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.

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, Display screen, 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 device is equipped with accessories of electrode wire, adapter, remote controller. The electrode wire is used to connect the pads to 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) Pre-Market Notification for a medical device, the "Health Expert Electronic Stimulator." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel safety and effectiveness through extensive clinical trials.

Therefore, the document does not contain the type of AI-specific acceptance criteria or detailed study information typically found for novel AI/ML medical devices. The device in question is an electronic stimulator, not an AI/ML-driven diagnostic or therapeutic device.

The "Test Summary" and "Comparison to predicate device" sections outline the types of testing and comparisons performed for this device. These are primarily engineering, electrical, and biocompatibility tests, alongside a comparison of technical specifications to a previously cleared device.

Specifically, the document does not provide information on:

AI-specific Acceptance Criteria: The device is not an AI/ML product.
Study Proving Device Meets Acceptance Criteria for AI: No AI-specific studies were conducted because the device is not AI.
Sample size for test set (for AI): Not applicable.
Data provenance (for AI): Not applicable.
Number of experts for ground truth (for AI): Not applicable.
Qualifications of experts (for AI): Not applicable.
Adjudication method (for AI): Not applicable.
MRMC comparative effectiveness study for AI: Not applicable.
Standalone (algorithm-only) performance for AI: Not applicable.
Type of ground truth used (for AI): Not applicable.
Sample size for training set (for AI): Not applicable.
How ground truth for training set was established (for AI): Not applicable.

The "acceptance criteria" for this device are implicitly derived from the general and special controls for Class II medical devices, and the demonstrated substantial equivalence to the predicate device (K133929). This equivalence is shown through comparison of intended use, technical specifications, and compliance with relevant electrical safety, EMC, biocompatibility, usability, and software verification/validation standards.

Here's what the document does describe in terms of performance and testing:

1. Table of Acceptance Criteria (Implied by Equivalence) and Reported Device Performance:

The "Comparison to predicate device and conclusion" section (Pages 5-6) serves as the primary "performance" and "acceptance" comparison. The acceptance is based on demonstrating that the subject device's characteristics and performance are substantially equivalent to the predicate, and that any differences do not raise new safety or effectiveness issues.

