Leg and Foot Air Wave Pressure Therapy Device

K223464 · Zhangzhou Easepal Innovation CO , Ltd. · IRP · Mar 14, 2023 · Physical Medicine

Device Facts

• Record ID: K223464
• Device Name: Leg and Foot Air Wave Pressure Therapy Device
• Applicant: Zhangzhou Easepal Innovation CO , Ltd.
• Product Code: IRP · Physical Medicine
• Decision Date: Mar 14, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5650
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Leg and Foot Air Wave Pressure Therapy Device EP-1129 is intended for the temporary relief of minor muscle aches and pains and for the temporary increase in circulation to the treated areas in people who are in good health, it can simulate kneading and stroking of tissues by using an inflatable garment.

Device Story

Device is a powered inflatable tube massager for home use by adults. System comprises a main unit with an air compressor, intermittent pneumatic controller, and 3-chamber sleeves (leg/foot) connected via hose. Powered by AC or internal lithium-ion battery. Device operates by sequentially inflating and deflating air chambers to simulate manual kneading and stroking. User selects from three compression modes and four pressure levels (90-225 mmHg). Output is mechanical pressure applied to limbs. Intended to provide temporary relief of minor muscle aches/pains and increase local circulation. Healthcare provider does not operate; device is for OTC use. Benefits include muscle relaxation and improved circulation.

Clinical Evidence

No clinical data. Substantial equivalence established via bench testing, including electrical safety (ANSI/AAMI ES60601-1), electromagnetic compatibility (IEC 60601-1-2), home healthcare environment requirements (IEC 60601-1-11), battery safety (IEC 62133-2), and usability/human factors validation.

Technological Characteristics

Powered inflatable tube massager; 3-chamber sleeves made of tribute satin and Oxford cloth. Microprocessor-controlled compressor and valve system. Energy source: AC100-240V or internal lithium-ion battery. Dimensions: 340x210x850mm. Pressure range: 90-225 mmHg. Connectivity: None. Sterilization: Not applicable.

Indications for Use

Indicated for adults in good health for temporary relief of minor muscle aches/pains and temporary increase in local circulation via simulated kneading/stroking of tissues using inflatable garments.

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)

Reference Devices

• Ceragem Automatic Thermal Massager, Model CGM MB-1701 & CGM MB-1702 (K220572)

Submission Summary (Full Text)

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March 14, 2023

Zhangzhou Easepal Innovation Co Ltd. % Jet Li Regulation Manager Guangzhou KEDA Biological Tech Co., Ltd. 6F, No.1 TianTai road, Science City, LuoGang District GuangZhou City, China Guangzhou, Guangdong 510000 China

Re: K223464

Trade/Device Name: Leg and Foot Air Wave Pressure Therapy Device Regulation Number: 21 CFR 890.5650 Regulation Name: Powered Inflatable Tube Massager Regulatory Class: Class II Product Code: IRP Dated: March 3, 2023 Received: March 3, 2023

Dear Jet Li:

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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

# Heather L. Dean -S

Heather Dean, PhD Assistant Director, 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) K223464

Device Name

Leg and Foot Air Wave Pressure Therapy Device

Indications for Use (Describe)

Leg and Foot Air Wave Pressure Therapy Device EP-1129 is intended for the temporary relief of minor muscle aches and pains and for the temporary increase in circulation to the treated areas in pood health, it can simulate 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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## 510(k) Summary K223464.

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements according to 21 CFR 807.92 (c), and there were no prior submissions for the subject device.

#### 1. Submitter Information

Sponsor: ZHANGZHOU EASEPALINNOVATION CO., LTD.

