TENS (Mode 9~25)
To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back of the neck, arm, leg, and foot due to strain from exercise or normal household work activities by applying current to stimulate nerve.

Device Description

Health Expert Electronic Stimulator is a portable and adapter powered multifunctional device, offering both Transcutaneous Electronic Nerve Stimulator (TENS) and Powered Muscle Stimulator (PMS) qualities.

Health Expert Electronic Stimulator has 25 operation modes, which can give certain electrical pulse through 4 pcs of electrode pads placed on the skin to help users to enjoy body stimulation and 2 big electrode pads in Electrode Silicon Area for feet placed on the main unit to help users to enjoy sole stimulation.

The electronic stimulatory module has the operating elements of ON/OFF Switch, remote control ON/OFF key, Display screen, Heating adjust key, Mode Selection key and Intensity Modification keys.

The LCD display screen can show selected mode, output intensity of body and/or sole, and time remaining of an application mode.

The Heating adjust key can help user to select a temperature for warming sensation of the foot range 30 to 40 degree C, the superficial heating time is same as the treatment time you selected. The superficial heating and electrical stimulation can apply simultaneously or apply alternatively. The device is equipped with accessories of electrode wire, adapter, remote controller. The electrode wire is used to connect the main unit; the adapter wire is used to connect the adapter to the device.

The electrode pads, which are provided by Shenzhen Context Kang Technology Company Limited complying with the biocompatibility standards ISO 10993-5 (Cytotoxicity) and ISO 10993-10 (Irritation and Sensitization), are interchangeable.

AI/ML Overview

The provided text is a 510(k) Summary for the Health Expert Electronic Stimulator (model: AST-300L). It describes the device, its intended use, and a comparison to predicate devices to demonstrate substantial equivalence.

However, it does not describe:

Acceptance criteria in terms of performance metrics (e.g., sensitivity, specificity, accuracy) for a software or AI/ML device.
A study that proves the device meets such performance acceptance criteria through the analysis of a test set, expert adjudication, or reader studies.
Information regarding training sets, ground truth establishment methods for AI/ML, or the number of expert readers for an MRMC study.

The "Test Summary" section (Page 6) indicates various bench tests and standards compliance for electrical safety, electromagnetic compatibility, biocompatibility, usability, and software verification/validation. It also mentions a waveform test report. These are engineering and regulatory compliance tests, not a clinical or performance study of an AI/ML algorithm that would involve a test set, ground truth, or expert readers.

The conclusion of the document is based on substantial equivalence to predicate devices through technological characteristics and safety standards adherence, rather than demonstrating clinical performance of an AI/ML system.

Therefore, based solely on the provided text, the requested information on acceptance criteria and a study proving performance for an AI/ML device cannot be extracted. The device in question appears to be a Transcutaneous Electrical Nerve Stimulator (TENS) and Powered Muscle Stimulator (PMS), which is a hardware device for pain relief and muscle stimulation, not an AI/ML-driven diagnostic or therapeutic software device.

In summary, none of the specific points (1-9) related to AI/ML device acceptance criteria and performance study can be addressed from this document because it is for a physical medical device, not an AI/ML software.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

March 14, 2020

Shenzhen OSTO Technology Company Limited % Cassie Lee Manager Guangzhou GLOMED Biological Technology Co., Ltd. Room 2231, Building 1, Rui Feng Center, Kaichuang Road Huangpu District, Guangzhou Guangdong. 51006 China

Re: K190783

Trade/Device Name: Health Expert Electronic Stimulator (model: AST-300L) Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator For Pain Relief Regulatory Class: Class II Product Code: NUH, NGX Dated: February 7, 2020 Received: February 10, 2020

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.

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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 mediation-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, PhD Director DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K190783

Device Name

Health Expert Electronic Stimulator (model: AST-300L)

Indications for Use (Describe)

PMS (Mode 1~8)

It is intended to stimulate healthy muscles in order to improve and facilitate muscle performance.

TENS (Mode 9~25)
To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back of the neck, arm, leg, and foot due to strain from exercise or normal household work activities by applying current to stimulate nerve.

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

This summary of 510(K) safety and effectiveness information is being submitted in accordance with the requirement of 21 CFR 807.92.

