To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back of neck, back, arm, and leg, due to strain from exercise or normal household and work activities.

Neck Pad is used on back of neck.
Meridian Pad is used on shoulder, waist, back, arm and leg.

Device Description

This instrument is a new generation of a household multifunctional device based on physics, modern microelectronics and clinical practices, it uses low-frequency electronic therapy, and circular traction vibration to temporarily alleviate the pain associated with sore and aching muscles in the shoulder, waist, neck, back, arm, and leg. The main unit is used for the back of the neck and the streamlined ring design follows the physiological curvature of the human body. The Meridian Pad is used on the shoulder, waist, back, arm and leg.

The device has 2 operation modes: Stimulation and heating. The stimulation has 2 modes for stimulating, and 50 output Intensity Levels. The heating only has 1 mode for heating and 3 temperature levels. The device can give a certain electrical pulse through 2 pairs of electrode pads that are placed on the skin to help users to enjoy stimulation on the shoulder, waist, back, arm, and leg when using the individual Meridian pads or on the back of the neck when using the Neck Pad.

For Model AST-905A and AST-905H: The remote control of this device is user-friendly controlled because it has the operating elements of the ON/OFF button. left or right button, and increase or decrease button. The device is equipped with accessories of electrode pads and an electrode wire. The LCD display screen can show the selected mode, the stimulation, and the time remaining of an application mode. The device can be successfully opened only when both the switch button of the remote control and the main unit turned on. When the device connected to the remote control, the remote control is the only controller to select the pulse modes, temperature modes, pulse intensity, temperature levels and adjust the treatment time.

For Model AST-905D: The user can control the device effectively by the buttons on the main unit. There are 5 operation buttons: switch button, "M" button, ""C" button and "—" button. The switch button can help user to turn on/off the device, the "M" button intended to select the "C" button intended to select the temperature mode and the "-" button and "--" button intended to increase or decrease the Intensity Levels or temperature levels. The device is equipped with accessories of Meridian pads and an electrode wire.

AI/ML Overview

This document (K210756) is a 510(k) Premarket Notification for a Transcutaneous Electrical Nerve Stimulator (TENS) device. It demonstrates substantial equivalence to previously cleared devices. Based on the provided text, there is no acceptance criteria or study that proves the device meets specific performance criteria for AI/ML or diagnostic accuracy, as this is a physical medical device (TENS) and not an AI-powered diagnostic tool.

The acceptance criteria and studies described in your request (related to sample size, expert ground truth, MRMC studies, standalone performance, etc.) are typically applicable to diagnostic AI/ML-powered medical devices that provide results requiring human interpretation or that perform a diagnostic function. This document, however, describes a TENS device, which provides electrotherapy for pain relief.

Therefore, many of your requested points are not applicable to the information contained in this 510(k) summary. The "acceptance criteria" for this type of device are primarily compliance with relevant electrical safety, electromagnetic compatibility, usability, software validation, waveform, and biocompatibility standards, rather than diagnostic performance metrics.

Here's a breakdown of what is applicable from your request, and why the rest is not:

Applicable Information from the Document:

