Air Compression Leg Massager is indicated for the temporary relief of minor muscle aches and for temporary increase in circulation to the treated areas in good health. Air Compression Leg Massager simulates kneading and stroking of tissues by using an inflatable garment.

Device Description

Air Compression Leg Massager (Model: EMK-701) is a portable and rechargeable device. lt is intended to be an over-the-counter portable inflatable tube massage system which simulates kneading and stroking of tissue with the hands by use of inflatable pressure cuffs. It can be used to temporarily increase blood circulation and temporarily relieve minor muscle aches and pains.

Air Compression Leg Massager supplied clean and non-sterile, utilizes the pneumatically controlled leg wraps actuated by an electronically controlled air pump unit. A pump, battery and control components are protectively housed in a plastic case of Handheld Controller. Function buttons and light emitting diode (LED) indicators on the Handheld Controller make up the user interface. There are 3 ports at the bottom of Handheld Controller for connecting the alternating current (AC) adapter plug and two air hoses.

Each leg wrap has an air hose for connection to Handheld Controller, and both encase a 2chamber air bladder inside. Feet and calves can be wrapped and massaged separately by the two chambers. The soft medical fabric of wraps provides patient comfort and biocompatibility compliance.

In operation, the user turns the power on via the Power button. Then the Handheld Controller controls the inflating and deflating of the air bladders according to preset program parameters. The air pressure is monitored by an internal pressure sensor and microprocessor. Once the pressure of the air bladder reaches the proper level, the pump is turned off for a rest period. The cycle of inflation and deflation repeats until the unit is turned off.

AI/ML Overview

The provided text is a 510(k) summary for the "Air Compression Leg Massager (model: EMK-701)," which is a medical device for temporary relief of muscle aches and improved circulation. This document primarily focuses on establishing substantial equivalence to previously cleared predicate devices through a comparison of technical specifications and performance testing. It does not describe a study that involves statistical acceptance criteria, human readers, or a clinical effectiveness study.

Based on the information provided, here's a breakdown of what is and isn't available:

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

The document includes a "Test Summary" section that lists several international standards to which the device was evaluated for its safety and performance. However, it does not provide specific acceptance criteria values (e.g., "Pass/Fail" thresholds) or quantitative reported device performance results against those criteria. It merely states that the device "has been evaluated for its safety and performance by lab bench testing as following:" and then lists the standards.

Acceptance Criterion (Standard)	Reported Device Performance
ANSI/AAMI ES60601-1:2012 (Basic Safety & Essential Performance)	"Evaluated" (No specific performance data or pass/fail reported)
IEC 62133-2:2017 (Secondary cells and batteries safety)	"Evaluated" (No specific performance data or pass/fail reported)
IEC 60601-1-2:2014 (EMC)	"Evaluated" (No specific performance data or pass/fail reported)
IEC 60601-1-11:2015 (Home healthcare environment)	"Evaluated" (No specific performance data or pass/fail reported)
ISO 10993-5:2009 (In Vitro cytotoxicity)	"Evaluated" (No specific performance data or pass/fail reported)
ISO 10993-10:2010 (Irritation and skin sensitization)	"Evaluated" (No specific performance data or pass/fail reported)

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

The document explicitly states: "No Clinical Test conducted." Therefore, there is no test set in the sense of patient data for a clinical study. The evaluations conducted were "lab bench testing" which typically refers to laboratory experiments on the device hardware and software, not human subjects.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):

Not applicable, as no clinical test was conducted and no "ground truth" based on expert consensus was established for a test set.

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

Not applicable, as no clinical test was conducted and no "ground truth" based on expert consensus was established for a test set.

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 an "Air Compression Leg Massager," not an AI-powered diagnostic or interpretive device that would involve human readers or AI assistance in the way an MRMC study would measure.

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

Not applicable, as this is a physical therapy device and not an AI algorithm.

