(88 days)
Not Found
No
The description details a standard TENS/PMS device with heating functionality and manual controls. There is no mention of adaptive algorithms, data analysis, or any features indicative of AI/ML.
Yes
The device is described as offering Transcutaneous Electronic Nerve Stimulator (TENS) and Powered Muscle Stimulator (PMS) functions, which are used for temporary pain relief and muscle performance, both of which are therapeutic applications. It also provides heating for temporary relief of minor aches and pains.
No
Explanation: The device is intended for muscle stimulation and pain relief, not for diagnosing medical conditions.
No
The device description clearly states it is a "portable and adapter powered multifunctional device" with a "main unit," "electrode Pad," "foot conductive area," "heating belt," "operating elements," and a "remote controller." These are all hardware components, indicating it is not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes stimulating muscles for performance improvement, temporary pain relief, and temporary relief of minor aches and pains. These are all therapeutic or physical therapy applications, not diagnostic testing performed on samples taken from the body.
- Device Description: The description details a device that applies electrical pulses and heat to the body. It does not mention any components or functions related to analyzing biological samples (like blood, urine, tissue, etc.).
- Lack of IVD Characteristics: There is no mention of analyzing samples, detecting biomarkers, or providing diagnostic information about a disease or condition.
IVD devices are specifically designed to perform tests on samples from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device does not fit that description.
N/A
Intended Use / Indications for Use
PMS (mode 1~3): It is intended to stimulate healthy muscles in order to improve and facilitate muscle performance.
TENS (mode 4-6): To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, back of the neck, arm, leg, and foot due to strain from exercise or normal household work activities by applying current to stimulate nerve.
Heating: This function is designed to be used for temporary relief of minor aches and pains.
Product codes
NUH, NGX, IRT
Device Description
Ems Foot Stimulator is a portable and adapter powered multifunctional device, offering both Transcutaneous Electronic Nerve Stimulator (TENS), Powered Muscle Stimulator (PMS) and heating qualities.
Ems Foot Stimulator has 6 modes (PMS mode 13, TENS mode 46), which can give certain electrical pulse through 6 pcs of electrode Pad placed on the body to help users to enjoy body stimulation. There are 2 big electrode pads in foot conductive area for feet placed on the main unit to help users to enjoy sole stimulation. And a heating belt can provide heating treatment on waist area.
The main unit has the operating elements of Power on/off switch, ON/OFF Switch, Display screen, 2 Mode Selection keys, 2 Intensity Selection keys and a time setting key.
The LCD display screen can show selected mode, output intensity of body and sole, heating level and time remaining of an application mode.
The remote controller has a ON/OFF Switch to control the EMS/ TENS treatment, a ON/OFF switch to control heating treatment, 2 mode selection keys, 2 intensity selection keys, 2 heating adjust keys and a time setting key.
The heating belt and foot conductive pad can only warm the waist and foot rang 30 to 41 ˚C The Heating adjust keys on remote controller can help user to adjust the temperature for warming the waist and foot simultaneously. The heating and stimulation can be applied simultaneously.
There are 4 models, model HK701, HK701A, and HK701C, all the four models include a main unit and many accessories. The main unit of the four models are the same, the difference is only the accessories included in the package, so the function is a little different. Model difference is as below:
| Item | HK701 | HK701A | HK701B | HK701C |
|---|---|---|---|---|
| Function | Stimulation on foot and body, heating on foot and waist. | Stimulation on foot, heating on foot. | Stimulation on foot, heating on waist. | Stimulation on foot and body, heating on foot. |
| Accessories. | 3 pairs of electrode pads, a heating belt, an adapter, 2 electrode wire, a remote controller. | An adapter, a remote controller. | A heating belt, an adapter, a remote controller. | 3 pairs of electrode pads, an adapter, 2 electrode wire, a remote controller. |
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
shoulder, waist, back, back of the neck, arm, leg, and foot.
Indicated Patient Age Range
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Nonclinical test performed:
-
Biocompatibility testing: The biocompatibility evaluation for the Ems Foot Stimulator was conducted in accordance with "Use of International SO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" as recognized by FDA. The biocompatibility testing included the following tests: Cytotoxicity, Sensitization, Irritation. According to the test results, the subject device is biocompatible for its intended use. And it is complied with biocompatibility standards ISO 10993-5 (Cytotoxicity) and ISO 10993-10 Irritation and Sensitization).
