← Product Code [IPF](/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IPF) · K192733 # RelieforMe TENS/EMS Device Model UPK-GE01 (K192733) _Umeheal , Ltd. · IPF · Dec 23, 2019 · Physical Medicine · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IPF/K192733 ## Device Facts - **Applicant:** Umeheal , Ltd. - **Product Code:** [IPF](/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IPF.md) - **Decision Date:** Dec 23, 2019 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 890.5850 - **Device Class:** Class 2 - **Review Panel:** Physical Medicine - **Attributes:** Therapeutic ## Indications for Use TENS: 1. 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. 2. It is also intended for symptomatic relief and management of chronic, intractable pain associated with arthritis. EMS: 3. 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. 4. 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 Story RelieforMe UPK-GE01 is a TENS/EMS combination device for pain relief and muscle conditioning. It uses intelligent software-controlled programs to deliver electrical pulses via skin electrodes. Input: user-selected treatment program; Output: electrical stimulation pulses. Used by adults 18+ in home or clinic settings. Device features include automatic overload/no-load trip and automatic shut-off. Healthcare providers or patients use the device to manage pain or improve muscle function. Benefits include non-pharmacological pain relief, muscle strengthening, and prevention of atrophy/venous thrombosis. ## Clinical Evidence No clinical data. Bench testing only, including electrical safety (IEC 60601-1), electromagnetic disturbance (IEC 60601-1-2), software verification/validation, treatment program performance, stability, HFE validation, FCC testing, and transportation testing (ASTM D4169). ## Technological Characteristics Powered by Lithium Ion Polymer battery. Provides TENS (1-1200Hz) and EMS (1-100Hz) stimulation. Max output 61V-65V depending on load. Biocompatibility per ISO 10993-5/10. Electrical safety per IEC 60601-1, IEC 60601-2-10, IEC 60601-1-2. Features microprocessor control with automatic overload/no-load trip and auto-shutoff. Single output channel. ## Regulatory 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. ## Predicate Devices - Mini TENS DEVICE (Model KRES102), TENS & EMS DEVICE (Model KRES100B) ([K172933](/device/K172933.md)) - Electronic Pulse Stimulator ([K162517](/device/K162517.md)) - Pulserelief ([K151035](/device/K151035.md)) ## Reference Devices - JIAJIAN self-adhesive electrode ([K090198](/device/K090198.md)) - SYNAPTIC 3000 ([K940954](/device/K940954.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services seal on the left and the FDA acronym and name on the right. The FDA acronym is in a blue square, and the full name "U.S. Food & Drug Administration" is in blue text. 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. {1}------------------------------------------------ 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 {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K192733 Device Name RelieforMe TENS/EMS Device Model UPK-GE01 # Indications for Use (Describe) TENS: 1. 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. 2. It is also intended for symptomatic relief and management of chronic, intractable pain associated with arthritis. EMS: 3. 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. 4. 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) ### 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}------------------------------------------------ # 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. {4}------------------------------------------------ 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: 1. 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. 2. It is also intended for symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis. EMS: 3. 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. 4. 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 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. {5}------------------------------------------------ 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 {6}------------------------------------------------ | Attribute | SUBJECT DEVICE | PREDICATE DEVICE 1 | PREDICATE DEVICE 2 | PREDICATE DEVICE 3 | |----------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------| | | RelieforMe TENS & EMS
DEVICE | Mini TENS DEVICE
(Model KRES102), TENS
& EMS DEVICE | Electronic
Stimulator | Pulse
Pulserelief | | | Model:UPK-GE01 | Model KRES100B | | | | | 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. | abdomen, and leg due to
strain from exercise or
normal household and
work activities. | muscle performance.