1. A table of acceptance criteria and the reported device performance:
- The document presents a comparison table (Section 7) showing the subject device's specifications and how they compare to predicate devices. This implicitly represents the "performance" relevant to this device type and its "acceptance criteria" are that these specifications are substantially equivalent and meet established safety standards.
- Acceptance Criteria Mentioned (Implicitly or Explicitly):
  - Compliance with IEC 60601-1-11 (General requirements for basic safety and essential performance - Home healthcare environment)
  - Compliance with IEC 60601-2-10 (Particular requirements for the basic safety and essential performance of nerve and muscle stimulators)
  - Compliance with IEC 60601-1-2 (Electromagnetic compatibility)
  - Compliance with IEC 62366 (Usability)
  - Compliance with FDA "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (for software verification and validation)
  - Compliance with "Guidance for Transcutaneous Electrical Nerve Stimulator for Pain Relief Intended for Over the Counter Use and Guidance for Powered Muscle Stimulator for Muscle Conditioning" (for waveform test)
  - Biocompatibility per ISO 10993-5 (Cytotoxicity) and ISO 10993-10 (Irritation and Sensitization)
  - Electrical characteristics (e.g., Maximum Output Voltage, Maximum Output Current, Pulse Duration, Pulse frequency, Net Charge, Maximum Phase Charge, Max Average Current, Max Current Density, Max Average Power Density) falling within acceptable ranges and being equivalent to predicates.
- Reported Device Performance (Examples from Table 7. Comparison to predicate device):
  - Electrical Safety: Complies with IEC 60601-1 and IEC 60601-2-10.
  - EMC: Complies with IEC 60601-1-2.
  - Biocompatibility: Complies with ISO 10993-5 and ISO 10993-10. (Stated as identical to cleared components in K172897)
  - Maximum Output Voltage: 44V±10% @ 500Ω; 80V±10% @ 2KΩ; 112V±10% @ 10KΩ
  - Maximum Output Current: 88mA±10% @ 500Ω; 40mA±10% @ 2KΩ; 11.2mA±10% @ 10KΩ
  - Pulse Duration: 120μs
  - Pulse frequency: 77.3Hz
  - Net Charge (per pulse): 0μC @ 500Ω (Balanced waveform)
  - Maximum Phase Charge @ 500Ω: 10.56μC
  - Maximum Average Current @ 500Ω: 1.63 mA
  - Maximum Current Density (r.m.s) @ 500Ω: 0.0326 mA/cm²
  - Maximum Average Power Density @ 500Ω: 0.0000266 mW/cm²
Sample sized used for the test set and the data provenance: Not applicable. This device's safety and performance are evaluated through bench testing against standards, not through clinical trials or data sets for diagnostic accuracy.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. There is no "ground truth" establishment in the diagnostic sense for a TENS device.
Adjudication method: Not applicable.
If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable. This is not a diagnostic imaging device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a physical TENS device, not an AI algorithm. Its performance is related to its electrical output and physical safety, not algorithmic accuracy.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. The "ground truth" for this device type relates to compliance with electrical, mechanical, and biological safety standards, verified through bench testing and adherence to established reference values from regulations and guidance documents.
The sample size for the training set: Not applicable. This device does not use a "training set" in the context of machine learning.
How the ground truth for the training set was established: Not applicable.

Summary of the Study Proving Device Meets Acceptance Criteria:

The document states that the NECK CARE THERAPY, Model: AST-905A, AST-905D, AST-905H device has been evaluated for safety and performance by lab bench testing. This type of evaluation demonstrates compliance with recognized medical device standards and relevant FDA guidance documents for TENS devices.

The specific tests performed include:

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.
Usability test: According to IEC 62366 standard.
Software verification and validation test: According to FDA guidance for software in medical devices.
Waveform test: Conducted to verify output specifications according to FDA guidance for TENS devices.
Biocompatibility testing: Confirmed that body-contacting components (Electrode Pads and Neck Pad) comply with ISO 10993-5 (Cytotoxicity) and ISO 10993-10 (Irritation and Sensitization). This was cross-referenced to components cleared under predicate device K172897.

The conclusion is that the device is Substantially Equivalent to the predicate devices (K172897 and K190783) because its technological characteristics, features, specifications, materials, mode of operation, and intended use are similar, and differences do not raise new safety or effectiveness issues. The "acceptance criteria" for this submission are met when the rigorous bench testing results demonstrate compliance with these established safety and performance standards for TENS devices.

Summary

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June 11, 2021

Shenzhen OSTO Technology Company Limited % Cassie Lee Submission Correspondent Guangzhou GLOMED Biological Technology Co., Ltd. 2231, Building 1, Rui Feng Center, Kaichuang Road, Huangpu District. Guangzhou, Guangdong, China 510663

Re: K210756

Trade/Device Name: Neck Care Therapy, Model: AST-905A, AST-905D, AST-905H Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator For Pain Relief Regulatory Class: Class II Product Code: NUH Dated: March 10, 2021 Received: March 15, 2021

Dear Ms. 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 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 Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K210756

Device Name NECK CARE THERAPY (Model: AST-905A, AST-905D, AST-905H)

Indications for Use (Describe)

To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, arm, and leg, due to strain from exercise or normal household and work activities.

Neck Pad is used on back of neck.
Meridian Pad is used on shoulder, waist, back, arm and leg.

