DEVICE(Model KRES102), TENS& EMS DEVICE	ElectronicStimulator	PulsePulserelief
	Model:UPK-GE01	Model KRES100B
	facilitate muscleperformance. To beused for theimprovement of muscletone and firmness, andfor strengtheningmuscles in the intendedareas on the body.	abdomen, and leg due tostrain from exercise ornormal household andwork activities.	muscle performance.To be used for theimprovement ofmuscle tone andfirmness, and forstrengtheningmuscles in the arms,abdomen, legs, andbuttocks. Notintended for use inany therapy or for thetreatment of anymedical conditions ordiseases. It is alsointended totemporarily increaselocal blood circulationin the healthymuscles of lowerextremities.
	To be used forrelaxation of musclespasm, increase ofblood flow circulation,prevention orretardation of disuseatrophy, muscle re-education, maintainingor increasing range ofmotion, and immediatepost-surgicalstimulation of calfmuscles to preventvenous thrombosis.	EMS: It is used forrelaxation of musclespasm, increase of bloodflow circulation,prevention orretardation of disuseatrophy, muscle re-education, maintainingor increasing range ofmotion, and immediatepost-surgical stimulationof calf muscles to preventvenous thrombosis	Heating ModeTemporary relief ofminor aches andpains.
Power Sources	Lithium Ion Polymerbattery	3.0V210mAh Buttonlithium manganesebattery	Rechargeable battery	Li-ion 3.7V 500mAh
Software/Firmwareare/Microprocessorcontrol	Yes	Yes	Yes	Yes
AutomaticOverload Trip	Yes	Yes	Unknown	Yes
Automatic No- loadTrip	Yes	Yes	Unknown	Yes
Automatic Shut Off	Yes	Yes	Unknown	Yes
MaximumOutput Voltage	61V ± 20%@ 500Ω65V ± 20%@ 2kΩ65V± 20%@ 10kΩ	28.2V @500Ω48.4V @ 2kΩ82V @ 10kΩ	@ 500Ω:Mode 1: This modecyclesthe following modesMode 2: 36.4V ± 20%Mode 3: 47.6V ± 20%Mode 4: 57.6 V± 20%	Both TENS & EMS:31V ± 20% @ 500Ω69V ± 20% @ 2kΩ70V ± 20% @ 10kΩ

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Attribute	SUBJECT DEVICE	PREDICATE DEVICE 1	PREDICATE DEVICE 2	PREDICATE DEVICE 3
	RelieforMe TENS & EMSDEVICE	Mini TENS DEVICE(Model KRES102), TENS& EMS DEVICE	ElectronicStimulator	Pulse Pulserelief
	Model:UPK-GE01	Model KRES100B
			Mode 5: 29.6V ± 20%Mode 6: 29.6V ± 20%Mode 7: 40.8V ± 20%Mode 8: 24.0V ± 20%
			@ 2kΩ:Mode 1: This modecyclesthe following modesMode 2: 80.8V ± 20%Mode 3: 96.0V ± 20%Mode 4: 93.6V ± 20%Mode 5: 66.4V ± 20%Mode 6: 66.4V ± 20%Mode 7: 86.4V ± 20%Mode 8: 53.6V ± 20%
			@ 10kΩ:Mode 1: This modecyclesthe following modesMode 2: 134V ± 20%Mode 3: 132V ± 20%Mode 4: 108V ± 20%Mode 5: 126V ± 20%Mode 6: 126V ± 20%Mode 7: 129V ± 20%Mode 8: 105V ± 20%
Maximum outputCurrent	122mA ± 20%@ 500Ω32.5mA ± 20%@ 2kΩ6.5mA ± 20%@ 10kΩ	56.4mA@500Ω24.2mA @ 2kΩ8.2mA@10kΩ	@ 500Ω:Mode 1: This modecyclesthe following modesMode 2: 72.8mA ± 20%Mode 3: 95.2mA ± 20%Mode 4: 115.2mA ± 20%Mode 5: 59.2mA ± 20%Mode 6: 59.2mA ± 20%Mode 7: 81.6mA ± 20%Mode 8: 48.0mA ± 20%	Both TENS & EMS:62mA± 20% @ 500Ω34mA± 20% @ 2kΩ7mA± 20% @ 10kΩ