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

Not applicable, as no clinical test involving patient data was conducted. The ground truth for the lab bench tests would be the specifications and requirements defined by the listed international standards themselves (e.g., "EMC emissions must be below X level," "biocompatibility tests must show no cytotoxicity").

8. The sample size for the training set:

Not applicable, as this is not an AI/machine learning device that requires a training set of data.

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

Not applicable, as this is not an AI/machine learning device that requires a training set of data.

In summary:

The provided document is a regulatory submission for a medical device that relies on establishing substantial equivalence to predicate devices through technical comparisons and compliance with recognized safety and performance standards via lab bench testing. It does not involve clinical studies, AI algorithms, human readers, or the typical "acceptance criteria" and "study" framework associated with evaluating software-as-a-medical-device or AI-driven diagnostics. The "study" mentioned for demonstrating compliance refers to the series of lab tests against international standards, rather than a clinical trial with patient data and expert ground truth.

Summary

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March 15, 2023

Xiamen Emoka Health Science & Technology Co., Ltd. Iris Fung Regulation Manager 6F, No.1 TianTai road, Science City, LuoGang District Guangzhou, Guangdong 361000 China

Re: K222991

Trade/Device Name: Air Compression Leg Massager (model: EMK-701) Regulation Number: 21 CFR 890.5650 Regulation Name: Powered inflatable tube massager Regulatory Class: Class II Product Code: IRP Dated: September 28, 2022 Received: September 28, 2022

Dear Iris Fung:

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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's

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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 (OS) 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,

Tushar Bansal -S

for Heather Dean, PhD Assistant Director THT5B3: Acute Injury Devices Team 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) K22991

Device Name

Air Compression Leg Massager (model: EMK-701)

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
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Prescription Use (Part 21 CFR 801 Subpart D)

X Over-The-Counter Use (21 CFR 801 Subpart C)

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Date of the summary prepared: Mar 10, 2023

510(k) Summary

510K: K222991

This summary of 510(K) safety and effectiveness information is being submitted in accordance with the requirement of 21 CFR 807.92. This is a Traditional 510(K) submission, and there were no prior submissions for the subject device.

1. Submitter'sInformation

Sponsor

� Company Name: Xiamen Emoka Health Science & Technology Co., Ltd.
Address: D Building, No.100, Jinfu Road, Chengnan Industrial Zone, Tong'an District, � Xiamen, China
� Phone: +86-592-7363861
� Email: emk@emoka.cn
Contact Person (including title): Zhang Feng (Quality Manager) �

Application Correspondent:

Xiamen Emoka Health Science & Technology Co., Ltd.. �
� Address: D Building, No.100, Jinfu Road, Chengnan Industrial Zone, Tong'an District, Xiamen, China
� Contact Person: Ms. Iris Fung
Title: Regulation Manager �
� Tel: +86-18588874857
� Email: mdc-fs@foxmail.com; jianda-lee@foxmail.com

Subject Device Information 2.

Type of 510(k) submission: Traditional �
Classification: Powered Inflatable Tube Massager �
� Trade Name: Air Compression Leg Massager
� Model: EMK-701
� Review Panel: Physical Medicine
Product Code: IRP �
Requlation Number: 21 CFR 890.5650 �
Regulation Class: 2 �

3. Predicate Device Information

Predicate Device I

510(k) number: K193354 �

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� Sponsor: Shenzhen Donqiilian Electronics Co., Ltd.
Classification: Powered Inflatable Tube Massager �
Trade Name: Air Compression Therapy Device � Model: S9019
� Review Panel: Physical Medicine
Product Code: IRP �
� Regulation Number: 21 CFR 890.5650
Regulation Class: 2 �

Predicate Device II

510(k) number: K212935 �
Sponsor: Xiamen Simo Electronic Co., Ltd �
� Classification: Powered Inflatable Tube Massager
Trade Name: Air Pressure Foot Massager �
� Model: SM-512F
Review Panel: Physical Medicine �
� Product Code: IRP
Regulation Number: 21 CFR 890.5650 �
Regulation Class: 2 �

4. Device Description

In operation, the user turns the power on via the Power button. Then the Handheld Controller controls the inflating and deflating of the air bladders according to preset program

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parameters. The air pressure is monitored by an internal pressure sensor and microprocessor. Once the pressure of the air bladder reaches the proper level, the pump is turned off for a rest period. The cycle of inflation and deflation repeats until the unit is turned off.