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 of K210756

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 Manager) Email: annaosto@163.com

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

2. Subject Device Information

Common Name: Stimulator, Nerve, Transcutaneous, Over-The-Counter, Stimulator Trade Name: NECK CARE THERAPY, Model: AST-905A, AST-905D, AST-905H Classification Name: Transcutaneous electrical nerve stimulator for pain relief, Review Panel: Neurology Product Code: NUH Regulation Number: 882.5890 Regulation Class: II

3. Predicate Device Information Predicate Device 1:

510(K) Number: K172897 Company Name: Shenzhen OSTO Technology Co., Ltd. Address: No.43 Longfeng Road, Xinsheng Community, Longgang Street Longgang District, Shenzhen City Guangdong Province, CHINA Trade/Device Name: Neck Care Therapy, Models: SYK-509B Common Name: Electronic Stimulator Regulation Number: 882.5890 Regulatory Class: II Product Code: NUH

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,

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Shenzhen City, Guangdong Province, China Trade/Device Name: Health Expert Electronic Stimulator (model: AST-300L) Common Name: Transcutaneous electrical nerve stimulator for pain relief Regulation Number: 882.5890, 890.5850 Regulatory Class: II Product Code: NUH, NGX

4. Device Description

For Model AST-905A and AST-905H:

The remote control of this device is user-friendly controlled because it has the operating elements of the ON/OFF button. left or right button, and increase or decrease button.

The device is equipped with accessories of electrode pads and an electrode wire.

The LCD display screen can show the selected mode, the stimulation, and the time remaining of an application mode.

The device can be successfully opened only when both the switch button of the remote control and the main unit turned on.

When the device connected to the remote control, the remote control is the only controller to select the pulse modes, temperature modes, pulse intensity, temperature levels and adjust the treatment time.

For Model AST-905D:

The user can control the device effectively by the buttons on the main unit. There are 5 operation buttons: switch button, "M" button, ""C" button and "—" button. The switch button can help user to turn on/off the device, the "M" button intended to select the "C" button intended to select the temperature mode and the "-" button and "--" button intended to increase or decrease the Intensity Levels or temperature levels.

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The device is equipped with accessories of Meridian pads and an electrode wire.

5. Intended Use / Indications for Use

Meridian Pad is used on shoulder, waist, back, arm and leg.

6. Test Summary

NECK CARE THERAPY, Model: AST-905A, AST-905D, AST-905H 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
� Usability test according to IEC 62366 standard
◆ Software verification and validation test according to the requirements of the FDA "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices"
◆ The waveform test 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".
� Biocompatibility:

The body-contacting components of this device are Electrode Pads and Neck Pad. And the Electrode Pads and Neck Pad comply with biocompatibility standards ISO 10993-5 (Cytotoxicity) and ISO 10993-10 (Irritation and Sensitization) because the Electrode Pads and Neck Pad of the subject device are identical to those that had been cleared under K172897 (which clearance as K172897 on 12/07/2018) and been marketed to US market.

So. we have reason to believe that the Electrode Pads and Neck Pad are safe for the users. The Electrode Pads and Neck Pad comply with the following standards.

ISO 10993-5, Biological Evaluation of Medical Devices Part 5: Tests for In Vitro Cytotoxicity;
ISO 10993-10, Biological Evaluation of Medical Devices Part 10: Tests for Irritation and Skin Sensitization.