1. Submitter's Information

510(k) Owner's Name: Shenzhen OSTO Technology Company Limited �
� Establishment Registration Number: 3011564440
Address: No.43 Longfeng Road, Xinsheng Community, Longgang Street, Longgang District, � Shenzhen City, Guangdong Province, China
Tel: +86-755-29769546 �
� Fax: +86-755-29769540
Contact Person: Li Yang (General Manger) �
Email: annaosto@163.com �

2. Application Correspondent:

� Contact Person: Ms. Cassie Lee
� Guangzhou GLOMED Biological Technology Co., Ltd.
Address: 2231, Building 1, Rui Feng Center, Kaichuang Road, HuangpuDistrict, Guangzhou, � Guangdong, China
� Tel: +86 20 8266 2446
Email: requlatory@glomed-info.com �

3. Subject Device Information

Health Expert Electronic Stimulator (model: AST-300L) � Trade Name:
Common Name: Transcutaneous electrical nerve stimulator for pain relief �
Stimulator, Nerve, Transcutaneous, Over-the-Counter � Classification name:
Neurology, Physical Medicine � Review Panel:
NUH, NGX Product Code: �
Regulation Class: ll �
Regulation Number: 882.5890, 890.5850 �

2. Predicate Device Information

Predicate Device 1:

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510(K) Number: K133929

Company Name: Shenzhen OSTO Technology Company Limited

Trade Name: Health Expert Electronic Stimulator

Model: AST-300C and AST-300D

Common Name: Transcutaneous electrical nerve stimulator for pain relief

Regulation Number: 882.5890, 890.5850

Regulatory Class: II

Product Code: NUH, NGX

Use: Over-The-Counter Use

Predicate Device 2:

510(K) Number: K160115 Company Name: Omron Healthcare, Inc. Trade Name: Heat Pain Pro Common Name: Transcutaneous electrical nerve stimulator for pain relief Regulation Number: 882.5890 Regulatory Class: II Product Code: NUH Use: Over-The-Counter Use

3. Device Description

Health Expert Electronic Stimulator has 25 operation modes, which can give certain electrical pulse through 4 pcs of electrode pads placed on the skin to help users to enjoy body stimulation

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and 2 big electrode pads in Electrode Silicon Area for feet placed on the main unit to help users to enjoy sole stimulation.

The electronic stimulatory module has the operating elements of ON/OFF Switch, remote control ON/OFF key, Display screen, Heating adjust key, Mode Selection key and Intensity Modification keys.

The LCD display screen can show selected mode, output intensity of body and/or sole, and time remaining of an application mode.

4. Intended Use / Indications for Use

PMS (Mode 1~8)

It is intended to stimulate healthy muscles in order to improve and facilitate muscle performance. TENS (Mode 9~25)

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.

5. Test Summary

Health Expert Electronic Stimulator has been evaluated the safety and performance by lab bench testing as following:

� Electrical safety test according to IEC 60601-1, IEC 60601-1-11 and IEC 60601-2-10 standards
� Electromagnetic compatibility test according to IEC 60601-1-2 standard
� Biocompatibility test according to ISO 10993-5 and ISO 10993-10 standards
� Usability test according to IEC 62366-1 standard
� Software verification and validation test according to the requirements of the FDA "Guidance for Pre-Market Submissions and for Software Contained in Medical Devices"

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� The waveform test report has also been conducted to verify the output specifications of the device according to Guidance for Transcutaneous Electrical Nerve Stimulator for Pain Relief Intended for Over the Counter Use and Guidance for Powered Muscle Stimulator for Muscle Conditioning

6. Comparison to predicate device and conclusion

The technological characteristics, features, specifications, materials, mode of operation, and intended use of Electronic Muscle 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.

