Air Compression Therapy Device

K193354 · Shenzhen Dongjilian Electronics Co., Ltd. · IRP · Jun 8, 2020 · Physical Medicine

Device Facts

• Record ID: K193354
• Device Name: Air Compression Therapy Device
• Applicant: Shenzhen Dongjilian Electronics Co., Ltd.
• Product Code: IRP · Physical Medicine
• Decision Date: Jun 8, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5650
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Air Compression Therapy Device 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. The Air Compression Therapy Device simulates kneading and stroking of tissues by using an inflatable garment.

Device Story

Air Compression Therapy Device (S9019) is a powered inflatable tube massager for OTC use in clinics, hospitals, athlete training, or home environments. It consists of an air pump, air pressure sensor, and 3-chambered sleeves connected by hoses. The device uses a microprocessor to control inflation/deflation cycles, simulating kneading and stroking of tissues. It operates in sequential or peristaltic modes, with pressure adjustable up to 240 mmHg. The user controls the session via a standby button. By cycling airflow into and out of the sleeves, the device compresses the lower limbs (foot, calf, thigh) to promote circulation and relieve muscle aches. The system is powered by 100-240V AC. Safety is managed via pressure sensors to prevent overpressure and compliance with electrical/EMC standards.

Clinical Evidence

No clinical test data was used to support the decision of substantial equivalence. Bench testing only.

Technological Characteristics

Materials: Nylon with polyurethane laminate sleeves, molded ABS housing. Sensing: Air pressure sensor. Energy: 100-240V AC, 50/60Hz. Form factor: 10.2 x 5.9 x 25.6 inches. Connectivity: Standalone. Software: Microprocessor-controlled. Standards: ES 60601-1 (Safety), IEC 60601-1-2 (EMC), IEC 60601-1-11 (Home healthcare), ISO 10993-5/10 (Biocompatibility), IEC 62304 (Software), IEC 62366-1 (Usability), ISO 14971 (Risk management).

Indications for Use

Indicated for temporary relief of minor muscle aches/pains and temporary increase in circulation in healthy individuals. Used via inflatable garment.

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

• Rapid Reboot Compression Therapy System (K182668)
• Relaxor Perfect Touch Air Massaging System (K030437)
• NormaTec Pulse and NormaTec Pulse Pro (K160608)

Submission Summary (Full Text)

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June 8, 2020

Shenzhen Dongjilian Electronics Co., Ltd. % Reanny Wang General Manager Shenzhen Reanny Medical Devices Management Consulting Co., Ltd. Room 2012#, Gebu commercial building, Hongxing community, Songgang street Shenzhen, 518105 Cn

Re: K193354

Trade/Device Name: Air Compression Therapy Device Regulation Number: 21 CFR 890.5650 Regulation Name: Powered Inflatable Tube Massager Regulatory Class: Class II Product Code: IRP Dated: May 28, 2020 Received: June 8, 2020

Dear Reanny Wang:

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 (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 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.

Vivek Pinto, PhD Director 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) K193354

Device Name Air Compression Therapy Device

#### Indications for Use (Describe)

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

Prescription Use (Part 21 CFR 801 Subpart D)

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

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# Traditional 510(k) Summary

## K193354

#### 1. Information of Submitter and Correspondent

#### Submitter's information:

| Company Name: | Shenzhen Dongjilian Electronics Co.,Ltd. |
|------------------|-----------------------------------------------------------------------------------------|
| Street Address: | B1/1-5F, Tonglu Industrial Area, 70# Tongxin Road, Tongxin Community, Longgang District |
| City: | Shenzhen |
| State/ Province: | Guangdong |
| Country: | China |
| Telephone: | [phone] |
| Fax: | [phone] |
| Contact Person: | ZHANG HONG |
| Contact Title: | General Manager |
| Contact Email: | [e-mail] |

Date Prepared: May 27, 2020

#### Submission correspondent's information:

Shenzhen Reanny Medical Devices Management Consulting Co., Ltd

- Address: Room 2012#, Gebu commercial building, Hongxing community, Songgang street, Baoan district, Shenzhen 518000, China
Contact Person: Reanny Wang

E-mail: [e-mail]

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Image /page/4/Picture/0 description: The image shows the word "CINCON" in a stylized, bold font. The letters are primarily white with a black outline, giving them a three-dimensional appearance. The "O" in "CINCON" has a red fill, adding a touch of color to the otherwise monochrome design. A registered trademark symbol is present to the right of the word.

Phone: [phone]

#### 2. Device Information

| Trade Name: | Air Compression Therapy Device |
|----------------------|-----------------------------------|
| Model: | S9019 |
| Common Name: | Powered Inflatable Tube Massager |
| Classification Name: | Massager, Powered Inflatable Tube |
| Regulation: | 21 CFR § 890.5650 |
| Device Class: | Class 2 |
| Product Code: | IRP |

#### 3. Identification of Predicate Device(s)

| Manufacturer | Rapid Reboot Recovery<br>Products, LLC | Salton,INC | NormaTec<br>Industries, LP |
|----------------------------|-----------------------------------------------|--------------------------------------------------|------------------------------------------|
| Legally Marketed<br>Device | Rapid Reboot<br>Compression Therapy<br>System | Relaxor Perfect<br>Touch Air Massaging<br>System | NormaTec Pulse and<br>NormaTec Pulse Pro |
| 510(K) Number | K182668 | K030437 | K160608 |

#### 4. Description of Device

Air Compression Therapy Device consists of an air pump, air pressure sensor, and sleeves working together as one unit. The air pump is connected to the dedicated sleeves via a series of hoses; each sleeve has 3 compression chambers. The compression massage direction is from foot to thigh. 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 sleeve works 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.

