TENS: 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. It is also intended for symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis. PMS: It is intended to stimulate healthy muscles in order to improve and facilitate muscle performance. Heating: It is intended for temporary relief of minor aches and pains.

Device Description

The Low-frequency stimulator is a portable device. It has 10 modes: 9 stimulation modes each has 99 levels of intensity and 1 heating mode has 3 levels of heating intensity, which can give certain stimulation to help the users relax their muscle and relief their pain. The Low-frequency stimulator has 7 buttons on the main unit: Press Power button to turn on/off the device. Press "Mode+" and "Mode-" buttons to select 9 stimulation modes; Press "Intensity+" and "Intensity-" to increase or decrease the stimulus intensity, there are a total of 99 intensities to choose from; Press "Heat" to adjust the heating temperature, there are three temperatures(38℃, 40℃ and 43℃) that can be adjusted. Press "Time" to adjust the treatment time, increasing by five minutes each time, up to 60 minutes. It will automatically shut down in 30 minutes by default when it is turned on. The LCD screen can show stimulation intensity, heating intensity, heating intensity and time remaining of an application mode. All the functions of the device can only be controlled by the button on the main unit. The device is equipped with an adapter, bandage, a pair of electrode wire. The electrode wire is used to connect the electrode pads to the main unit. There are four conductive heads on the main unit, which are mainly composed of stainless steel sheets and giving users stimulation and heating functions, and help users relieve knee pain. The stimulation and heating functions can happen simultaneously or independently by control the button on the main unit. When in use, the main unit is fixed with a bandage, and the electrode sheet is placed at the relevant treatment site according to the instructions. The electrode pads can be used on the guidance site for stimulation only when connected to the host. There are two models of the device, which differ only in appearance. The electrode pads are complying with the biocompatibility standards ISO 10993-5 (Cytotoxicity) and ISO 10993-10 (Irritation and Sensitization), are interchangeable.

AI/ML Overview

This document (K212989) is a 510(k) Premarket Notification for a Low-frequency Stimulator. The document details the product description, its intended use, and a comparison to predicate devices to demonstrate substantial equivalence, rather than providing details of a clinical study assessing the device's performance against specific acceptance criteria.

Therefore, most of the information requested in your prompt related to clinical study design, performance metrics, ground truth establishment, and expert involvement is not available within the provided text. The document explicitly states: "No clinical study is included in this submission."

However, I can extract the following information based on the provided text:

1. A table of acceptance criteria and the reported device performance:

Since no clinical study demonstrating performance against specific numerical acceptance criteria for clinical effectiveness (e.g., pain reduction percentage, muscle performance improvement metrics) was conducted or reported, such a table cannot be provided from this text. The acceptance criteria described are largely related to non-clinical testing and safety standards.

Acceptance Criteria (from non-clinical testing)	Reported Device Performance (as demonstrated by testing)
Electrical safety (IEC 60601-1, IEC 60601-1-11, IEC 60601-2-10)	Met the requirements
Electromagnetic compatibility (IEC 60601-1-2)	Met the requirements
Biocompatibility (ISO 10993-5, ISO 10993-10)	Met the requirements; electrode pads are compliant
Usability (IEC 62366-1)	Met the requirements
Software verification and validation (FDA Guidance for Pre-Market Submissions and for Software Contained in Medical Devices)	Met the requirements
Waveform test (Guidance for Transcutaneous Electrical Nerve Stimulator for Pain Relief Intended for Over the Counter Use and Guidance for Powered Muscle Stimulator for Muscle Conditioning)	Conducted to verify output specifications
Patient Leakage Current	AC: 54.5 μA, DC: 0.5 μA (met standards IEC 60601-1-2 and IEC 60601-2-10)
Maximum Skin Temperature	43°C (as claimed and compared to predicate)
Net Charge (per pulse)	0μC @ 500Ω (Balanced waveform)
Maximum Phase Charge	10.56μC @ 500Ω
Maximum Current Density	1.63mA @ 500Ω
Maximum Power Density	0.0000266mW/cm² @ 500Ω

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

Sample Size: Not applicable as no clinical test set was used. The evaluation was based on non-clinical (bench) testing.
Data Provenance: Not applicable for clinical data. For non-clinical testing, the tests were conducted by the manufacturer, Shenzhen OSTO Technology Company Limited, in China.

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

Not applicable as no clinical test set requiring expert-established ground truth was reported.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable as no clinical test set was reported.

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 a stimulator, not an AI-assisted diagnostic tool for image interpretation. No human reader study of this type was performed or is relevant.