Elements of Comparison (Implied Acceptance Criteria)	Subject Device Performance	Predicate Device Performance	Remark (Fulfillment of "Acceptance" - SE = Substantially Equivalent)
Intended Use (PMS & TENS)	PMS (Mode 1~~8): Stimulate healthy muscles for performance. TENS (Mode 9~~25): Temporary pain relief for sore/aching muscles due to strain.	PMS (Mode 1~~8): Stimulate healthy muscles for performance. TENS (Mode 9~~25): Temporary pain relief for sore/aching muscles due to strain.	SE
Power Source(s)	Adaptor Input: 100-240Vac, 50-60Hz, 0.1A; Output: 5Vdc, 1A; Unit Input: 5Vdc, 1A	Adaptor Input: 100-240Vac, 50-60Hz, 0.1A; Output: 5Vdc, 1A; Unit Input: 5Vdc, 1A	SE
Method of Line Current Isolation	Type BF Applied Part	Type BF Applied Part	SE
Patient Leakage Current	NC (Not specified numerically, implying compliance)	AC: 54.5μA, DC: 0.5μA	SE (implies within acceptable limits vs predicate)
SFC (Single Fault Condition) Leakage Current	NC (Not specified numerically, implying compliance)	AC: 120.0μA, DC: 0.6μA	SE (implies within acceptable limits vs predicate)
Avg DC current (device on, no pulses)	< 0.01μA	< 0.01μA	SE
Number of Output Channels	2	2	SE
Number of Output Modes	25	25	SE
Output Intensity Level	99 steps	99 steps	SE
Synchronous or Alternating?	Synchronous	Synchronous	SE
Method of Channel Isolation	Voltage Transform Isolation; "Body+" and "Body-" buttons for body channel, "Sole+" and "Sole-" buttons for feet channel	Voltage Transform Isolation; "Body ▼" and "Body▼" buttons for body channel, "Sole ▲" and "Sole ▼ " buttons for feet channel	SE
Regulated Current or Voltage?	Voltage Control	Voltage Control	SE
Software/Firmware/Microprocessor Control?	Yes	Yes	SE
Automatic Overload Trip	No	No	SE
Automatic No-Load Trip	No	No	SE
Automatic Shut Off	Yes	Yes	SE
User Override Control	Yes	Yes	SE
Indicator Display	On/Off Status, Low Battery, Voltage/Current Level	Yes (for Status, Voltage/Current), No (for Low Battery)	SE (minor display difference for low battery, considered not raising new safety/effectiveness)
Timer Range	25min	25min	SE
Weight	1.9Kg (Without accessories)	2Kg (Without accessories)	SE (Note 1: minor difference, no safety/effectiveness issue)
Dimensions	429.1mm x 426.6mm x 153.8mm	428mm x 428.8mm x 185mm	SE (Note 1: minor difference, no safety/effectiveness issue)
Housing Materials and Construction	Main unit: ABS plastic	Main unit: ABS plastic	SE
Waveform	Pulsed, symmetric, biphasic	Pulsed, symmetric, biphasic	SE
Shape	Rectangular, with interphase interval	Rectangular, with interphase interval	SE
Maximum Output Voltage	44V±10% @ 500Ω; 80V±10% @ 2KΩ; 112V±10% @ 10KΩ	44V±10% @ 500Ω; 80V±10% @ 2KΩ; 112V±20% @ 10KΩ	SE
Maximum Output Current	88mA±10% @ 500Ω; 40mA±10% @ 2KΩ; 11.2mA±10% @ 10KΩ	88mA±10% @ 500Ω; 40mA±10% @ 2KΩ; 11.2mA±10% @ 10KΩ	SE
Pulse Duration	120µs	120µs	SE
Pulse Frequency	77.3Hz	77.3Hz	SE
Net Charge (per pulse)	0µC @ 500Ω; Method: Balanced waveform	0µC @ 500Ω; Method: Balanced waveform	SE
Maximum Phase Charge	10.56µC @ 500Ω	12.78µC @ 500Ω	SE
Maximum Average Current	1.63mA @ 500Ω	0.968mA @ 500Ω	SE
Maximum Current Density (r.m.s)	0.0326mA/cm² @ 500Ω	0.235mA/cm² @500Ω	SE
Maximum Average Power Density	0.000651mW/cm² @ 500Ω	1.38mW/cm² @ 500Ω	SE
ON Time	0.6s	0.6s	SE
OFF Time	0.6s	0.6s	SE
Environment for operating	Temperature: 5 ~ 45°C; Humidity: 20 ~ 65% RH	Temperature: 5 ~ 45°C; Humidity: 20 ~ 65% RH	SE
Environment for storage	Temperature: 0 ~ 45°C, Humidity: 10 ~ 90% RH; Electrode Pad: 10~20°C	Temperature: 0 ~ 45°C, Humidity: 10 ~ 90% RH; Electrode Pad: 10~20°C	SE
Biocompatibility	All user directly contacting materials are compliant with ISO10993-5 and ISO10993-10 requirements.	All user directly contacting materials are compliant with ISO10993-5 and ISO10993-10 requirements.	SE
Electrical Safety	Comply with IEC 60601-1 and IEC 60601-2-10	Comply with IEC 60601-1 and IEC 60601-2-10	SE
EMC	Comply with IEC 60601-1-2	Comply with IEC 60601-1-2	SE

2. Sample size used for the test set and the data provenance:

This information is not provided in terms of patient data. The "test set" refers to the specific physical devices and components tested for laboratory and engineering compliance (e.g., electrical safety, EMC, biocompatibility).
Data Provenance: The tests are indicated to be "lab bench testing" (P. 4, section 6) based on international standards (IEC, ISO). The country of manufacture is China, and the submitting entity is Shenzhen OSTO Technology Company Limited. There is no mention of patient data or clinical studies in a retrospective or prospective sense.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This concept of "experts establishing ground truth" is not applicable in the context of this 510(k) submission, as it relates to AI/ML or diagnostic performance based on patient data.
The device's performance is verified against engineering standards and specifications, likely by trained laboratory personnel.

