Air Compression Therapy Device, model: ST-502

K213745 · Shenzhen Future Electronic Co., Ltd. · IRP · Mar 31, 2022 · Physical Medicine

Device Facts

• Record ID: K213745
• Device Name: Air Compression Therapy Device, model: ST-502
• Applicant: Shenzhen Future Electronic Co., Ltd.
• Product Code: IRP · Physical Medicine
• Decision Date: Mar 31, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5650
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Air Compression Therapy Device(model: ST-502) is indicated for the temporary relief of minor muscle aches and pains and for temporary increase in circulation to the treated areas in good health. The Air Compression Therapy Device (model: ST-502) simulates kneading and stroking of tissues by using an inflatable garment.

Device Story

Air Compression Therapy Device (ST-502) is a powered inflatable tube massager for home, clinic, or athlete training use. Device consists of a control unit (air pump, pressure sensor, microprocessor) connected via hoses to leg sleeves with three compression chambers. User operates via interface buttons (Power, Intensity, Mode) to select therapy parameters. Device inflates/deflates chambers sequentially or peristaltically to simulate kneading/stroking of tissues. Microprocessor controls timing and pressure (0-240 mmHg) based on sensor feedback. Once target pressure is reached, device deflates via internal valve. Intended to provide temporary relief of minor muscle aches and pains and increase local circulation. Benefits include non-invasive muscle recovery and circulation support.

Clinical Evidence

No clinical data. Bench testing only, including electrical safety (ANSI/AAMI ES60601-1), electromagnetic compatibility (IEC 60601-1-2), and biocompatibility (ISO 10993-5, ISO 10993-10).

Technological Characteristics

Powered inflatable tube massager; 3-chamber leg sleeves; ABS plastic enclosure; microprocessor-controlled air pump; 100-240V AC power; 0-240 mmHg pressure range; 3 modes (sequential/peristaltic); software-controlled timing/pressure; biocompatible sleeve materials (polyester/nylon); compliant with ANSI/AAMI ES60601-1, IEC 60601-1-2, ISO 10993, and IEC 62304.

Indications for Use

Indicated for adults in good health for temporary relief of minor muscle aches and pains and temporary increase in circulation to treated areas (low limbs).

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, model: S9019 (K193354)

Submission Summary (Full Text)

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March 31, 2022

Shenzhen Future Electronic Co., Ltd % You Yijie Manager Qimmiq Medical Consulting Service Co., Ltd. RM.1711, Building K NO.101 Science Ave International Creative Valley Guangzhou, Guangdong 510663 China

Re: K213745

Trade/Device Name: Air Compression Therapy Device, model: ST-502 Regulation Number: 21 CFR 890.5650 Regulation Name: Powered Inflatable Tube Massager Regulatory Class: Class II Product Code: IRP Dated: February 2, 2022 Received: February 2, 2022

Dear You Yijie:

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 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

#### Indications for Use

510(k) Number (if known)

K213745

Device Name

Air Compression Therapy Device, model: ST-502

Indications for Use (Describe)

The Air Compression Therapy Device(model: ST-502) is indicated for the temporary relief of minor muscle aches and pains and for temporary increase in circulation to the treated areas in good health. The Air Compression Therapy Device (model: ST-502) 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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# 510(k) Summary — K213745

### 1. Submitter's Information

#### Establishment Registration Information

Name: SHENZHEN FUTURE ELECTRONIC CO., LTD. Address: Bldg B. Qiangchengda Industrial Park, No. 30, Youtian Road, Longgang SHENZHEN Guangdong, CN 518116

#### Contact Person of applicant

Name: Zhang Benrong Address: Room 301-302, No.15 HanchengRoad, Qingdao Free Trade Zone, Shandong, China, 266555 TEL: [phone] Email: [e-mail]

#### Contact Person of the Submission:

Name: Yijie You Address: RM.1711, Building K, NO.101 Science Ave International Creative Valley Development Zone, Guangzhou China TEL: [phone] FAX: [phone] Email: [e-mail]

Date prepared: Nov. 15, 2021

### 2. Device Information

| Trade Name: | Air Compression Therapy Device |
|----------------------|-----------------------------------|
| Model: | ST-502 |
| Classification name: | Massager, Powered Inflatable Tube |
| Review panel: | Physical Medicine |
| Product code: | IRP |
| Regulation Class: | II |
| Regulation Number: | 21CFR890.5650 |

### 3. Predicate Device Information

#### Predicate device:

510(k) submitter/holder: Shenzhen Dongjilian Electronics Co., Ltd.