Elements ofComparison	Subject Device	Predicate Device 1	Predicate Device 2	Remark
Device Name andModel	Health Expert ElectronicStimulatorModel: AST-300L	Health Expert ElectronicStimulatorModel: AST-300C andAST-300D	Heat Pain Pro	--
510(k) Number	K190783	K133929	K160115	--
Intended Use	PMS (Mode 1~~8)It is intended to stimulatehealthy muscles in order toimprove and facilitatemuscle performance.TENS (Mode 9~~25)To be used for temporaryrelief of pain associatedwith sore and achingmuscles in the shoulder,waist, back, back of theneck, arm, leg, and footdue to strain from exerciseor normal household workactivities by applying	PMS (Mode 1~~8)It is intended to stimulatehealthy muscles in orderto improve and facilitatemuscle performance.TENS (Mode 9~~25)To be used for temporaryrelief of pain associatedwith sore and achingmuscles in the shoulder,waist, back, back of theneck, arm, leg, and footdue to strain from exerciseor normal household workactivities by applying	The Heat Pain Proisintended for:The relief of painassociated with sore oraching, muscles of thelower back, arms, legs,shoulder, or foot due tostrain from exercise ornormal household workactivities.	SE
Elements ofComparison		Subject Device	Predicate Device 1	Predicate Device 2	Remark
		current to stimulate nerve.	current to stimulate nerve.
Power Source(s)		Adaptor Input:100-240Vac, 50-60Hz,0.1AOutput: 5Vdc, 2AUnit Input: 5Vdc, 2A	Adaptor Input:100-240Vac, 50-60Hz,0.1AOutput: 5Vdc, 1AUnit Input: 5Vdc, 1A	External supplyLithium-ion batteryAC adaptor/Rechargeable battery(Lithium Ion)	SENote 1
-Method of LineCurrent Isolation		Type BF Applied Part	Type BF Applied Part	Type BF Applied Part	SE
PatientLeakage	NC	AC: 54.5µA, DC: 0.5µA	AC: 54.5µA,DC: 0.5µA	1 µA	SE
Current	SFC	AC:120.0µA, DC: 0.6µA	AC:120.0µA, DC: 0.6µA	5.25µA max	SE
Average DCcurrent throughelectrodes whendevice is on butno pulses arebeing applied		< 0.01 µA	< 0.01 µA	0 (uA)	SE
Number ofOutput Channel		2	2	1	SE
Number of OutputModes		25	25	-3 Therapies(2 TENS with HEATcombination therapiesand 1TENS therapy)-9 TENS StimulationModes-2 Heat Level Settings	SE
Heating Setting		Adjustable	--	High and low	SENote 3
Heating		30-40°C	--	High: 43 °C maximum	SE
Elements ofComparison	Subject Device	Predicate Device 1	Predicate Device 2	Remark
temperature			Low: 42 °C maximum	Note 3
Output IntensityLevel	99 steps	99 steps	unknown	SE
Synchronous orAlternating?	Synchronous	Synchronous	unknown	SE
Method ofChannel Isolation	Voltage TransformIsolation"Body+" and "Body-"buttons for body channel," Sole+" and "Sole-"buttons for feet channel	Voltage TransformIsolation"Body▼" and "Body▼"buttons for body channel," Sole ▲" and "Sole ▼ "buttons for feet channel	--	SE
RegulatedCurrent orRegulatedVoltage?	Voltage Control	Voltage Control	Regulated Current	SE
Software/Firmware/MicroprocessorControl?	Yes	Yes	Yes	SE
AutomaticOverload Trip	No	No	No	SE
AutomaticNo-Load Trip	No	No	Yes	SE
Automatic ShutOff	Yes	Yes	Yes	SE
User OverrideControl	Yes	Yes	Yes	SE
IndicatorDisplay	On/OffStatus	Yes	Yes	Yes	SE
Elements ofComparison		Subject Device	Predicate Device 1	Predicate Device 2	Remark
	LowBattery	No	No	Yes	SE
	Voltage/CurrentLevel	Yes	Yes	Yes	SE
Timer Range		25 to 60 min	25min	30 min	SENote 1
Weight		2.1Kg (Withoutaccessories)	2Kg (Without accessories)	Approx. 200g (incl.batteries)	SENote 2
Dimensions		429.2mm x 401mm x152.8mm	428mm x 428.8mm x185mm	71(W)x165(H)x30.5(D)mm	SENote 2
Housing Materialsand Construction		Main unit: ABS plastic	Main unit: ABS plastic	Unknown	SE