4. Adjudication method for the test set:

Not applicable, as this refers to a process typically used in clinical studies or for establishing ground truth in AI/ML performance evaluation, which is not relevant here.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This device is not an AI-assisted diagnostic or therapeutic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable, as this device does not utilize an algorithm in the AI/ML sense to provide standalone diagnostic or therapeutic performance.

7. The type of ground truth used:

For this device, "ground truth" equates to the established engineering specifications and limits for electrical stimulation devices, as well as the requirements of relevant international standards (e.g., IEC 60601 series for electrical safety and EMC, ISO 10993 series for biocompatibility). The tests confirm the device operates within these predefined, acceptable parameters.

8. The sample size for the training set:

Not applicable, as there is no AI/ML training set involved for this device.

9. How the ground truth for the training set was established:

Not applicable, as there is no AI/ML training set involved for this device.

Summary

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Image /page/0/Picture/0 description: The image shows 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.

December 12, 2019

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

Re: K190673

Trade/Device Name: Health Expert Electronic Stimulator, Models AST-300F, AST-300H, AST-300J Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator For Pain Relief Regulatory Class: Class II Product Code: NUH, NGX Dated: September 7, 2019 Received: September 13, 2019

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

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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 D. 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

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Indications for Use

510(k) Number (if known) K190673

Device Name

Health Expert Electronic Stimulator (model: AST-300F, AST-300H, AST-300J)

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.

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

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, Huangpu District, Guangzhou, � Guangdong, China
� Tel: +86 20 8266 2446

Email: regulatory@glomed-info.com

3. Subject Device Information

Health Expert Electronic Stimulator � Trade Name:
Electronic Stimulator � Common Name:
Stimulator, Nerve, Transcutaneous, Muscle, Powered, For Classification name: �
Muscle Conditioning, Over-The-Counter
Neurology, Physical Medicine � Review Panel:
NUH, NGX � Product Code:
ll � Regulation Class:
882.5890, 890.5850 � Regulation Number:

4. Predicate Device Information

Sponsor	Shenzhen OSTO Technology Company Limited
Device Name and Model	Health Expert Electronic StimulatorModel: AST-300C and AST-300D
510(k) Number	K133929
Product Code	NUH, NGX
Regulation Number	882.5890, 890.5850

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Regulation Class	II
------------------	----

2. Device Description

The electronic stimulatory module has the operating elements of ON/OFF Switch, Display screen, 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.

5. 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)

6. 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 60601-1-11 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"
� 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

7. Comparison to predicate device and conclusion

The technological characteristics, features, specifications, mode of operation, and intended use of Electronic Muscle Stimulator is substantially equivalent to the predicate devices quoted above.

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The differences between the subject device and predicate devices do not raise new issues of safety or effectiveness.