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| 510(K) Number: | K193354 |
|----------------------|-----------------------------------|
| Trade Name: | Air Compression Therapy Device |
| Model: | S9019 |
| Classification name: | Massager, Powered Inflatable Tube |
| Review panel: | Physical Medicine |
| Product code: | IRP |
| Regulation Class: | II |
| Regulation Number: | 21CFR890.5650 |

### 4. Device description

Air Compression Therapy Device, model: ST-502 is a powered inflatable tube massager. The Air Compression Therapy Device, model: ST-502 is consists of an air pump, air pressure sensor, leg sleeves and adapter. The air pump, air pressure sensor and control components are protectively housed in a plastic case of the control unit. The control unit is connected to the dedicated leg sleeves via a series of hoses; each leg sleeve has 3 compression chambers. The Air Compression Therapy Device, model: ST-502 utilizes the pneumatically controlled leg sleeves actuated by an electronically controlled air pump unit.

The "Power" button, "Intensity" button, "Mode" button and LED indicators/displays provide for user interface. There is also a port for connecting the AC adapter plug.

The leg sleeves consist of air pipes and three airbags encased inside a soft medical fabric for increased patient comfort and biocompatibility compliance.

In operation, the user simply turns the power on via the "Power" button. And the user presses the "Intensity" button, "Mode" button to adjust the pressure intensity and working mode of the device as the needs of users.

The compression massage direction is from foot room and push up the thighs. By inflating the air chambers sequentially and then deflating as one cycle, the pressure can be adjusted to avoid any discomfort to the patient. The leg sleeves work under the action of sensor and microprocessor. Software controls the timing and pressure reflected by the sensor, cycling airflow into and out of the sleeves to compress body.

During in the working condition, once the leg sleeves pressure of the airbags reach the proper level(240mmHg), the device is turned off, and the leg sleeves deflates to the ambient pressure through a valve inside the plastic case.

Environment of use of the device: Clinics, hospital, athlete training, and home environments

#### Principle of operation:

The control unit is connected to the leg sleeves via hose. The control unit contains an air pump, pressing "Power" button to begin normal treatment status, the air pump will pump air into leg sleeves with stetted rhythm though air pipe, the sleeve fits on the low limbs and provide therapy.

### 5. Indications for Use

The Air Compression Therapy Device (model: ST-502) is indicated for the temporary relief of minor

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muscle aches and pains and for temporary increase in circulation to the treated areas in people who are in good health. The Air Compression Therapy Device (model: ST-502) simulates kneading and stroking of tissues by using an inflatable garment.