Address: No.36 Longkun Road, Hongjian Village, Jiaomei Town, Zhangzhou Taiwanese Investment

Zone, Fujian CHINA 363000

Contact Person: Xu Zibing

Title: Quality Manager

Phone: [phone]

E-mail: [e-mail]

Application Correspondent: Jet Li Company: Guangzhou KEDA Biological Technology Co., Ltd E-mail: [e-mail] Phone: [phone] Address: 6F, No.1 TianTairoad, Science City, LuoGang District, GuangZhou City, China

#### 2. Subject Device Information

Type of 510(k) submission: Traditional Common Name: Leg and Foot Air Wave Pressure Therapy Device Model: EP-1129 Classification Name: Powered inflatable tube massager Review Panel: Physical Medicine Product Code: IRP

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Regulation Number: 21 CFR 890.5650

Regulation Class: 2

| Item | Predicate Device | Reference Device |
|-------------------|----------------------------------------------|---------------------------------------------------------------------------|
| Sponsor | Shenzhen Dongjilian Electronics<br>Co., Ltd. | Ceragem International, Inc. |
| Device Name | Air Compression Therapy<br>Device | Ceragem Automatic Thermal<br>Massager, Model CGM MB-1701 &<br>CGM MB-1702 |
| 510(k) Number | K193354 | K220572 |
| Product Code | IRP | IRP |
| Regulation Number | 21 CFR 890.5650 | 21 CFR 890.5880,<br>21 CFR 890.5650 |
| Regulation Class | 2 | 2 |

#### 3. Predicate and Reference Device Information

### 4. Device Description

Leg and Foot Air Wave Pressure Therapy Device EP-1129 is a powered inflatable tube massager, comprised of an air compressor with intermittent pneumatic controller. 3-chamber sleeves covered with polyester fiber, and a connectable hose for connecting the device to the sleeves.

The device can be powered by an external power supply, or be powered by an internal lithium ion battery. The sleeves have 3-chambers and different applicable body areas, such as the Foot Leg. The sleeves can be inflating and deflating sequentially to apply the circulating pressure on the target body areas which controlled by the main unit.

The device simulates manual kneading and stroking of tissues by sequential inflated sleeves, to temporarily relieve minor muscle aches and/or pains and to temporarily increase circulation to the treated areas. It is to be used by adults who are in good health.

The recommended treatment time is 15 minutes per time, and recommend to take one time treatment every two days.

#### 5. Intended Use/Indication for use

Leg and Foot Air Wave Pressure Therapy Device EP-1129 is intended for the temporary relief of minor muscle aches and pains and for the temporary increase in circulation to the treated areas in people who are in good heath, it can simulate kneading and stroking of tissues by using an inflatable garment.

### 6. TestSummary

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## Non Clinical testing:

The Leg and Foot Air Wave Pressure Therapy Device has been evaluated the safety and performance by lab bench testing according to the following standards:

- -ANSI/AAMI ES60601-1: 2005+A1:2012; AMD2:2021, Medical Electrical Equipment - Part 1: General Requirements for Safety,
- -IEC 60601-1-2: 2014, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility -Requirements and tests
- -IEC 60601-1-11 Edition 2.0 2015-01, 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,
- -IEC 62133-2:2017, Secondary cells and batteries containing alkaline or other non-acid electrolytes - Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications- Part 2: Lithium systems
- -The software was validated according to the FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.

The device also was verified with the following benching testing and usability study:

- Product service life verification -
- -Burst Strength Test
- Product performance testing after reliability testing -

Tests results are supporting all labeling claims in order to establish substantial equivalency.

Usability Study was completed in the subject device:

A human Factors Validation Testing was done to evaluate the HFE/ UE concerns, including label comprehension/self-selection and usability/user interface studies.

Clinical testing: Clinical testing is not necessary for the subject device.

### 7. Comparison to Predicate Device

Compare with predicate device, the subject device is very similar in design principle, intended use, indications for use, functions, material and the applicable standards. The differences between subject device and predicate device do not raise any new questions of safety or effectiveness. See the below form.