Elements ofComparison	Subject Device	Predicate Device	Remark
Device Name andModel	Health Expert ElectronicStimulatorModel: AST-300F, AST-300H, AST-300J	Health Expert ElectronicStimulatorModel: AST-300C andAST-300D	--
510(k) Number	Applying	K133929	--
Intended Use	PMS (Mode 1~~8)It is intended to stimulatehealthy muscles in order to 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 applyingcurrent to stimulate nerve.	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 fromexercise or normalhousehold work activitiesby applying current tostimulate nerve.	SE
Power Source(s)	Adaptor Input: 100-240Vac, 50-60Hz, 0.1AOutput: 5Vdc, 1AUnit Input: 5Vdc, 1A	Adaptor Input: 100-240Vac, 50-60Hz, 0.1AOutput: 5Vdc, 1AUnit Input: 5Vdc, 1A	SE
-Method of LineCurrent Isolation	Type BF Applied Part	Type BF Applied Part	SE
PatientLeakageCurrent	NC	AC: 54.5μA, DC: 0.5μA	AC: 54.5μA,DC: 0.5μA	SE
	SFC	AC:120.0μΑ, DC: 0.6μΑ	AC:120.0μA, DC: 0.6μΑ	SE
Average DCcurrent throughelectrodes whendevice is on butno pulses arebeing applied		< 0.01μA	< 0.01μA	SE
Elements ofComparison	Subject Device	Predicate Device	Remark
Number of OutputChannels:	2	2	SE
Number of OutputModes	25	25	SE
Output IntensityLevel	99 steps	99 steps	SE
Synchronous orAlternating?	Synchronous	Synchronous	SE
Method ofChannel Isolation	Voltage TransformIsolation"Body-" and "Body-"buttons for body channel,"Sole+" and "Sole-" buttonsfor 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	SE
Software/Firmware/MicroprocessorControl?	Yes	Yes	SE
AutomaticOverload Trip	No	No	SE
Automatic No-Load Trip	No	No	SE
Automatic ShutOff	Yes.	Yes	SE
User OverrideControl	Yes	Yes	SE
IndicatorDisplay	On/OffStatus	Yes	Yes	SE
	LowBattery	No	No	SE
	Voltage/CurrentLevel	Yes	Yes	SE
Timer Range	25min	25min	SE
Elements ofComparison	Subject Device	Predicate Device	Remark
Weight	1.9Kg (Withoutaccessories)	2Kg (Without accessories)	SENote 1
Dimensions	429.1mm x 426.6mm x153.8mm	428mm x 428.8mm x185mm	SENote 1
Housing Materialsand Construction	Main unit: ABS plastic	Main unit: ABS plastic	SE
Waveform	Pulsed, symmetric,biphasic	Pulsed, symmetric,biphasic	SE
Shape	Rectangular, withinterphase interval	Rectangular, withinterphase interval	SE
Maximum OutputVoltage	44V±10% @ 500Ω80V±10% @ 2KΩ112V±10% @ 10KΩ	44V±10% @ 500Ω80V±10% @ 2KΩ112V±20% @ 10KΩ	SE
Maximum OutputCurrent	88mA±10% @ 500Ω40mA±10% @ 2KΩ11.2mA±10% @ 10KΩ	88mA±10% @ 500Ω40mA±10% @ 2KΩ11.2mA±10% @ 10KΩ	SE
Pulse Duration	120µs	120µs	SE
Pulse frequency	77.3Hz	77.3Hz	SE
Net Charge (perpulse)	0µC @ 500ΩMethod: Balancedwaveform	0µC @ 500ΩMethod: Balancedwaveform	SE
Maximum PhaseCharge	10.56µC @ 500Ω	12.78µC @ 500Ω	SE
MaximumAverage Current	1.63mA @ 500Ω	0.968mA @ 500Ω	SE
Maximum CurrentDensity(r.m.s )	0.0326mA/cm² @ 500Ω	0.235mA/cm² @500Ω	SE
MaximumAverage PowerDensity	0.000651mW/cm² @ 500Ω	1.38mW/cm² @ 500Ω	SE
ON Time	0.6s	0.6s	SE
OFF Time	0.6s	0.6s	SE
Elements ofComparison	Subject Device	Predicate Device	Remark

Environment foroperating	Temperature: 5 ~ 45° CHumidity: 20 ~ 65% RH	Temperature: 5 ~ 45°CHumidity: 20 ~ 65% 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	SE
Biocompatibility	All user directly contactingmaterials are compliancewith ISO10993-5 andISO10993-10requirements.	All user directly contactingmaterials are compliancewith ISO10993-5 andISO10993-10requirements.	SE
Electrical Safety	Comply with IEC 60601-1and IEC 60601-2-10	Comply with IEC 60601-1and IEC 60601-2-10	SE
EMC	Comply with IEC 60601-1-2	Comply with IEC 60601-1-2	SE

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Comparison in Detail(s):

Note 1: Although the " Weight" and "Dimensions"are a little different from the predicate device, but the differences will not raise any safety or effectiveness issue.

Finial Conclusion:

The subject devices "Health Expert Electronic Stimulator, model AST-300F, AST-300H, AST-300J" are Substantial Equivalent to the predicate device K133929.

8. Date of the summary prepared: December 4, 2019

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).