5. Intended Use / Indicationsfor Use

Air Compression Leg Massager is indicated for the temporary relief of minor muscle aches and pains and for temporary increase in circulation to the treated areas in people who are in good health. Air Compression Leg Massager simulates kneading and stroking of tissues by using an inflatable garment.

6. Test Summary

Air Compression Leg Massager has been evaluated for its safety and performance by lab bench testing as following:

� ANSI/AAMI ES60601-1:2012, Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance
� IEC 62133-2:2017, Secondary cells and batteries containing alkaline or other nonacid electrolytes - Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications - Part 2: Lithium systems
� IEC 60601-1-2:2014, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility
◆ IEC 60601-1-11:2015 Medical electrical equipment - part 1-11: general requirements for basic safety and essential performance - collateral standard: requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
� ISO 10993-5:2009, Biological evaluation of medical devices -- Part 5: Tests for In Vitro cytotoxicity
� ISO 10993-10:2010, 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, and intended use of Air Compression Leg Massager 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 I	Predicate Device II	Comparison
Manufacturer	Xiamen Emoka HealthScience & Technology Co.,Ltd.	Shenzhen DongjilianElectronics Co., Ltd.	Xiamen Simo Electronic Co.,Ltd	--
510K number	K222991	K193354	K212935	--
Elements of
comparison	Subject Device	Predicate Device I	Predicate Device II	Comparison
Product Name	Air Compression LegMassagerBMK-701	Air Compression TherapyDeviceS9019	Air Pressure Foot MassagerSM-512F	--
ClassificationName	Pow ered inflatable tubemassager	Pow ered inflatable tubemassager	Pow ered inflatable tubemassager	--
RegulationClass	2	2	2	--
Product code	IRP	IRP	IRP	--
RegulationNumber	21 CFR 890.5650	21 CFR 890.5650	21 CFR 890.5650	--
OTC & Rx	OTC	OTC	OTC	Same
Indications forUse	Air Compression LegMassager is indicated for thetemporary relief of minormuscle aches and pains andfor temporary increase incirculation to the treated areasin people who are in goodhealth. Air Compression LegMassager simulates kneadingand stroking of tissues byusing an inflatable garment.	The Air Compression TherapyDevice is indicated for thetemporary relief of minormuscle aches and pains andfor temporary increase incirculation to the treatedareas in people w ho are ingood health. The AirCompression Therapy Devicesimulates kneading andstroking of tissues by usingan inflatable garment.	Air Pressure Foot Massager isintended to temporarily relieveminor muscle aches and/orpains, and to temporarilyincrease circulation to thetreated areas.	MinordifferenceNote 1
Pow er Source	Input: AC100-240V, 50/60HzOutput: DC 13.5V, 1AInternal battery: 11.1V,1000mAh	100~240V 50/60Hz	Voltage: DC5V 1A LithiumBattery: 3.7V, 2400mah	MinordifferenceNote 2
Pow erconsumption	13.5 W	12W	5W	MinordifferenceNote 2
Dimensions(WHD)	2155070 mm	10.25.9 25.6 inch	2115550mm	MinordifferenceNote 2
Photo	Image: Air Compression Leg Massager	Image: Air Compression Therapy Device	Not publicly available	MinordifferenceNote 2
Weight	2.0 Kg (4.4pounds)	4.6 pounds	1.15±0.1kg	MinordifferenceNote 2
HousingMaterials	Molded ABS enclosure	Molded ABS enclosure	Not publicly available	Same
SleevesDimensions	Leg Wrap: 730*468 mm	Leg Wrap: 730*260 mm	340365360mm	Minordifference
Elements ofcomparison	Subject Device	Predicate Device I	Predicate Device II	Comparison
	Image: Subject Device	Image: Predicate Device I		Note 3
Application area	Leg (feet, calves)	Leg (feet, calve, thigh)	Feet	MinordifferenceNote 3
Number ofChambers	2-chamber	3-chamber	2-chamber	MinordifferenceNote 3
SleeveMaterials	Dacron	Nylon with a Polyurethanelaminate	Terylene	MinordifferenceNote 3
Mode ofCompression	Sequential	Sequential / Peristaltic	Sequential	Same
Air PressureLevel	Low level: 120mmHgMedium level: 170mmHgHigh level: 210mmHgError range: ±25mmHg	Low level: 150mmHg;Mid level: 185mmHg;High Level: 215mmHgError range: ±25mmHg	30-110mmHg	MinordifferenceNote 4
Treatment Time	15 minutes	20 minutes	0-30min, default as 15min	MinordifferenceNote 5
Inflation time	5 – 18 s	3 – 30 s	Not publicly available	MinordifferenceNote 6
