Air Compression Leg Massager (K-705)

K242140 · Jiale Health Technology Shenzhen Co., Ltd. · IRP · Mar 17, 2025 · Physical Medicine

Device Facts

• Record ID: K242140
• Device Name: Air Compression Leg Massager (K-705)
• Applicant: Jiale Health Technology Shenzhen Co., Ltd.
• Product Code: IRP · Physical Medicine
• Decision Date: Mar 17, 2025
• 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 a controller unit (housing air pump, battery, control electronics) and inflatable leg wraps. User operates device via buttons on controller interface. System uses pneumatically controlled air pump to inflate/deflate 2-chamber bladders within wraps, simulating kneading/stroking of tissues. Includes optional warming and vibration features. Used by individuals to temporarily relieve minor muscle aches/pains and increase circulation. Healthcare provider/user monitors therapy via LED indicators; session can be stopped at any time via power button. Benefits include muscle relaxation and improved circulation in healthy users.

Clinical Evidence

Bench testing only. No clinical data. Performance supported by biocompatibility testing (ISO 10993-5, -10, -23), electrical safety/EMC (IEC 60601-1, -1-2, -1-11), battery safety (IEC 62133-2), and software verification/validation.

Technological Characteristics

Materials: Nylon polyester (wraps), ABS/PC (controller). Principle: Pneumatic compression via electronically controlled air pump. Energy: Internal 3.7V 2500mAh battery or AC adapter. Form factor: Portable controller with leg wraps. Connectivity: Standalone. Sterilization: Clean, non-sterile. Software: Microprocessor-controlled, rule-based operation.

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 Leg Massager (model: EMK-701) (K222991)

Reference Devices

• JetBoots PRO Plus (K241256)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

March 17, 2025

Jiale Health Technology Shenzhen Co., Ltd. % Youshan Gong RA Specialist Feiying Drug & Medical Consulting Technical Service Group Rm 2401 Zhenye International Business Center, No. 3101-90, Qianhai Road Shenzhen, Guangdong 518052 China

Re: K242140

Trade/Device Name: Air Compression Leg Massager (K-705) Regulation Number: 21 CFR 890.5650 Regulation Name: Powered Inflatable Tube Massager Regulatory Class: Class II Product Code: IRP, IRO Dated: January 15, 2025 Received: February 26, 2025

Dear Youshan Gong:

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 (the 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 available 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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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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

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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 | |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------|
| Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions. | K242140 |
| | ? |
| Please provide the device trade name(s). | |
| | Air Compression Leg Massager (K-705) |
| | ? |
| Please provide your Indications for Use below. | |
| 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. | |
| | ? |
| Please select the types of uses (select one or both, as applicable). | <input type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) |
| | <input checked="" type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) |
| | ? |

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## 510(k) Summary K242140

## "510(k) Summary" as required by 21 CFR Part 807.92.

#### Date Prepared: 2025-3-11

#### I. Submitter

Jiale Health Technology Shenzhen Co., Ltd. 201, Builing A, No, 17, Guangjin Road, Shapu Community, Songgang Street, Bao 'an District, Shenzhen, China Post code: 518100 Tel.: [phone]

XieLixun General Manager Tel: [phone] E-mail: [e-mail]

#### II. Device

Name of Device: Air Compression Leg Massager Model(s): K-705 Common or Usual Name: Massager, Powered Inflatable Tube Regulation Name: Powered inflatable tube massager Regulatory Class: II Product Code: IRP, IRO Regulation Number: 21 CFR 890.5650, 21 CFR 890.5975

## III. Predicate Device and Reference Device

- Predicate Device A

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| Manufacturer | Predicate Device | 510(k) Number |
|--------------------------------------------------------|--------------------------------------------------|---------------|
| Xiamen Emoka<br>HealthScience&<br>Technology Co., Ltd. | Air Compression Leg<br>Massager (model: EMK-701) | K222991 |

#### Secondary Predicate Device A

| Manufacturer | Reference Device | 510(k) Number |
|----------------|-------------------|---------------|
| THERABODY, Inc | JetBoots PRO Plus | K241256 |

#### IV. Device Description

Air Compression Leg Massager is a portable and rechargeable device. It is intended to be an over-the-counter portable inflatable tube massage system which simulates kneading of tissue with the hards by use of inflatable presure 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 by an electronically controlled air pump unit. A pump, battery and control components are protectively housed in a plastic case of Controller.