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

Not applicable as this is a physical medical device, not a software algorithm for diagnostic interpretation. Its "performance" is measured by its physical output and adherence to safety standards. The software aspect mentioned is for verification and validation of the device's internal software control, not for standalone diagnostic performance.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

For the non-clinical testing, the "ground truth" or reference points were established by international and FDA-recognized standards (e.g., IEC 60601-1, ISO 10993-5, FDA Guidance documents for TENS and PMS devices). Device specifications and safety limits are derived from these standards.

8. The sample size for the training set:

Not applicable as no machine learning model requiring a training set was used for the device's clearance.

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

Not applicable as no machine learning model was used.

In summary, this 510(k) submission relies on non-clinical bench testing and comparison to legally marketed predicate devices to demonstrate safety and effectiveness for substantial equivalence, rather than de novo clinical study data.

Summary

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November 22, 2021

Shenzhen OSTO Technology Co., Ltd. % Cassie Lee Manager Guangzhou GLOMED Biological Technology Co., Ltd. 2231, Building 1, Rui Feng Center, Kaichuang Road, Huangpu District Guangzhou, Guangdong 510700 China

Re: K212989

Trade/Device Name: Low-frequency Stimulator (Model: AST-645, AST-646) Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous electrical nerve stimulator for pain relief Regulatory Class: Class II Product Code: NUH, NGX, NYN, GZJ, IPF, IRT Dated: September 15, 2021 Received: September 20, 2021

Dear Cassie Lee:

We have reviewed vour 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 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.

Amber Ballard, PhD Assistant 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

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Indications for Use

510(k) Number (if known) K212989

Device Name

Low-frequency Stimulator (Model: AST-645, AST-646)

Indications for Use (Describe) TENS:

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.

It is also intended for symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis.

PMS:

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

Heating:

It is intended 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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510(k) Summary for K212989

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

� Trade Name: Low-frequency stimulator (Model AST-645, AST-646)
� Common Name: Over-the-counter Transcutaneous Electrical Nerve Stimulator
� Classification name: Transcutaneous Electrical Nerve Stimulator For Pain Relief
� Review Panel: Physical Medicine
NUH, NGX, NYN, GZJ, IPF, IRT Product Code: �
ll � Requlation Class:
882.5890 Regulation Number: �
1. Predicate Device Information

Primary Predicate Devic Information

Jkh Usa, LLC � Sponsor
JKH Stimulator Plus � Device Name and Model
� 510(k) Number K191151

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NUH, NGX, NYN, GZJ, IPF, IRT � Product Code
� Regulation Number 882.5890
Requlation Class � 11

Secondary Predicate Device Information

Shenzhen OSTO Technology Company Limited Sponsor
Health Expert Electronic Stimulator (Model: AST-300L) � Device Name and Model
K190783 � 510(k) Number
NUH, NGX � Product Code
882.5890, 890.5850 � Regulation Number
� Requlation Class ll

2. Device Description

�

The Low-frequency stimulator has 7 buttons on the main unit:

Press Power button to turn on/off the device.

Press "Mode+" and "Mode-" buttons to select 9 stimulation modes;

Press "Intensity+" and "Intensity-" to increase or decrease the stimulus intensity, there are a total of 99 intensities to choose from;

Press "Heat" to adjust the heating temperature, there are three temperatures(38℃, 40℃ and 43℃) that

can be adjusted.
Press "Time" to adjust the treatment time, increasing by five minutes each time, up to 60 minutes. It will automatically shut down in 30 minutes by default when it is turned on.

The LCD screen can show stimulation intensity, heating intensity, heating intensity and time remaining of an application mode.

All the functions of the device can only be controlled by the button on the main unit. The device is equipped with an adapter, bandage, a pair of electrode wire. The electrode wire is used to connect the electrode pads to the main unit. There are four conductive heads on the main unit, which are mainly composed of stainless steel sheets and giving users stimulation and heating functions, and help users relieve knee pain. The stimulation and heating functions can happen simultaneously or independently by control the button on the main unit. When in use, the main unit is fixed with a bandage, and the electrode sheet is placed at the relevant treatment site according to the instructions. The electrode pads can be used on the guidance site for stimulation only when connected to the host. There are two models of the device, which differ only in appearance.

The electrode pads are complying with the biocompatibility standards ISO 10993-5 (Cytotoxicity) and ISO 10993-10 (Irritation and Sensitization), are interchangeable.

5. Intended Use / Indications for Use

TENS:

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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.

It is also intended for symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis.

PMS:

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

Heating:

lt is intended for temporary relief of minor aches and pains.