Waveform		Pulsed, symmetric,biphasic	Pulsed, symmetric,biphasic	biphasic	SE
Shape		Rectangular, withinterphase interval	Rectangular, withinterphase interval	Rectangular	SE
Maximum OutputVoltage		44V±10% @ 500Ω	44V±10% @ 500Ω	67.2 V @ 500Ω	SE
		80V±10% @ 2KΩ	80V±10% @ 2KΩ	85.6 V @ 2KΩ
		112V±10% @ 10KΩ	112V±20% @ 10KΩ	95.9 V @ 10KΩ
Maximum OutputCurrent		88mA±10% @ 500Ω	88mA±10% @ 500Ω	134.4 mA @ 500Ω	SE
		40mA±10% @ 2KΩ	40mA±10% @ 2KΩ	42.8 mA @ 2KΩ
		11.2mA±10% @ 10KΩ	11.2mA±10% @ 10KΩ	9.6 mA @ 10KΩ
Pulse Duration		120µs	120µs	96µs	SE
Pulse frequency		77.3Hz	77.3Hz	1-20.13Hz	SE
Elements ofComparison	Subject Device	Predicate Device 1	Predicate Device 2	Remark
Net Charge (perpulse)	0µC @ 500ΩMethod: Balancedwaveform	0µC @ 500ΩMethod: Balancedwaveform	0µC @ 500ΩMethod: Balancedwaveform	SE
Maximum PhaseCharge	10.56μC @ 500Ω	12.78μC @ 500Ω	4.3 µC @ 500Ω	SE
MaximumAverage Current	1.63mA @ 500Ω	0.968mA @ 500Ω	8.43 mA @ 500Ω	SE
Maximum CurrentDensity(r.m.s )	0.0326mA/cm² @ 500Ω	0.235mA/cm2 @500Ω	0.08 mA/cm2 @500Ω	SENote 1
MaximumAverage PowerDensity	0.0000266mW/cm² @500Ω	1.38mW/cm² @ 500Ω	5.219E-09W/cm² @500Ω	SENote 1
ON Time	240 us	240 us	3.00s	SENote 1
OFF Time	12700 us	12700 us	0.10s	SENote 1
Environment foroperating	Temperature: 5 ~ 45° CHumidity: 20 ~ 65% RH	Temperature: 5 ~ 45°CHumidity: 20 ~ 65% RH	Temperature: 10 to 40°CHumidity: 30 to 80 %RH	SE
Environment forstorage	Temperature: 0 ~ 45°C,Humidity: 10 ~ 90% RHElectrode Pad: 10~20°C	Temperature: 0 ~ 45°C,Humidity: 10 ~ 90% RHElectrode Pad: 10~20°C	Temperature: 0 to 40°CHumidity: 30 to 80 %RH	SE
Biocompatibility	All user directly contactingmaterials are compliancewith ISO10993-5 andISO10993-10requirements.	All user directly contactingmaterials are compliancewith ISO10993-5 andISO10993-10requirements.	All user directlycontacting materials arecompliance withISO10993-5 andISO10993-10	SE
Elements ofComparison	Subject Device	Predicate Device 1	Predicate Device 2	Remark
			requirements.
Electrical Safety	Comply with IEC 60601-1and IEC 60601-2-10	Comply with IEC 60601-1and IEC 60601-2-10	ES60601-1,IEC60601-1-2,IEC60601-2-10	SE
EMC	Comply with IEC 60601-1-2	Comply with IEC60601-1-2	Comply with IEC60601-1-2	SE

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Comparison in Detail(s):

Note 1:

Although the "Power Source", "Maximum Output Current", ""Maximum Phase Charge", "Maximum Average Current", "Maximum Current Density", "Maximum Average Power Density" and "time range" are a little different from the predicate device, but it is complying with the IEC 60601-1 and IEC 60601-1-2 requirements. Therefore, the differences will not raise any safety or effectiveness issue.

Note 2:

Although the "Weight" and "Dimensions" are a little different from the predicate device, but the differences will not raise any safety or effectiveness issue.

Note 3:

Although the "Heating Setting" and "Heating temperature" are a little different from the predicate device, but it is complying with the IEC 60601-1 requirements. Therefore, the differences will not raise any safety or effectiveness issue.

Finial Conclusion:

The subject devices "Health Expert Electronic Stimulator, model AST-300L" are Substantial Equivalent to the predicate device K133929 and K160115.

8. Date of the summary prepared: March 12, 2020

Regulation Number and Section

§ 882.5890 Transcutaneous electrical nerve stimulator for pain relief.

(a)
Identification. A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain.(b)
Classification. Class II (performance standards).