Function buttons and light emitting diode (LED) indicators on the user interface. There is a charging port at the bottom of Controller for connecting the alternating current (AC) adapter plug.

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

Air Compression Leg Massager is also capable of providing the warming and vibration, these are included for an improved user experience.

#### V. Indications for Use

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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 of tissues by using an inflatable garment.

#### VI. Materials

| Model | Contacted Component Name | Materials |
|-------|--------------------------|-----------------|
| K-705 | Leg wraps | Nylon polyester |
| | Enclosure of Controller | ABS, PC |

#### VII. Comparison of Technological Characteristics With the Predicate Device

The Air Compression Leg Massager (K-705) has the same intended use as the predicate devices . The technological characteristics such as application area, number of chambers, ar pressure level and treatment time, are similar to the primary predicate device. Any minor differences between the listed primary predicate device and secondary predicate device do no raise any issues of safety or efficacy. Performance data supports that the device is the primary predicate device and secondary predicate device for its intended use.

Therefore, the Air Compression Leg Massager may be found substantially equivalent to its primary predicate device.

| Comparison Elements | Subject Device | Primary Predicate Device | Secondary Predicate Device | Remark |
|---------------------|----------------|--------------------------|----------------------------|--------|
| Model | K-705 | EMK-701 | JetBoots PRO Plus | / |
| 510(k) Number | K242140 | K222991 | K241256 | / |