7. Comparison to predicate device and conclusion

The technological characteristics, features, specifications, materials, mode of operation, and intended use of NECK CARE THERAPY (Model: AST-905A, AST-905D, AST-905H) 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	NECK CARETHERAPYModel: AST-905A,AST-905D and AST-905H	Neck Care TherapyAST-905B or SYK-509B	Health ExpertElectronicStimulator (model:AST-300L)	--
510(k) Number	K210756	K172897	K190783	--
Intended Use &Indications for Use	To be used fortemporary relief of painassociated with soreand aching muscles inthe shoulder, waist,back of neck, back,arm, and leg, due tostrain from exercise ornormal household andwork activities.- Neck Pad is used onback of neck.- Meridian Pad is usedon shoulder, waist,back, arm and leg.	To be used fortemporary relief ofpain associated withsore and achingmuscles in theshoulder, waist, backof neck, back, arm,and leg, due to strainfrom exercise ornormal householdand work activities.— Neck Pad is usedin back of neck.— Meridian Pad isused in shoulder,waist, back, and arm.	PMS (Mode 1~~8)It is intended tostimulate healthymuscles in order toimprove andfacilitate muscleperformance.TENS (Mode 9~~25)To be used fortemporary relief ofpain associated withsore and achingmuscles in theshoulder, waist,back, back of theneck, arm, leg, andfoot due to strainfrom exercise ornormal householdwork activities byapplying current tostimulate nerve.	SE
Power Source(s)	Main Unit: 3.7Vdc,2200mAh lithiumbatteryPower Adaptor:Input: 100~240Vac,50/60Hz, 0.2A;Output: 5Vdc, 1ARemote Control:Battery: 3Vdc, 1.5VAAA x 2	Main Unit:Power Adaptor:Input:100~240Vac,50/60Hz, 0.2A;Output: 5Vdc, 1ABattery: 3.7Vdc,2200mAhRemote Control:Battery: 3Vdc, AAA x2Unit Input: 5Vdc, 1A	Adaptor Input:100-240Vac, 50-60Hz, 0.1AOutput: 5Vdc, 2AUnit Input: 5Vdc, 2A	SE
Method of LineCurrent Isolation	Type BF Applied Part	Type BF Applied Part	Type BF AppliedPart	SE
PatientLeakageCurrent	NCSFC	AC: 54.5μA,DC: 0.5μAAC:120.0μA,DC: 0.6μA	AC: 54.5μA,DC: 0.5μAAC:120.0μA,DC: 0.6μA	AC: 54.5μA, DC:0.5μAAC: 120.0μA, DC:0.6μA	SE
Average currentthrough electrodeswhen device is on butno pulses are beingapplied		< 0.01μA	< 0.01μA	< 0.01μA	SE
Number of Modes		3	2	25	SENote 1
Number ofOutput Channel		1	1	2	SE
Output Intensity Level		For stimulating: 50For heating: 3	50 steps	99 steps	SENote 1
Heating temperature		30-40°C	N/A	30-40°C	SE
Synchronous orAlternating?		Synchronous	Synchronous	Synchronous	SE
Method of ChannelIsolation		Voltage TransformIsolation	Voltage TransformIsolation	Voltage TransformIsolation"Body+" and "Body-"buttons for bodychannel," Sole+" and "Sole-"buttons for feetchannel	SE
Regulated Current orRegulated Voltage?		Voltage Control	Voltage Control	Voltage Control	SE
Software/Firmware/Microprocessor Control?		Yes	Yes	Yes	SE
Automatic OverloadTrip		No	No	No	SE
Automatic No-LoadTrip		No	No	No	SE
Automatic Shut Off		Yes	Yes	Yes	SE
User Override Control		Yes	Yes	Yes	SE
IndicatorDisplay	On/OffStatus	Yes	Yes	Yes	SE
	LowBattery	Yes	Yes	No	SE
	Voltage/CurrentLevel	Yes	Yes	Yes	SE
Timer Range		5-30 min	5-30 min	25 to 60 min	SE
Weight
	For Main Unit:AST-905A: 193g;AST-905D: 229g;AST-905H: 178gFor Electrode:Patch Electrode: 44g	Main Unit:SYK-509B: 222gElectrode:Patch Electrode: 44g	2.1Kg (Withoutaccessories)	SENote 2
Dimensions
	For Main Unit:AST-905D:$166.0159.555.6$ mmAST-905H:$173.4156.343.4$ mmFor Electrode:Meridian Pad: $8.9*5.8$ cmEffective area: $50.04$ cm2Neck Pad: $42.3$ mm x $29.5$ mm	Main Unit:SYK-509B:$187.216967.3$ mmPatch Electrode:$8.9*5.8$ cm	$429.2$ mm x $401$ mmx $152.8$ mm	SENote 2
Housing Materials andConstruction	For Electrode Pads:White silica gel, Blackconductive silicone,Transparentconductive adhesivesilicone, TransparentPET silicone	Electrode Pads:White silica gel,Black conductivesilicone, Transparentconductive adhesivesilicone, TransparentPET silicone	Main unit: ABSplastic	SE
	For Neck Pad:Stainless steel	Sticky metal sheet:Nickel plating	No publicly available
	For Unit Housing: ABSplastic	Unit Housing: ABSplastic	No publicly available
Waveform	Pulsed, symmetric,biphasic	Pulsed, symmetric,biphasic	Pulsed, symmetric,biphasic	SE
Shape	Rectangular, withinterphase interval	Rectangular, withinterphase interval	Rectangular, withinterphase interval	SE
Maximum OutputVoltage	44V±10% @ 500Ω	44V±10% @ 500Ω	44V±10% @ 500Ω	SE
	80V±10% @ 2KΩ	80V±10% @ 2KΩ	80V±10% @ 2KΩ	SE
	112V±10% @ 10KΩ	112V±10% @ 10KΩ	112V±10% @ 10KΩ	SE