## 6. Summary of technological characteristics of device compared to the

| SE<br>Comparisons | Subject device<br>(Air Compression Therapy<br>Device,<br>model: ST-502) | Primary predicate device<br>(Shenzhen Dongjilian<br>Electronics Co.,Ltd.<br>Air Compression Therapy Device,<br>Model: S9019) | Discussion of<br>difference | |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------|
| 510K Number | K213745 | K193354 | / | |
| Classification | 21 CFR890.5650 | 21 CFR890.5650 | Same | |
| Product Code | IRP | IRP | Same | |
| FDA Class | II | II | Same | |
| Indications for Use | The Air Compression Therapy<br>Device (model: ST-502) is indicated<br>for the temporary relief of minor<br>muscle aches and pains and for<br>temporary increase in circulation to<br>the treated areas in people who are<br>in good health. The Air<br>Compression Therapy Device<br>(model: ST-502) simulates kneading<br>and stroking of tissues by using an<br>inflatable garment. | The Air Compression Therapy<br>Device is indicated for the<br>temporary relief of minor muscle<br>aches and pains and for<br>temporary increase in circulation to<br>the treated areas in people who are<br>in good health. The Air<br>Compression Therapy<br>Device simulates kneading and<br>stroking of tissues by using an<br>inflatable garment. | Same | |
| Over-The-Counter<br>Use | Yes | Yes | Same | |
| Model | ST-502 | S9019 | / | |
| Treatment<br>area/Structure of<br>Sleeves | Low limbs (Foot, calf and upper leg) | Low limbs (Foot, calf and upper leg) | Same | |
| Environment of Use | Clinics, hospital, athlete training,<br>and home environments | Clinics, hospital, athlete training,<br>and home environments | Same | |
| Patient Population | Adult | Adult | Same | |
| Power source | 100-240V, 50-60Hz | 100-240V 50/60Hz | Same | |
| Power Consumption | 12w | 12W | Same | |
| SW/Firmware/<br>Microprocessor<br>Control | Microprocessor | Microprocessor | Same | |
| Therapy Time | 20 mins | 20 minutes | Same | |
| Output pressure<br>range | 0~240 mmHg | 0~240 mmHg | Same | |
| Air pressure Level<br>/Compression levels | 3 levels settings:<br>low level:150mmHg;<br>Medium level:185mmHg;<br>High Level: 215mmHg | 3 levels settings:<br>low level:150mmHg;<br>Mid level:185mmHg;<br>High Level: 215mmHg | Same | |
| Pressure error<br>range | $\pm$ 25mmHg | $\pm$ 25mmHg | Same | |
| Inflation time | 3-30s | 3-30s | Same | |
| Keep time | 1-5s | 1-5s | Same | |
| Deflation time | 1-5s | 1-5s | Same | |
| Mode types | Sequential/ Peristaltic | Sequential/ Peristaltic | Same | |
| Cycle time | 25 seconds to 3 minutes and 40<br>seconds | Range of 25 sec to 3 min 40 sec | Same | |
| Number of<br>chambers | 3 Chambers | 3 Chambers | Same | |
| Number of<br>treatment mode | 3 modes | 3 modes | Same | |
| Modes (visual<br>description) | M1:<br>Start in the foot room and push<br>up the thighs, the pressure<br>gradually rises to a<br>predetermined pressure level<br>with each compression, then<br>depressurizes and the pressure<br>drops. Once the thighs are<br>decompressed, the circulation<br>begins again.<br>Pattern 1 follow this stress<br>sequence:<br>Image: Pattern 1 stress sequence<br>M2:<br>Starting in the foot chamber,<br>push up the thighs, and with<br>each compression, the pressure<br>gradually rises to a<br>predetermined air pressure level,<br>holding the air until the entire<br>garment is compressed. All three<br>parts decompress | Mode 1:<br>Starting with the foot chamber and<br>progressing up the thigh chamber,<br>each section compresses and the<br>pressure gradually rises to the pre-<br>determined air pressure level, then<br>decompresses and the air pressure<br>drops.<br>Once the thigh section<br>decompresses, the cycle begins<br>again.<br>Mode 1 follows this pressure<br>sequence:<br>Image: Mode 1 pressure sequence<br>Mode 2:<br>Starting with the foot chamber and<br>progressing up the thigh, each<br>section compresses and the<br>pressure gradually rises to the pre-<br>determined air pressure level, holds<br>the air until the entire garment is<br>compressed. All three sections then | Same | |
| | | | | |
| | | simultaneously, air pressure<br>drops, and the circulation begins<br>again.<br>Pattern 2 follow this pressure<br>sequence:<br>Image: Pressure sequence diagram | decompress simultaneously and the<br>air pressure drops, then cycle begins<br>again.<br>Mode 2 follows this pressure<br>sequence<br>Image: Pressure sequence diagram | |
| | | M3: It consists of two phase.<br>Phase 1: It works as a pattern 1<br>method, and after phase 1 is<br>completed, it continues to phase 2<br>(working as a pattern 2 method)<br>until phase 2 is completed, and<br>then continues to the next cycle<br>without interruption.<br>The pressure sequence of mode 3<br>is combined with mode 1 and mode<br>2. | Mode 3:<br>include two stage, stage 1: it works<br>according to the method of mode 1,<br>after the stage 1 is completed, it go<br>to stage 2(working according to the<br>method of mode 2) without<br>interruption time until finish the stage<br>2, then enter next cycle without<br>interruption .<br>Mode1 $\rightleftharpoons$ Mode2<br>The pressure sequence of mode 3<br>combines mode 1 and mode 2. | |
| Noise level | $\leq$ 65db | | $\leq$ 65dB | Same |
| Sleeve Material | Material of memory cloth: 100%<br>polyester<br>material Velcro(loops):<br>nylon70%, polyester 30%<br>Velcro (hooks): 100% nylon | | Nylon with a Polyurethane laminate | Different<br>(Discussion is<br>indicated in D1) |
| Housing Materials | Molded ABS enclosure | | Molded ABS enclosure | Same |
| Patient contact | Non-conductive attachments | | Non-conductive attachments | Same |
| Size and<br>appearance | L215*W65*H51mm | | 10.2x5.9×25.6<br>(in ) | Different<br>(Discussion is<br>indicated in D2) |
| | |…