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| Comparison Elements | Subject Device | Primary Predicate Device | Secondary Predicate Device | Remark |
|--------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|
| Model | K-705 | EMK-701 | JetBoots PRO Plus | / |
| Trade name | Air Compression Leg<br>Massager | Air Compression Leg<br>Massager (model: EMK-<br>701) | JetBoots PRO Plus | / |
| Manufacturer | Jiale Health Technology<br>Shenzhen Co., Ltd. | Xiamen Emoka<br>HealthScience&<br>Technology Co., Ltd. | THERABODY, Inc | / |
| Regulation number | 21 CFR 890.5650<br>21 CFR 890.5975 | 21 CFR 890.5650<br>21 CFR 890.5975 | 21 CFR 890.5650<br>21 CFR 890.5500<br>21 CFR 890.5975 | Same |
| Device class | II | II | II | Same |
| Product code | IRP, IRO | IRP | IRP, ILY, IRO | Same |
| Comparison Elements | Subject Device | Primary Predicate Device | Secondary Predicate Device | Remark |
| Model | K-705 | EMK-701 | JetBoots PRO Plus | / |
| Indication for 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. | Air Compression Leg<br>Massager is indicated for<br>the temporary relief of<br>minor muscle aches and<br>pains and for temporary<br>increase in circulation to the<br>treated areas in people who<br>are in good health. Air<br>Compression Leg Massager<br>simulates kneading and<br>stroking of tissues by using<br>an inflatable garment. | JetBoots PRO Plus is an air<br>compression therapy device<br>intended to provide graduated<br>pressure to the legs. JetBoots PRO<br>Plus is indicated for the temporary<br>relief of minor muscle aches and<br>pains, and for a temporary increase<br>in blood circulation to the treated<br>area in people who are in good<br>health. JetBoots PRO Plus<br>simulates kneading and stroking of<br>tissues by using an inflatable<br>garment. | Same |
| Prescription or OTC | Over-The-Counter Use | Over-The-Counter Use | Over-The-Counter Use | Same |
| Power Source | Input: AC100-240V,50/60HZ<br>Output: DC5V/1A<br>Internal battery: 3.7V<br>2500mAh | Input: AC100-240V,<br>50/60Hz<br>Output: DC 13.5V, 1A<br>Internal battery:<br>11.1V,1000mAh | Power Adapter:<br>AC Input: 100 -240V AC,<br>50/60Hz, DC Output: 15.0V, 4.8A,<br>72W<br>Or<br>Internal Battery | Different |
| Comparison Elements | Subject Device | Primary Predicate Device | Secondary Predicate Device | Remark |
| Model | K-705 | EMK-701 | JetBoots PRO Plus | / |
| Power<br>consumption | 6.5W | 13.5 W | 72W<br>Or<br>Internal Battery | Different |
| Dimensions (W*H*D) | 358*172*67mm | 215*50*70 mm | Console & Compression boot (Lead<br>or Support, deflated and fully<br>extended):<br>• S-size: 36.8in (L) * 5.3in (W) *<br>14.8 (H)<br>• M-size: 42.9in (L) * 5.3in (W) *<br>16.1 (H)<br>• L-size: 46.5in (L) * 5.3in (W) *<br>16.1 (H) | Different |
| Weight | 0.59kg(1.28pounds) | 2.0 Kg (4.4pounds) | S-size: 6.0lb (per boot)<br>M-size: 6.4lb (per boot)<br>L-size: 6.7lb (per boot) | Different |
| Housing<br>Materials | Molded ABS enclosure | Molded ABS enclosure | Molded PC+ABS enclosure | Same |
| Comparison Elements | Subject Device | Primary Predicate Device | Secondary Predicate Device | Remark |
| Model | K-705 | EMK-701 | JetBoots PRO Plus | / |
| Sleeves Dimensions | Leg Wrap: 350*628mm | Leg Wrap: 730*468 mm | Compression boots sleeves attached to consoles.<br>Sleeves (extended) only:<br>S: 80cm (L)* 37.5 cm (H)<br>M: 95cm (L)* 41.0 cm (H)<br>L: 1050cm (L)* 41.0 cm (H) | Different |
| Application area | Leg (calves) | Leg (feet, calves) | Leg (feet, calve) | Different |
| Number of Chambers | 2-chamber | 2-chamber | 4-chamber | Different |
| Sleeve Materials | Nylon polyester | Dacron | Polyether Nylon Fabric | Different |
| Mode of Compression | Sequential | Sequential | No related information | Same |
| Comparison Elements | Subject Device | Primary Predicate Device | Secondary Predicate Device | Remark |
| Model | K-705 | EMK-701 | JetBoots PRO Plus | / |
| Air Pressure<br>Level | Low level: 120mmHg<br>Medium level: 170mmHg<br>High level: 210mmHg<br>Error range: ±25mmHg | Low level: 120mmHg<br>Medium level: 170mmHg<br>High level: 210mmHg<br>Error range: ±25mmHg | 20 – 100 mmHg, steps of 5mm Hg | Same |
| Treatment Time | 15 minutes | 15 minutes | 10min – 60min, steps of 5min for<br>Pneumatic Compression<br>10min – 45min for Infrared LED | Same |
| Inflation time | 2-12s | 5 -18 s | No related information | Different |
| Keep time | 3-6s | 2 - 5 s | 0 – 10 seconds depending on the<br>selected preset. | |
| Deflation time | 1-6s | 2 - 5 s | No related information | |
| Comparison Elements | Subject Device | Primary Predicate Device | Secondary Predicate Device | Remark |
| Model | K-705 | EMK-701 | JetBoots PRO Plus | / |
| Cycle time | Range of 6sec to 1 min 2.0sec | Range of 26 sec to 1 min 29<br>sec | Pause interval between cycles: 15<br>seconds…