Keep time	2 - 5 s	1 - 5s	Not publicly available
Deflation time	2 – 5 s	1 - 5s	Not publicly available
Cycle time	Range of 26 sec to 1 min 29sec	Range of 25 sec to 3 min 40sec	Not publicly available
Work Mode	Mode 1:The model is divided intothree processes. The firstprocess is starting with footchamber inflates and holdsthe air until the calf chamberis compressed. Then deflatessimultaneously. The secondprocess is starting with footchamber inflates and holdsthe air until the calf chamber	Mode 1:Starting with the foot chamberand progressing up the thighchamber, each sectioncompresses and the pressuregradually rises to the pre-determined air pressure level,then decompresses and theair pressure drops.Once the thigh sectiondecompresses, the cycle	Mode 1The model is divided into twoprocesses, the first processincludes inflating, deflatingand holding pressure. Theinflating sequence of airchambers of sleeves is: Thechamber No.(1) Inflate andkeep pressure three times,deflated, Then the chamber	MinordifferenceNote 6
Elements of	Subject Device	Predicate Device I	Predicate Device II	Comparison
comparison
	is compressed. Then calfchamber deflates, and finallyfoot chamber deflates. Thethird process is starting withcalf chamber inflates anddeflates then.Mode 1 follows this pressuresequence: Foot → Foot + Calf→ Interval → Foot → Foot +Calf → Foot → Interval → CalfMode 2:In this model, foot chamberand calf chamber are inflatedand deflated at the same time.Mode 2 follows this pressuresequence:Foot + Calf → Interval → Foot+ CalfThe inflating and deflatingtime are different according tothe intensity selected.	begins again. Mode 1 followsthis pressure sequence:Image: pressure sequence diagramMode 2:Starting with the foot chamberand progressing up the thigh,each section compresses andthe pressure gradually rises tothe pre-determined airpressure level, holds the airuntil the entire garment iscompressed. All three sectionsthen decompresssimultaneously and the airpressure drops, then cyclebegins again. Mode 2 followsthis pressure sequence:Image: pressure sequence diagramMode 3:include two stage, stage 1: itworks according to the methodof mode 1, after the stage 1 iscompleted, it goes to stage2(working according to themethod of mode 2) withoutinterruption time until finish thestage 2, then enter next cyclewithout interruption. Thepressure sequence of mode 3combines mode 1 and mode 2	No ② inflate and keeppressure three times, deflated.In the second process, the airpump is always opened, andthe air is inflated and deflatedaccording to the followinginflating sequence: ① ②②-①-②-①-②-①-①-②-①-②-①-②-①②①-②-①The inflating time is differentaccording to the intensityselected.Mode 2In this model, at first, thechamber No. ① inflate andkeep pressure four times, thenchamber No. ①② areinflated and deflated at thesame time. Mode 3The chamber No. ①② areinflated and deflated at thesame time, Then the cyclerepeats
Noise level	≤ 65 dB	≤ 65 dB	Not publicly available	Same
Patient contact	Non-conductive appliances	Non-conductive appliances	Not publicly available	Same
Elements ofcomparison	Subject Device	Predicate Device I	Predicate Device II	Verdict
Software/FirmwareMicroprocessorControl	Microprocessor	Microprocessor	Not publicly available	Same
Technology	Compressor and valvesystem which sequentiallyinflates cells of appliance	Not publicly available	Compressor and valve systemwhich sequentially inflatescells of appliance	Same
Safety Features	Power button allows user tostop therapy session at anytime	Standby button allows user tostop therapy session at anytime	Not publicly available	Same
Operatingenvironment	Temperature: 5°C-40°CHumidity: 5%-90% non-condensing	Temperature: 5°C-40°CHumidity: 5%-90% non-condensing	Not publicly available	Same
Transportation &Storageenvironment	Temperature: -20°C~55°CHumidity: 5%-90%noncondensingAtmospheric Pressure: 75-106kPa	Temperature: 20°C~55°CHumidity: 5%-90%noncondensingAtmospheric Pressure: 75-106kPa	Not publicly available	MinordifferenceNote 2
Electrical safety,EMC	ANSI/AAMI ES60601-1IEC 60601-1-2IEC 60601-1-11IEC 61233	ES 60601-1IEC 60601-1-2IEC 60601-1-11	IEC 60601-1IEC 60601-1-2IEC 60601-1-11IEC 61233	Same
Biocompatibility	ISO 10993-5ISO 10993-10	ISO 10993-5ISO 10993-10	ISO 10993-5ISO 10993-10	Same