-
Electrical safety and electromagnetic compatibility (EMC): Electrical safety and EMC testing were conducted on the Ems Foot Stimulator, the device complies with the IEC 60601-1, IEC 60601-1-11, and IEC 60601-2-10 standards for safety and the IEC 60601-1-2 standard for EMC.
-
Usability Testing: Usability testing were conducted on the Ems Foot Stimulator, the device complies with IEC 62366-1 and IEC 60601-1-6.
-
Software Verification and Validation Testing: Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "moderate" level of concern, since a malfunction of, or a latent design flaw in, the Software Device leads to an erroneous diagnosis or a delay in delivery of appropriate medical care that would likely lead to Minor Injury.
Clinical performance testing performed:
No clinical study was performed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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July 29, 2022
Guangzhou Hua Kai Electronic Technology Co., Ltd. % Cassie Lee Official Correspondent 2231, Building 1, Rui Feng Center, Kaichuang Road, Huangpu District Guangzhou, Guangdong 510000 China
Re: K221251
Trade/Device Name: Ems Foot Stimulator (model: HK701A, HK701A, HK701B, HK701C) Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator For Pain Relief Regulatory Class: Class II Product Code: NUH, NGX, IRT Dated: April 21, 2022 Received: May 2, 2022
Dear Cassie Lee:
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
1
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,
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
2
Indications for Use
510(k) Number (if known) K220251
Device Name
Ems Foot Stimulator (model: HK701, HK701A, HK701B, HK701C)
Indications for Use (Describe)
PMS (mode 1~3): It is intended to stimulate healthy muscles in order to improve and facilitate muscle performance.
TENS (mode 4-6): To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, back of the neck, arm, leg, and foot due to strain from exercise or normal household work activities by applying current to stimulate nerve.
Heating: This function is designed to be used for temporary relief of minor aches and pains.
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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3
Chapter 6. 510(k) Summary
510(k) Summary
This summary of 510(K) safety and effectiveness information is being submitted in accordance with the requirement of 21 CFR 807.92.
Submitter's Information 1.
Name: Guangzhou Hua Kai Electronic Technology Co., Ltd. Address: 4th Floor, Building 8, No.39 Bi Gang Road, Donggu Street, Huangpu District Guangzhou, Guangdong, 510730, CHINA Contact name: Cao Ke Title: Manager Tel: +86-020-82061985 E-mail: 252288906@qq.com Email: annaosto@163.com
Application Correspondent: 2.
Contact Person: Ms. Cassie Lee Guangzhou GLOMED Biological Technology Co., Ltd. Address: 2231, Building 1, Rui Feng Center, Kaichuang Road, Huangpu District, Guangzhou, Guangdong, China Tel: +86 20 8266 2446 Email: regulatory@glomed-info.com
Subject Device Information 3.
Common Name: Transcutaneous electrical nerve stimulator for pain relief Trade Name: Ems Foot Stimulator Classification Name: Stimulator, Nerve, Transcutaneous, Over-the-Counter Model: HK-701, HK-701A, HK-701B, HK-701C Regulatory Class: II Product Code: NUH, NGX, IRT Regulation Number: 882.5890, 890.5850, 890.5740
2. Predicate Device Information
Predicate Device 1:
510(K) Number: K203574
Report by
4
Company Name: HIVOX BIOTEK INC.
Address: 5F., No. 123, Xingde Rd., Sanchong Dist., New Taipei City 24158, Taiwan, R.O.C.
Trade Name: Health Expert Electronic Stimulator
Model: EM59-1, EM59-2
Requlation Number: 882.5890, 890.5850, 890.5740
Requlatory Class: II
Product Code: NUH, NGX, IRT
Predicate Device 2:
510(K) Number: K190783 Company Name: Shenzhen OSTO Technology Company Limited Address: No.43 Longfeng Road, Xinsheng Community, Longgang Street, Longgang District, Shenzhen City, Guangdong Province, China Trade Name: Health Expert Electronic Stimulator Model: AST-300L Common Name: Electronic Stimulator Regulation Number: 882.5890 Requlatory Class: II Product Code: NUH, NGX
3. Device Description
Ems Foot Stimulator is a portable and adapter powered multifunctional device, offering both Transcutaneous Electronic Nerve Stimulator (TENS), Powered Muscle Stimulator (PMS) and heating qualities.