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Attribute	SUBJECT DEVICERelieforMe TENS & EMSDEVICEModel:UPK-GE01	PREDICATE DEVICE 1Mini TENS DEVICE(Model KRES102), TENS& EMS DEVICEModel KRES100B	PREDICATE DEVICE 2ElectronicStimulatorPulse	PREDICATE DEVICE 3Pulserelief
			@ 2kΩ:Mode 1: This modecyclesthe following modesMode 2: 40.4mA ±20%Mode 3: 48.0mA ±20%Mode 4: 46.8mA ±20%Mode 5: 33.2mA ±20%Mode 6: 33.2mA ±20%Mode 7: 43.2mA ±20%Mode 8: 26.8mA ±20%@ 10kΩ:Mode 1: This modecyclesthe following modesMode 2: 13.4mA ±20%Mode 3: 13.2mA ±20%Mode 4: 10.8mA ±20%Mode 5: 12.6mA ±20%Mode 6: 12.6mA ±20%Mode 7: 12.9mA ±20%Mode 8: 10.5mA ±20%
Frequency range	For TENS:1~~1200HZFor EMS:1~~100HZ	1~117.3Hz	Mode 1: This modecyclesthe following modesMode 2: 62.5HZMode 3: 12.8~54.3HZMode 4: 1.19HZMode 5: 104.1HZMode 6: 104.1HZ	For TENS:1~100HZFor EMS:40 ~ 65 HZ

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Attribute	SUBJECT DEVICERelieforMe TENS & EMSDEVICEModel:UPK-GE01	PREDICATE DEVICE 1Mini TENS DEVICE(Model KRES102), TENS& EMS DEVICEModel KRES100B	PREDICATE DEVICE 2ElectronicStimulator	PREDICATE DEVICE 3Pulserelief
Pulse width range	TENS:4~~300µs;EMS:250~~400µs	TENS:96~~260µs;EMS:150~~260µs sss	Unknown	TENS: 60 ~ 350 µsEMS: 150 ~ 350 µs
Patient LeakageCurrent	<1uA	N/A	N/A	<10uA
Method of ChannelIsolation	N/A(1 output channel)	Unknown	Unknown	N/A(1 output channel)
Maximum PhaseCharge (μC)	TENS :36.6μC @ 500Ω9.75μC @ 2kΩ1.95μC @ 10kΩEMS :48.8μC @ 500Ω13.0μC @ 2kΩ2.6μC @ 10kΩ	N/A	@ 500Ω:Mode 1: This modecyclesthe following modesMode 2: 14.6μCMode 3: 19.0μCMode 4: 23.0μCMode 5: 11.8μCMode 6: 11.8μCMode 7: 16.3µCMode 8: 9.6µC	TENS:1.6~~6.8μC@500ΩEMS:4.7~~10.9μC@ 500Ω
For interferentialmodes only: - BeatFrequency (Hz)	N/A	N/A	N/A	N/A
For multiphasicwaveforms only: -Symmetrical phases?	YES	Unknown	Unknown	YES
Phase Duration	TENS:4~~300μsEMS:250~~400μs	Unknown	Unknown	TENS:25~~175µsEMS: 75~~175µs
Biocompatibility	Compliant withrequirements ofISO10993-5 andISO10993-10 standards	Compliant withrequirements ofISO10993-5 andISO10993-10 standards	Unknown	Unknown
Electrical Safety	Compliant withrequirements ofIEC60601-1, IEC60601-	Compliant withrequirements ofIEC60601-1, IEC60601-2-	Unknown	IEC 60601-1, IEC60601-2-10, ISO10993-5/10

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Attribute	SUBJECT DEVICERelieforMe TENS & EMSDEVICEModel:UPK-GE01	PREDICATE DEVICE 1Mini TENS DEVICE(Model KRES102), TENS& EMS DEVICEModel KRES100B	PREDICATE DEVICE 2ElectronicStimulator	PREDICATE DEVICE 3Pulserelief
	2-10, IEC60601-1-2safety standards	10, IEC60601-1-2 safetystandards
EMC	Comply with IEC 60601-1-2	Comply with IEC 60601-1-2	Unknown	IEC 60601-1-2
Sterility	N/A	N/A	N/A	N/A

Reference Devices Summary:

Reference device K090198:

The material of electrode pad in contact with patient is identical to that material cleared under K090198 JIAJIAN self-adhensive electrode, the subject device's biocompatibility of material contacted with patient was evaluated under K090198. Therefore, we chose K090198 as reference device to demonstrate biocompatibility safety.
Reference device K940954:
Similar to the subject device, Synaptic 3000 (cleared under K940954) in the market, which is also indicated for pain relief. The frequency band of the Synaptic 3000 is 250HZ~~60KHZ of which 250Hz~~1KHz is named as the TENS frequency band. The subject device's frequency band is within the Synaptic 3000's frequency band. All our TENS programs are within or very close to the conventional TENS band plus the high frequency TENS band in Synaptic 3000.