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Comparison in Detail(s):

Note 1

Although there are minor differences in the indications for use when compared to the predicate devices, the intended use is the same. This difference does not affect the safety and effectiveness.

Note 2

Although the subject device design and specification parameter between the predicate devices and subject device are different, all complied with the 60601-1 standard. So the differences on such parameters (power, dimensions, appearance,) do not affect the safety and effectiveness.

Note 3

Although the subject device provides 2-chamber wraps for the feet and calves area, which are differents in size and appearance when compared to the predicate devices, the chamber number and applicable body areas are included in the predicate devices, and the material also complies with the applicable ISO 10993-5 and ISO 10993-10 standards. Therefore, the difference does not impact safety and effectiveness.

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Note 4

Although the pressure range of subject device is different than the predicate devices, the range is contained within the predicate devices, so the difference would not impact safety and effectiveness.

Note 5

The treatment time of subject device is 15 minutes, this is similarto both predicate devices and within the range outlined for predicate device II. The user can choose the frequency of treatment and discontinue treatment, so the difference of treatment time would not impact safety and effectiveness.

Note 6

Although the subject device provides 2 work modes, which are not completely the same as the predicate devices, the modes of subject device only have differences in the inflatable order of the different chambers. The treatment pressure range are the same under the different modes, so the different modes would not impact safety and effectiveness.

8. Summary for clinical test

No Clinical Test conducted.

9. Conclusion

The subject device Air Compression Leg Massager has the same intended use as the predicate devices. The few differences outlined do not affect the safety and effectiveness of the subject device when compared to the noted predicate devices. Thus, the subject device is substantially equivalent to the predicate devices.

Regulation Number and Section

§ 890.5650 Powered inflatable tube massager.

(a)
Identification. A powered inflatable tube massager is a powered device intended for medical purposes, such as to relieve minor muscle aches and pains and to increase circulation. It simulates kneading and stroking of tissues with the hands by use of an inflatable pressure cuff.(b)
Classification. Class II (performance standards).