To be used for the
improvement of
muscle tone and
firmness, and for
strengthening
muscles in the arms,
abdomen, legs, and
buttocks. Not
intended for use in
any therapy or for the
treatment of any
medical conditions or
diseases. It is also
intended to
temporarily increase
local blood circulation
in the healthy
muscles of lower
extremities. | | | | 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. | EMS: It is 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 | Heating Mode
Temporary relief of
minor aches and
pains. | | | Power Sources | Lithium Ion Polymer
battery | 3.0V210mAh Button
lithium manganese
battery | Rechargeable battery | Li-ion 3.7V 500mAh | | Software/Firmware
are/Microprocessor
control | Yes | Yes | Yes | Yes | | Automatic
Overload Trip | Yes | Yes | Unknown | Yes | | Automatic No- load
Trip | Yes | Yes | Unknown | Yes | | Automatic Shut Off | Yes | Yes | Unknown | Yes | | Maximum
Output Voltage | 61V ± 20%@ 500Ω
65V ± 20%@ 2kΩ
65V± 20%@ 10kΩ | 28.2V @500Ω
48.4V @ 2kΩ
82V @ 10kΩ | @ 500Ω:
Mode 1: This mode
cycles
the following modes
Mode 2: 36.4V ± 20%
Mode 3: 47.6V ± 20%
Mode 4: 57.6 V± 20% | Both TENS & EMS:
31V ± 20% @ 500Ω
69V ± 20% @ 2kΩ
70V ± 20% @ 10kΩ | {7}------------------------------------------------ | Attribute | SUBJECT DEVICE | PREDICATE DEVICE 1 | PREDICATE DEVICE 2 | PREDICATE DEVICE 3 | |---------------------------|-------------------------------------------------------------|-----------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------| | | RelieforMe TENS & EMS
DEVICE | Mini TENS DEVICE
(Model KRES102), TENS
& EMS DEVICE | Electronic
Stimulator | 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 mode
cycles
the following modes
Mode 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 mode
cycles
the following modes
Mode 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 output
Current | 122mA ± 20%@ 500Ω
32.5mA ± 20%@ 2kΩ
6.5mA ± 20%@ 10kΩ | 56.4mA@500Ω
24.2mA @ 2kΩ
8.2mA@10kΩ | @ 500Ω:
Mode 1: This mode
cycles
the following modes
Mode 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% @ 500Ω
34mA± 20% @ 2kΩ
7mA± 20% @ 10kΩ | {8}------------------------------------------------ | Attribute | SUBJECT DEVICE
RelieforMe TENS & EMS
DEVICE
Model:UPK-GE01 | PREDICATE DEVICE 1
Mini TENS DEVICE
(Model KRES102), TENS
& EMS DEVICE
Model KRES100B | PREDICATE DEVICE 2
Electronic
Stimulator
Pulse | PREDICATE DEVICE 3
Pulserelief | |-----------------|---------------------------------------------------------------------|---------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------| | | | | @ 2kΩ:
Mode 1: This mode
cycles
the following modes
Mode 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 mode
cycles
the following modes
Mode 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:
1~1200HZ
For EMS:
1~100HZ | 1~117.3Hz | Mode 1: This mode
cycles
the following modes
Mode 2: 62.5HZ
Mode 3: 12.8~54.3HZ
Mode 4: 1.19HZ
Mode 5: 104.1HZ
Mode 6: 104.1HZ | For TENS:
1~100HZ
For EMS:
40 ~ 65 HZ | {9}------------------------------------------------ | Attribute | SUBJECT DEVICE
RelieforMe TENS & EMS
DEVICE
Model:UPK-GE01 | PREDICATE DEVICE 1
Mini TENS DEVICE
(Model KRES102), TENS
& EMS DEVICE
Model KRES100B | PREDICATE DEVICE 2
Electronic
Stimulator | PREDICATE DEVICE 3
Pulserelief | |-------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------| | Pulse width range | TENS:4~300µs;
EMS:250~400µs | TENS:96~260µs;
EMS:150~260µs sss | Unknown | TENS: 60 ~ 350 µs
EMS: 150 ~ 350 µs | | Patient Leakage
Current | <1uA | N/A | N/A | <10uA | | Method of Channel
Isolation | N/A
(1 output channel) | Unknown | Unknown | N/A
(1 output channel) | | Maximum Phase
Charge (μC) | TENS :
36.6μC @ 500Ω
9.75μC @ 2kΩ
1.95μC @ 10kΩ
EMS :
48.8μC @ 500Ω
13.0μC @ 2kΩ
2.6μC @ 10kΩ | N/A | @ 500Ω:
Mode 1: This mode
cycles
the following modes
Mode 2: 14.6μC
Mode 3: 19.0μC
Mode 4: 23.0μC
Mode 5: 11.8μC
Mode 6: 11.8μC
Mode 7: 16.3µC
Mode 8: 9.6µC | TENS:
1.6~6.8μC@500Ω
EMS:
4.7~10.9μC@ 500Ω | | For interferential
modes only: - Beat
Frequency (Hz) | N/A | N/A | N/A | N/A | | For multiphasic
waveforms only: -
Symmetrical phases? | YES | Unknown | Unknown | YES | | Phase Duration | TENS:4~300μs
EMS:250~400μs | Unknown | Unknown | TENS:25~175µs
EMS: 75~175µs | | Biocompatibility | Compliant with
requirements of
ISO10993-5 and
ISO10993-10 standards | Compliant with
requirements of
ISO10993-5 and
ISO10993-10 standards | Unknown | Unknown | | Electrical Safety | Compliant with
requirements of
IEC60601-1, IEC60601- | Compliant with
requirements of
IEC60601-1, IEC60601-2- | Unknown | IEC 60601-1, IEC
60601-2-10, ISO10993-
5/10 | {10}------------------------------------------------ | Attribute | SUBJECT DEVICE
RelieforMe TENS & EMS
DEVICE
Model:UPK-GE01 | PREDICATE DEVICE 1
Mini TENS DEVICE
(Model KRES102), TENS
& EMS DEVICE
Model KRES100B | PREDICATE DEVICE 2
Electronic
Stimulator | PREDICATE DEVICE 3
Pulserelief | |-----------|---------------------------------------------------------------------|---------------------------------------------------------------------------------------------------|------------------------------------------------|-----------------------------------| | | 2-10, IEC60601-1-2
safety standards | 10, IEC60601-1-2 safety
standards | | | | 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 {11}------------------------------------------------ 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. {12}------------------------------------------------ ### 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. --- **Source:** [https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IPF/K192733](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IPF/K192733) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com