6. Test Summary

6.1 Non-clinical testing was conducted to verify that the subject device met all design specifications, demonstrated safety based on current industry standards, and to demonstrate substantial equivalence to the predicate. The following tests were performed:

Low-frequency 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"
◆ 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

6.2 Summary of Clinical Performance Test

No clinical study is included in this submission.

7. Comparison to predicate device and conclusion

The technological characteristics, features, specifications, materials, Mode of operation, and intended use of Low-frequency 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	Primary Predicate Device	Secondary PredicateDevice	Remark
Device Name	Low-frequency stimulator(Model: AST-645, AST-646)	JKH Stimulator Plus	Health Expert ElectronicStimulatorModel: AST-300L	--
510(k) Number	K212989	K191151	K190783	--
Elements ofComparison	Subject Device	Primary Predicate Device	Secondary PredicateDevice	Remark
Intended Use	TENS: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.It is also intended forsymptomatic relief andmanagement of chronic,intractable pain and reliefof pain associated witharthritis.PMS:It is intended to stimulatehealthy muscles in orderto improve and facilitatemuscle performance.Heating:It is intended fortemporary relief of minoraches and pains.	TENS:PL-029K5BL, PL-029K15,and PL-029T are used fortemporary relief of painassociated with sore andaching muscles in theshoulder, waist, back, arm,and leg, due to strain fromexercise or normalhousehold and workactivities.PL-029K5BL, PL-029K15,and PL-029T are alsointended for symptomaticrelief and management ofchronic, intractable painand relief of painassociated with arthritis.The device of PL-029K5BLand PL-029K15 may beused during sleep. Thedevice of PL- 029K5BL andPL-029K15 is labeled foruse only with its owncompatible electrodes.PMS:PL-029K5BL, PL-029K15,and PL-029T are used tostimulate healthy musclesin order to improve andfacilitate muscleperformance. To be usedfor the improvement ofmuscle tone and firmness,and for strengtheningmuscles in the arms,abdomen, legs, andbuttocks. Not intended foruse in any therapy or forthe treatment of anymedical conditions ordiseases.PL-029K5BL, PL-029K15,and PL-029T are alsointended to temporarilyincrease local bloodcirculation in the healthymuscles of lowerextremities.Heating:	PMS (Mode 1~~8)It is intended to stimulatehealthy muscles in orderto improve and facilitatemuscle performance.TENS (Mode 9~~25)To be used fortemporary relief of painassociated with sore andaching muscles in theshoulder, waist, back,back of the neck, arm,leg, and foot due tostrain from exercise ornormal household workactivities by applyingcurrent to stimulatenerve.	SE
Elements ofComparison	Subject Device	Primary Predicate Device	Secondary PredicateDevice	Remark
			The device of PL-029T isintended for temporaryrelief of minor aches andpains.
Power Source(s)		Powered by adapter,100-240VAC, 50-60HzOutput: 9Vdc, 2AUnit Input: 9Vdc, 2A	Rechargeable or non-rechargeable battery	Adaptor Input:100-240Vac, 50-60Hz,0.1AOutput: 5Vdc, 2AUnit Input: 5Vdc, 2A	SENote 1
-Method of LineCurrent Isolation		Type BF Applied Part	Battery Supply	Type BF Applied Part	SE
-PatientLeakageCurrent	NC	DC: <1μA	N/A	AC: 54.5, DC: 0.5μA	SENote 1
	SFC	DC: <1μA	N/A	AC: 54.5, DC: 0.5μA
Number of OutputChannels:		2	1-2	2	SE
Number of OutputModes		For stimulation: 9 modesFor heating: 1 mode	PL-029K5BL: 6-8 PL-029K15: 1-4 PL-029T: 8	25	SENote 2
OutputIntensityLevel		For stimulation: 99 levelsFor heating: 3 levels(38°C, 40°C and 43°C)	N/A	99 steps	SENote 2
