Air Compression Leg Massager (model: EMK-701)

K222991 · Xiamen Emoka Health Science & Technology Co., Ltd. · IRP · Mar 15, 2023 · Physical Medicine

Device Facts

• Record ID: K222991
• Device Name: Air Compression Leg Massager (model: EMK-701)
• Applicant: Xiamen Emoka Health Science & Technology Co., Ltd.
• Product Code: IRP · Physical Medicine
• Decision Date: Mar 15, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5650
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

Portable, rechargeable air compression leg massager; intended for OTC use. Device consists of handheld controller with internal pump, battery, and microprocessor; connects via air hoses to leg wraps containing 2-chamber air bladders. User operates via power button and interface; controller inflates/deflates bladders in preset sequences (kneading/stroking simulation). Internal pressure sensor monitors inflation levels; pump stops at target pressure for rest periods. Used in home environment to increase circulation and relieve minor muscle aches. Output is mechanical compression of feet and calves; provides patient comfort via medical fabric wraps. Benefits include temporary pain relief and improved circulation.

Clinical Evidence

No clinical data. Bench testing only, including ANSI/AAMI ES60601-1, IEC 62133-2, IEC 60601-1-2, IEC 60601-1-11, ISO 10993-5, and ISO 10993-10.

Technological Characteristics

Powered inflatable tube massager; 2-chamber air bladders; Dacron medical fabric wraps. Microprocessor-controlled air pump; 11.1V 1000mAh internal battery; AC 100-240V input. Pressure range 120-210 mmHg. Biocompatibility per ISO 10993-5/10. Electrical safety per ANSI/AAMI ES60601-1, IEC 60601-1-2, IEC 60601-1-11. Handheld controller with LED indicators.

Indications for Use

Indicated for temporary relief of minor muscle aches and pains and temporary increase in circulation to treated areas in healthy individuals.

Regulatory Classification

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.

Predicate Devices

• Air Compression Therapy Device (K193354)
• Air Pressure Foot Massager (K212935)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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)

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.

| 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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# 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: [phone]
- � Email: [e-mail]
- 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: [phone]
- � Email: [e-mail]; [e-mail]

#### 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

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

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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 of<br>comparison | Subject Device | Predicate Device I | Predicate Device II | Comparison |
|------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------|
| Manufacturer | Xiamen Emoka Health<br>Science & Technology Co.,<br>Ltd. | Shenzhen Dongjilian<br>Electronics Co., Ltd. | Xiamen Simo Electronic Co.,<br>Ltd | -- |
| 510K number | K222991 | K193354 | K212935 | -- |
| Elements of | | | | |
| comparison | Subject Device | Predicate Device I | Predicate Device II | Comparison |
| Product Name | Air Compression Leg<br>Massager<br>BMK-701 | Air Compression Therapy<br>Device<br>S9019 | Air Pressure Foot Massager<br>SM-512F | -- |
| Classification<br>Name | Pow ered inflatable tube<br>massager | Pow ered inflatable tube<br>massager | Pow ered inflatable tube<br>massager | -- |
| Regulation<br>Class | 2 | 2 | 2 | -- |
| Product code | IRP | IRP | IRP | -- |
| Regulation<br>Number | 21 CFR 890.5650 | 21 CFR 890.5650 | 21 CFR 890.5650 | -- |
| OTC & Rx | OTC | OTC | OTC | Same |
| Indications for<br>Use | Air Compression Leg<br>Massager is indicated for the<br>temporary relief of minor<br>muscle aches and pains and<br>for temporary increase in<br>circulation to the treated areas<br>in people who are in good<br>health. Air Compression Leg<br>Massager simulates kneading<br>and stroking of tissues by<br>using an inflatable garment. | The Air Compression Therapy<br>Device is indicated for the<br>temporary relief of minor<br>muscle aches and pains and<br>for temporary increase in<br>circulation to the treated<br>areas in people w ho are in<br>good health. The Air<br>Compression Therapy Device<br>simulates kneading and<br>stroking of tissues by using<br>an inflatable garment. | Air Pressure Foot Massager is<br>intended to temporarily relieve<br>minor muscle aches and/or<br>pains, and to temporarily<br>increase circulation to the<br>treated areas. | Minor<br>difference<br>Note 1 |
| Pow er Source | Input: AC100-240V, 50/60Hz<br>Output: DC 13.5V, 1A<br>Internal battery: 11.1V,<br>1000mAh | 100~240V 50/60Hz | Voltage: DC5V 1A Lithium<br>Battery: 3.7V, 2400mah | Minor<br>difference<br>Note 2 |
| Pow er<br>consumption | 13.5 W | 12W | 5W | Minor<br>difference<br>Note 2 |
| Dimensions<br>(W*H*D) | 215*50*70 mm | 10.2*5.9 *25.6 inch | 211*55*50mm | Minor<br>difference<br>Note 2 |
| Photo | Image: Air Compression Leg Massager | Image: Air Compression Therapy Device | Not publicly available | Minor<br>difference<br>Note 2 |
| Weight | 2.0 Kg (4.4pounds) | 4.6 pounds | 1.15±0.1kg | Minor<br>difference<br>Note 2 |
| Housing<br>Materials | Molded ABS enclosure | Molded ABS enclosure | Not publicly available | Same |
| Sleeves<br>Dimensions | Leg Wrap: 730*468 mm | Leg Wrap: 730*260 mm | 340*365*360mm | Minor<br>difference |
| Elements of<br>comparison | 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 | Minor<br>difference<br>Note 3 |
| Number of<br>Chambers | 2-chamber | 3-chamber | 2-chamber | Minor<br>difference<br>Note 3 |
| Sleeve<br>Materials | Dacron | Nylon with a Polyurethane<br>laminate | Terylene | Minor<br>difference<br>Note 3 |
| Mode of<br>Compression | Sequential | Sequential / Peristaltic | Sequential | Same |
| Air Pressure<br>Level | Low level: 120mmHg<br>Medium level: 170mmHg<br>High level: 210mmHg<br>Error range: ±25mmHg | Low level: 150mmHg;<br>Mid level: 185mmHg;<br>High Level: 215mmHg<br>Error range: ±25mmHg | 30-110mmHg | Minor<br>difference<br>Note 4 |
| Treatment Time | 15 minutes | 20 minutes | 0-30min, default as 15min | Minor<br>difference<br>Note 5 |
| Inflation time | 5 – 18 s | 3 – 30 s | Not publicly available | Minor<br>difference<br>Note 6 |
| Keep time | 2 - 5 s | 1 - 5s | Not publicly available | |
| Deflation time | 2 – 5 s | 1 - 5s…