Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The description mentions "intelligent programs/software" and "intelligent use," but there is no explicit mention of AI, ML, or related concepts like neural networks, training data, or performance metrics typically associated with AI/ML devices. The performance studies listed are standard electrical safety, software validation, and usability testing, not AI/ML model performance evaluation.

Therapeutic

Yes
The device is described as a TENS/EMS combination device intended for temporary relief of pain and muscle stimulation for improved performance and recovery, which are therapeutic uses.

Diagnostic

No

The device is described as focusing on "pain relief, muscle strengthening and recovery features" through TENS and EMS treatment techniques. Its intended uses are for temporary relief of pain and muscle stimulation for performance and recovery, not for diagnosing medical conditions.

SaMD (Software as a Medical Device)

No

The device description explicitly states "RelieforMe TENS/EMS Device model UPK-GE01" and mentions electrical safety and electromagnetic disturbance testing, which are associated with hardware components, not software-only devices.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
Device Function: The RelieforMe TENS/EMS Device model UPK-GE01 is a Transcutaneous Electrical Nerve Stimulator (TENS) and Electrical Muscle Stimulator (EMS) device. It applies electrical stimulation to the body's surface for pain relief and muscle stimulation.
Intended Use: The intended uses described are for pain relief and muscle stimulation, which are direct applications to the body, not the analysis of in vitro specimens.

The device's function and intended use clearly fall outside the scope of In Vitro Diagnostics.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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:
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.

Product codes

IPF, GZJ, NUH

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).

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

shoulder, neck, back, waist, abdomen, lower extremities (legs), upper extremities (arms)

Indicated Patient Age Range

18 and older

Intended User / Care Setting

Over-The-Counter Use

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies

Non-Clinical Performance Data:

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.

Key Metrics

Not Found

Predicate Device(s)

K172933, K162517, K151035

Reference Device(s)

K090198, K940954

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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).

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.

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

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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.

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:

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 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

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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

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Attribute	SUBJECT DEVICE	PREDICATE DEVICE 1	PREDICATE DEVICE 2
	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

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| 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:
11200HZ
For EMS:
1100HZ | 1117.3Hz | Mode 1: This mode
cycles
the following modes
Mode 2: 62.5HZ
Mode 3: 12.854.3HZ
Mode 4: 1.19HZ
Mode 5: 104.1HZ
Mode 6: 104.1HZ | For TENS:
1~100HZ
For EMS:
40 ~ 65 HZ |

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| 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:4300µs;
EMS:250400µs | TENS:96260µs;
EMS:150260µs sss | Unknown | TENS: 60 ~ 350 µs
EMS: 150 ~ 350 µs |
| Patient Leakage
Current |