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| Elements of<br>comparison | Subject Device | Predicate Device | Reference Device |
|----------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | ZHANGZHOU EASEPAL<br>INNOVATION CO., LTD. | Shenzhen Dongjilian Electronics Co., Ltd. | Ceragem International, Inc. |
| 510K number | K223464 | K193354 | K220572 |
| Product Name | Leg and Foot Air Wave Pressure<br>Therapy Device<br>Model EP-1129 | Air Compression Therapy Device (S9019) | Ceragem Automatic Thermal Massager, Model<br>CGM MB-1701 & CGM MB-1702 |
| Regulation Number | 21 CFR 890.5650 | 21 CFR 890.5650 | 21 CFR 890.5880,<br>21 CFR 890.5650 |
| Classification Name | Powered inflatable tube massager | Powered inflatable tube massager | Powered inflatable tube massager |
| Regulation Class | 2 | 2 | 2 |
| OTC & Rx | OTC | OTC | OTC |
| Indications for Use | Leg and Foot Air Wave Pressure<br>Therapy Device EP-1129 is<br>intended for the temporary relief of<br>minor muscle aches and pains and<br>for the temporary increase in<br>circulation to the treated areas in<br>people who are in good health, it<br>can simulate kneading and<br>stroking of tissues by using an<br>inflatable garment. | The Air Compression Therapy Device is<br>indicated for the temporary relief of minor<br>muscle aches and pains and for<br>temporary increase in circulation to the<br>treated areas in people who are in good<br>health. The Air Compression Therapy<br>Device simulates kneading and stroking of<br>tissues by using an inflatable garment. | The intended use of the Ceragem Automatic<br>Thermal Massager, Model CGM MB-1701 & CGM<br>MB-1702 is to provide muscle relaxation therapy by<br>delivering heat and soothing massage.<br>Additionally, the product provides topical radiant<br>infrared heat for:<br>-Temporary relief of minor muscle and joint pain<br>stiffness<br>-Temporary relief of minor joint pain associated with<br>arthritis<br>-Temporary increase in local circulation where<br>applied<br>- Relaxation of muscles<br>The Air Cell Massager (only CGM MB-1701) is<br>indicated for the temporary relief of minor muscle<br>aches and pains and for temporary increase in |
| Elements of<br>comparison | Subject Device | Predicate Device | Reference Device |
| Power Source | AC100-240V, 50/60Hz | 100~240V 50/60Hz | 100-127Vac 50/60Hz |
| Power consumption | 11.1W | 12W | 480VA |
| Dimensions (W*H*D) | 340*210*850mm | 10.2*5.9*25.6 (in) | / |
| Photo | Image: Subject Device Remote | Image: Predicate Device Remote | / |
| Weight | 2.0 Kg(4.4pounds) | 4.6 pounds | / |
| Size and appearance<br>of sleeves (leg part) | Image: Subject Device Leg Sleeves<br>One size: 85*34 cm | Image: Predicate Device Leg Sleeves<br>One size: 73*26 cm | Image: Reference Device Leg Sleeve<br>Leg:<br>One size: 28*58.4cm |
| Inflation time | 20-50 s | 3-30 s | 1 min ~ 1 min 30 s |
| Keep time | 1-3 s | 1-5 s | 1 ~ 13 s |
| Elements of<br>comparison | Subject Device | Predicate Device | Reference Device |
| Deflation time | 5 s | 1-5 s | 1 ~ 10 s |
| Cycle time | 30 seconds to 3 mins | Range of 25 sec to 3 min 40 sec | Range of 28 sec to 39 sec |
| Number of Chambers | 3 Chambers | 3 Chambers | 4 Chambers |
| Sleeve Materials | Tribute satin and Oxford cloth | Nylon with a Polyurethane laminate | Oxford and Nylon |
| Mode of Compression | Sequential | Sequential | Sequential |
| Device Pressure range | 90-225mmHg | 0-240 mmHg | 48~240 mmHg |
| Air pressure level<br>/Compression levels | 4 levels settings:<br>Level 1:90mmHg;<br>Level 2:135mmHg;<br>Level 3: 188mmHg<br>Level 4: 225mmHg | 3 levels settings:<br>low level:150mmHg;<br>Mid level:185mmHg;<br>High Level: 215mmHg | 9 levels settings:<br>Level 1 : 48mmHg<br>Level 2 : 72mmHg<br>Level 3 : 96mmHg<br>Level 4 : 120mmHg<br>Level 5 : 144mmHg<br>Level 6 : 168mmHg<br>Level 7 : 192mmHg<br>Level 8 : 216mmHg<br>Level 9 : 240mmHg…