Maximum OutputCurrent	88mA±10% @ 500Ω	88mA±10% @ 500Ω	88mA±10% @500Ω	SE
	40mA±10% @ 2KΩ	40mA±10% @ 2KΩ	40mA±10% @ 2KΩ	SE
	11.2mA±10% @ 10KΩ	11.2mA±10% @10KΩ	11.2mA±10% @10KΩ	SE
Pulse Duration	120μs	120μs	120μs	SE
Pulse frequency	77.3Hz	77.3Hz	77.3Hz	SE
Net Charge (perpulse)	0μC @ 500ΩMethod: Balancedwaveform	0μC @ 500ΩMethod: Balancedwaveform	0μC @ 500ΩMethod: Balancedwaveform	SE
Maximum PhaseCharge @ 500Ω	10.56μC	12.78μC	10.56μC	SE
Maximum AverageCurrent@ 500Ω	1.63 mA	0.968 mA	1.63 mA	SE
Maximum CurrentDensity (r.m.s) @500Ω	0.0326 mA/cm²	0.235 mA/cm²	0.0326 mA/cm²	SE
Maximum AveragePower Density @500Ω	0.0000266 mW/cm²	1.38 mW/cm²	0.0000266 mW/cm²	SE
OperatingEnvironment	Temperature: 10~40 ℃Humidity: 30% -75%RHAtmospheric Pressure:860 hPa to 1060 hPa	Temperature:10~40℃Humidity: 30% -75%RHAtmosphericPressure: 860 hPa to1060 hPa	Temperature:5~45°CHumidity: 20% -65%RHAtmospheric	SE
Storage Environment	Temperature: -25 -+70°CHumidity: ≤90% RH,Atmospheric Pressure:860 hPa to 1060 hPa	Temperature: -25 -+70°CHumidity: ≤90% RH,AtmosphericPressure: 860 hPa to1060 hPa	Temperature:0~45℃Humidity: 10% -90%RH	SE
Biocompatibility	Biocompatibility testaccording to ISO10993-5 and ISO10993-10	Biocompatibility testaccording to ISO10993-5 and ISO10993-10	All user directlycontacting materialsare compliance withISO 10993-5 andISO 10993-10	SE
			requirements.

Electrical Safety	Comply with IEC60601-1 and IEC60601-2-10	Comply with IEC60601-1 and IEC60601-2-10	Comply with IEC60601-1 and IEC60601-2-10	SE
EMC	Comply with IEC60601-1-2	Comply with IEC60601-1-2	Comply with IEC60601-1-2	SE

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Note 1:

Although the "Number of Modes", and "Output Intensity Level" of subject device a little different from the predicate devices, they all meet the IEC 60601-1-11 and IEC 60601-2-10 requirements. Therefore, the differences will not raise any safety or effectiveness issue.

Note 2:

Although the "Weight" and "Dimensions" of subject device a little different from the predicate devices, they all meet the requirements by safety standards IEC 60601-1-11, IEC 60601-2-10 and IEC 60601-1-2 required. Therefore, the differences will not raise any safety or effectiveness issue.

Final Conclusion:

The subject device "NECK CARE THERAPY, Model: AST-905D, AST-905D, AST-905H " is Substantial Equivalent to the predicate devices K172897 and K190783.

8. Date of the summary prepared: June 11, 2021

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).