Synchronous orAlternating		Synchronous	N/A	Synchronous	SE
Method of ChannelIsolation		2	N/A	2	SE
Regulated Currentor RegulatedVoltage?		Voltage	Voltage	Voltage Control	SE
Software/Firmware/MicroprocessorControl?		Yes	Yes	Yes	SE
AutomaticOverload Trip		No	No	No	SE
Automatic No-LoadTrip		No	Yes	No	SE
Automatic Shut Off		Yes	Yes	Yes	SE
Elements ofComparison		Subject Device	Primary Predicate Device	Secondary PredicateDevice	Remark
IndicatorDisplay	Override	Yes	Yes	Yes	SE
	On/OffStatus	Yes	Yes	Yes	SE
	Lowbattery	No	Yes	No	SE
Voltage /currentlevel		Yes	Yes	Yes	SE
Timer Range		5-60 min	PL-029K5BL: 10-540minutesPL-029K15: 10-60 minutesPL-029T: 10-60 minutes	25 to 60 min	SENote 2
Dimensions(mm) [Lx W x D]		Model AST-622 andModel AST-645:306.2mm179.3mm159.4mmModel AST-646:306.0mm179.3mm161.0mm	PL-029K5BL: 66x56x18PL-029K15:70x62x16PL-029T: 95x55x15	429.2mm x 401mm x152.8mm	SENote 2
Housing Materialsand Construction		Main unit: ABS Plastic	Silicone & ABS	Main unit: ABS plastic	SE
Maximum skintemperature		43°C	43°C	Not Publicly Available	SE
Waveform		Symmetrical Biphasic	Biphasic	Pulsed, SymmetricBiphasic	SE
Shape		Rectangular	Rectangular	Rectangular, withinterphase interval	SE
		44V±10% @ 500Ω	PL-029K5BL: 65PL-029K15: 36PL-029T: 46	44V±10% @ 500Ω
MaximumVoltage	Output	80V±10% @ 2KΩ	PL-029K5BL: 132PL-029K15: 72PL-029T: 92	80V±10% @ 2KΩ	SE
		112V±10% @ 2KΩ	PL-029K5BL: 180PL-029K15: 125PL-029T: 136	112V±10% @ 2KΩ	SE
MaximumCurrent	Output	88mA±10% @ 500Ω	PL-029K5BL: 130PL-029K15: 72	88mA±10% @ 500Ω	SE
Elements ofComparison	Subject Device	Primary Predicate Device	Secondary PredicateDevice	Remark
	PL-029T: 92
	40mA±10% @ 2KΩ	PL-029K5BL: 66PL-029K15: 36PL-029T: 47	40mA±10% @ 2KΩ
	11.2mA±10% @ 10KΩ	PL-029K5BL: 18PL-029K15: 12.5PL-029T: 13.6	11.2mA±10% @ 10KΩ
Pulse Duration	120μs	PL-029K5BL: 50~500PL-029K15: 100PL-029T: 104	120μs	SE
Pulse frequency(Hz)	77.3Hz	PL-029K5BL: 1~~500PL-029K15: 1~~100PL-029T: 1.2~167	77.3Hz	SE
Net Charge (perpulse)	0μC @ 500ΩMethod: Balancedwaveform	N/A	0μC @ 500ΩMethod: Balancedwaveform	SE
Maximum PhaseCharge(μC) at500Ω	10.56μC @ 500Ω	PL-029K5BL: 78PL-029K15: 14.5PL-029T: 19.3	10.56μC @ 500Ω	SE
Maximum CurrentDensity	1.63mA @ 500Ω	N/A	1.63mA @ 500Ω	SE
Maximum PowerDensity	0.0000266mW/cm² @500Ω	PL-029K5BL: 28PL-029K15: 1.68PL-029T: 2.22	0.0000266mW/cm² @500Ω	SE
ON Time	2s	1~20 s	240 us	SE
OFF Time	2s	0~10 s	12700 us	SE
Biocompatibility	ISO 10993-5,ISO 10993-10	ISO 10993-5,ISO 10993-10	All user directlycontacting materials arecompliance withISO10993-5 andISO10993-10requirements.	SE
Electrical Safety	IEC 60601-1,IEC 60601-1-11,IEC 60601-2-10	ANSI AAMI ES60601-1,IEC 60601-1-11,IEC 60601-2-10	Comply with IEC 60601-1 and IEC 60601-2-10	SE
EMC	IEC 60601-1-2	IEC 60601-1-2	Comply with IEC 60601-1-2	SE

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Comparison in Detail(s): Note 1:

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Although the "Power Source(s)" and "Patient Leakage Current" of subject device are a little different from the predicate device, but they all meet the requirements by IEC 60601-1-2 and IEC 60601-2-10 standards required. So the differences will not raise any safety or effectiveness issue.

Note 2:

Although the "Dimensions(mm) [L x W x D]", "Timer Range", "ON Time" and "OFF Time" of subject device are a little different from the predicate device, but the differences will not raise any safety or effectiveness issue.

8. Finial Conclusion:

The subject devices "Low-frequency stimulator, model AST-645, AST-646" are Substantial Equivalent to the predicate device K191151 and K190783.

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).