Review of Differences

Frequency range

Like many high frequency TENS comparable devices in the market, high frequency pulses from the RelieforMe TENS/EMS Device Model UPK-GE01 are used in bursts outputted with lower frequencies similar to the conventional TENS' frequencies. This way is equivalent to TENS with the wider pulse (burst in high frequency TENS case). The advantages of high frequency TENS include more comfortable sensation, deeper penetration to relieve deeper pain, and using less current or power. One of the TENS programs for the RelieforMe TENS/EMS Device Model UPK-GE01 uses the high TENS band in the same way that is equivalent to use a wider pulse (burst in our case) with conventional TENS frequency. This difference doesn't raise new questions of safety and effectiveness.

Pulses per burst

The burst of subject device contains more pulses than the predicate devices due to the higher frequency used. Higher frequency normally can penetrate deeper into the body to have better stimulation on the nerve trunk

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to relieve deeper pain. The pain relief treatment is as safe and effective as the predicate device. This difference doesn't raise new questions of safety and effectiveness.

Pulses per second

The subject device has more bursts per second than Predicate Device III to eliminate the potential stimulation resistance better due to the body may be used to fewer bursts. But the efficacy and safety are maintained. The way this burst TENS program is used is equivalent to the use of a wider pulse (burst in the case of the subject device) with conventional TENS frequency. The pain relief treatment is as safe and effective as the predicate device 3. This difference doesn't raise new questions of safety and effectiveness.

Burst duration

The subject device has lower burstion than Predicate Device III due to the higher frequencies used. It results in the similar energy applied. The way this burst TENS program is used is equivalent to the use of a wider pulse (burst in the case of the subject device) with conventional TENS frequency. The pain relief treatment is as safe and effective as the predicate device 3. This difference doesn't raise new questions of safety and effectiveness.

Duty Cycle

The duty cycles of the subject device are higher than those of the predicate devices due to the higher frequency pulse used. However, the subject device uses lower burst duration than the predicate device III. Therefore, the conclusion is the same as Note 5. This difference doesn't raise new questions of safety and effectiveness.

The RelieforMe TENS/EMS Device model UPK-GE01 has the same intended use and the same or similar technological characteristics and functionality as the predicate devices, and therefore is substantially equivalent to the predicate devices. The minor differences do not raise new questions of safety and effectiveness as compared to the predicate devices.

Maximum Phase Charge

The reason that the subject device's phase charge is higher than the predicate is because the allowed voltage is higher than predicate device's at 500. However, the subject device's still in the safety range. In addition, the negative phase charge and the positive phase charge are always balanced out. Therefore, the difference does not raise new questions of safety and effectiveness as compared to the predicate devices.

Phase Duration

The difference in phase duration between the subject device and the predicate device may or may not have different sensation to different people. It will not impact the safety and efficacy. The phase difference is due to difference in pulse ramp and ramp down time in the circuitry. Like many predicate devices, the subject device uses pulse with 0 ramp up and ramp down time. So the phase duration of the subject device is greater than the predicate device with nonzero ramp up and ramp down time, but the difference is not significant to have significant sensation. Therefore, the difference does not raise new questions of safety and effectiveness as compared to the predicate devices.

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9. Non-Clinical Performance Data

To demonstrate safety and effectiveness of RelieforMe TENS/EMS Device model UPK-GE01 and to show substantial equivalence to the predicate device, UMHEAL completed the following non-clinical tests. Results confirm that the design inputs and performance specifications for the device are met. The UPK-GE01 passed the testing in accordance with international standards shown below, supporting its safety and effectiveness, and its substantial equivalence to the predicate device:

Electrical safety testing per IEC 60601-1 – Passed
. Electromagnetic Disturbance (EMD) testing per IEC 60601-1-2 – Passed
Software verification and validation per FDA Guidance – results /conclusion
. Treatment Programs Performance Verification Testing
. Stability Verification Testing
. HFE Validation Testing
. FCC Testing
Transportation Testing per ASTM D4169 – Demonstrates package integrity maintained

10. Clinical Performance Data

Not applicable.

11. Statement of Substantial Equivalence

The RelieforMe TENS/EMS Device model UPK-GE01 has the same intended use as the predicate devices and the same or similar technological characteristics. The differences in technological characteristics do not raise new or different questions of safety and effectiveness. Performance testing has demonstrated the RelieforMe TENS/EMS Device model UPK-GE01 is as safe and effective as the predicate device. Therefore, the UPK-GE01 is substantially equivalent to the predicate device.

Regulation Number and Section

§ 890.5850 Powered muscle stimulator.

(a)
Identification. A powered muscle stimulator is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area.(b)
Classification. Class II (performance standards).