Ems Foot Stimulator has 6 modes (PMS mode 13, TENS mode 46), which can give certain electrical pulse through 6 pcs of electrode Pad placed on the body to help users to enjoy body stimulation. There are 2 big electrode pads in foot conductive area for feet placed on the main unit to help users to enjoy sole stimulation. And a heating belt can provide heating treatment on waist area.
The main unit has the operating elements of Power on/off switch, ON/OFF Switch, Display screen, 2 Mode Selection keys, 2 Intensity Selection keys and a time setting key.
The LCD display screen can show selected mode, output intensity of body and sole, heating level and time remaining of an application mode.
5
| Sponsor: | Guangzhou Hua Kai Electronic Technology Co., Ltd. |
|---|---|
| Subject Device: | EMS Foot Massager |
| File No.: | 510(k) submission report (V1.0) |
The remote controller has a ON/OFF Switch to control the EMS/ TENS treatment, a ON/OFF switch to control heating treatment, 2 mode selection keys, 2 intensity selection keys, 2 heating adjust keys and a time setting key.
The heating belt and foot conductive pad can only warm the waist and foot rang 30 to 41 ˚C The Heating adjust keys on remote controller can help user to adjust the temperature for warming the waist and foot simultaneously. The heating time is same as the treatment time you selected. The heating and stimulation can be applied simultaneously.
There are 4 models, model HK701, HK701A, and HK701C, all the four models include a main unit and many accessories. The main unit of the four models are the same, the difference is only the accessories included in the package, so the function is a little different. Model difference is as below:
| Item | HK701 | HK701A | HK701B | HK701C |
|---|---|---|---|---|
| Function | Stimulation on | |||
| foot and body, | ||||
| heating on foot | ||||
| and waist. | Stimulation on | |||
| foot, heating on | ||||
| foot. | Stimulation on | |||
| foot, heating on | ||||
| waist. | Stimulation on | |||
| foot and body, | ||||
| heating on foot. | ||||
| Accessories. | 3 pairs of | |||
| electrode pads, | ||||
| a heating belt, | ||||
| an adapter, 2 | ||||
| electrode wire, | ||||
| a remote | ||||
| controller. | An adapter, a | |||
| remote | ||||
| controller. | A heating belt, | |||
| an adapter, | ||||
| a remote | ||||
| controller. | 3 pairs of | |||
| electrode pads, | ||||
| an adapter, 2 | ||||
| electrode wire, a | ||||
| remote controller. |
4. Intended Use / Indications for Use
PMS (mode 1~3): It is intended to stimulate healthy muscles in order to improve and facilitate muscle performance.
TENS (mode 4~6): To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, back of the neck, arm, leg, and foot due to strain from exercise or normal household work activities by applying current to stimulate nerve. Heating: This function is designed to be used for temporary relief of minor aches and pains.
5. Performance data and test summary
The following performance data were provided in support of the substantial equivalence determination.
Nonclinical test performed
- Biocompatibility testing
The biocompatibility evaluation for the Ems Foot Stimulator was conducted in accordance with "Use of International SO 10993-1, "Biological evaluation of medical devices -
6
| Sponsor: | Guangzhou Hua Kai Electronic Technology Co., Ltd. |
|---|---|
| Subject Device: | EMS Foot Massager |
| File No.: | 510(k) submission report (V1.0) |
Part 1: Evaluation and testing within a risk management process" as recognized by FDA. The biocompatibility testing included the following tests:
- . Cytotoxicity
- . Sensitization
- Irritation .
According to the test results, the subject device is biocompatible for its intended use. And it is complied with biocompatibility standards ISO 10993-5 (Cytotoxicity) and ISO 10993-10 Irritation and Sensitization).
- Electrical safety and electromagnetic compatibility (EMC)
Electrical safety and EMC testing were conducted on the Ems Foot Stimulator, the device complies with the IEC 60601-1, IEC 60601-1-11, and IEC 60601-2-10 standards for safety and the IEC 60601-1-2 standard for EMC.
- Usability Testing
Usability testing were conducted on the Ems Foot Stimulator, the device complies with IEC 62366-1 and IEC 60601-1-6.
- Software Verification and Validation Testing
Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "moderate" level of concern, since a malfunction of, or a latent design flaw in, the Software Device lead s to an erroneous diagnosis or a delay in delivery of appropriate medical care that would likely lead to Minor Injury.
Clinical performance testing performed
No clinical study was performed.
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6. Comparison to predicate device and conclusion
The technological characteristics, features, specifications, materials, mode of operation, and intended use of Ems Foot Stimulator is substantially equivalent to the predicate devices quoted above.
The differences between the subject device and predicate devices do not raise new issues of safety or effectiveness.
Comparison in Detail(s):
| Elements of
Comparison | Subject Device | Primary Predicate
Device | Secondary
Predicate
Device | Remark | |
|--------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------|-------------------|
| Device Name
and Model | Ems Foot Stimulator
Model: 701, 701A,
701B, 701C | HIVOX OTC Electrical
Stimulator
Model: EM59-1, EM59-2 | Health Expert
Electronic
Stimulator
Model: AST-300L | -- | |
| 510(k) Number | Applying | K203574 | K190783 | -- | |
| Product Code | NUH, NGX, IRT | NUH, NGX, IRT | NUH, NGX | Same | |
| Intended Use | PMS (mode 13): It is6): To
intended to stimulate
healthy muscles in
order to improve and
facilitate muscle
performance.
TENS (mode 4
be used for temporary
relief of pain
associated with sore
and aching muscles in
the shoulder, waist,
back, back of the neck,
arm, leg, and foot due
to strain from exercise
or normal household
work activities by
applying current to
stimulate nerve.
Heating: This function
is designed to be used
for temporary relief of
minor aches and
pains. | HIVOX OTC Electrical
Stimulator, EM59-2
TENS: This function is
designated to be used for
temporary relief of pain
associated with sore and
aching muscles in the
shoulder, waist, back,
upper extremities (arm)
and lower extremities (leg)
due to strain from
exercise or normal
household
work activities.
EMS: This function is
designed to be used for
stimulating healthy
muscles in order to
improve and facilitate
muscle
performance.
SH: This function is
designed to be used for
temporary relief of minor
aches and pains. | PMS (Mode 18)25)
It is intended to
stimulate healthy
muscles in order to
improve and
facilitate muscle
performance.
TENS (Mode 9
To be used for
temporary relief of
pain associated with
sore and aching
muscles in the
shoulder, waist,
back, back of the
neck, arm, leg, and
foot due to strain
from exercise or
normal household
work activities by
applying current to
stimulate nerve. | Same | |
| Elements of
Comparison | | Subject Device | Primary Predicate
Device | Secondary
Predicate
Device | Remark |
| Power
Source(s) | | Adaptor Input: 100-
240Vac, 50-60Hz,
0.1A
Output: DC12V-3A | Rechargeable battery | Adaptor Input:
100-240Vac, 50-
60Hz,
0.1A
Output: 5Vdc, 2A
Unit Input: 5Vdc, 2A | Similar
Note 1 |
| Function and
Design | | Electrical stimulation
and heat | Electrical stimulation and
heat | Electrical
stimulation and heat | Same |
| Heating Setting | | Adjustable | Low and high | Adjustable | Same |
| Output Patterns | | ● Electrical
stimulation only
● Heat only
● Electrical
stimulation + heat
simultaneously | ● Electrical stimulation
only
● Heat only
● Electrical stimulation
- heat
simultaneously | Not public available | Same |
| Method of Line
Current
Isolation | | Type BF Applied Part | N/A (internal power
source) | Type BF Applied
Part | Same |
| Patient
Leakage
Current | NC
SFC | AC: 54.5μA, DC:
0.5μA
AC:120.0μA, DC:
0.6μA | 6.0 μΑ
5.6 μΑ | AC: 54.5μA, DC:
0.5μA
AC:120.0μA, DC:
0.6μA | Same |
| Average DC
current through
electrodes when
device is on but
no pulses are
being applied | |