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Image /page/5/Picture/0 description: The image shows the Cincom logo. The logo is in black and white, with a red square in the middle of the "O". The logo is a stylized version of the word "CINCOM". There is a registered trademark symbol to the right of the logo.

#### Indications for Use 5.

The Air Compression Therapy Device 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. The Air Compression Therapy Device simulates kneading and stroking of tissues by using an inflatable garment.

## 6. Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence are as follows:

#### 6.1 Non-clinical testing

A series of safety and performance tests were conducted on the subject device.

- Product service life
- Software validation
- Electromagnetic compatibility and electrical safety
- Function test

All the test results demonstrate Air Compression Therapy Device meets the requirements of its pre-defined acceptance criteria and intended use, and it is substantially equivalent to the predicate devices.

#### 6.2 Clinical Testing

No clinical test data was used to support the decision of substantial equivalence.

#### 7. Performance Summary

The devices conform to applicable standards as follow table:

| Test Type | Standard Designation<br>Number | FDA Recognition<br>Status | Outcome<br>for Device |
|-----------------------------|--------------------------------|---------------------------|-----------------------|
| Safety | ES 60601-1:2005+<br>A1:2012 | Yes | Conforms |
| EMC | IEC 60601-1-2:2014 | Yes | Conforms |
| Home healthcare environment | IEC 60601-1-11:2015 | Yes | Conforms |

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Image /page/6/Picture/0 description: The image shows the word "CINCOM" in a stylized font. The letters are outlined in white with a black fill, except for the letter "O", which has a red fill. A registered trademark symbol is located to the right of the word.

| Performance | Enterprise standard | Yes | Conforms |
|------------------|----------------------------------------------------|-----|----------|
| Biocompatibility | ISO 10993-10:2010;<br>ISO 10993-5:2009 | Yes | Conforms |
| Software | IEC 62304:2006/A1:2016 | Yes | Conforms |
| Usability | IEC 60601-1-6:<br>2010+A1:2013<br>IEC 62366-1:2015 | Yes | Conforms |
| Risk management | ISO 14971:2007 | Yes | Conforms |

#### 8. Discussion of Comparison to Predicate Devices.

The Air Compression Therapy Device submitted in this 510(k) submission is substantially equivalent in intended use, technological characteristics/ principles of operation, materials, and performance to the cleared Rapid Reboot Compression Therapy System K182668, Relaxor Perfect Touch Air Massaging System K030437, and NormaTec Pulse and NormaTec Pulse Pro K160608. Differences between the subject and predicate devices do not raise new questions of safety and effectiveness.

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Image /page/7/Picture/0 description: The image contains the word "CINCOM" in a stylized, bold font. The letter "O" in "CINCOM" has a red square in the middle. There is a horizontal line below the word, and a registered trademark symbol is located to the right of the word.

| Device | Subject device | Primary Predicate device | Secondary Predicate device | Third Predicate device | Comparison |
|----------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|
| Manufacturer | Shenzhen Dongjilian Electronics Co.,Ltd. | Rapid Reboot Recovery Products, LLC | Salton, Inc | NormaTec Industries, LP | NA |
| 510(K) number | K193354 | K182668 | K030437 | K160608 | NA |
| Model name | S9019 | Rapid Reboot Compression Therapy System | Relaxor Perfect Touch Air Massaging System | NormaTec Pulse and NormaTec Pulse Pro | NA |
| Classification | Class II Device, IRP (21 CFR890.5650) | Class II Device, IRP (21 CFR890.5650) | Class II Device, IRP (21 CFR890.5650) | Class II Device, IRP (21 CFR890.5650) | Same |
| Indications for Use (IFU) | The Air Compression Therapy Device 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. The Air Compression Therapy Device simulates kneading and stroking of tissues by using an inflatable garment. | The Rapid Reboot Compression Therapy System is indicated 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. The Rapid Reboot Compression Therapy System simulates kneading and stroking of tissues by using an inflatable garment. | The Perfect Touch Air Massaging System 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. The Perfect Touch simulates kneading and stroking of tissues by using an inflatable garment. | The NormaTec Pulse and Pulse Pro is an air pressure massager intended to temporarily relieve minor muscle aches and/or pains, and to temporarily increase circulation to the treated areas. | Same |
| Treatment area/Structure of Sleeves | Low limbs (Foot, calf and upper leg) | Leg (including of foot, calf, knee, upper leg);<br>Hip (including of upper legs, glutes, hips, lower back);<br>Arm (including of entire arm, shoulder, upper chest and back) | Leg (including of foot, calf);<br>Back (including of lower and mid back);<br>Arm (including of forearm, lower bicep) | Leg (including of foot, calf, knee, upper leg);<br>Hip (including of upper legs, glutes, hips, lower back);<br>Arm (including of entire arm, shoulder | Same |
| Device | Subject device | Primary Predicate<br>device | Secondary Predicate<br>device | Third Predicate<br>device | Comparison |
| OTC or Rx | OTC | OTC | OTC | OTC<br>(upper chest and<br>back). | Same |
| Environment of<br>Use: | Clinics, hospital,<br>athlete training, and<br>home environments | Clinics, hospital, athlete<br>training, and home<br>environments | Home environment | Clinics, hospital,<br>athlete<br>training, and home<br>environments | Same |
| Power source | 100~240V 50/60Hz | 110V, 60HZ | 120V, 60Hz | 100- 240 VAC input | Same |
| Power<br>Consumption | 12W | 30W | 26W | 14W | Similar<br>Note 3 |
| SW/Firmware/<br>Microprocesso<br>r Control | Microprocessor | Microprocessor | Microprocessor | Microprocessor | Same |
| Therapy Time | 20 minutes | User determines<br>therapy time. Choose<br>from 10, 20, or 30<br>minute session time,<br>with option to add<br>additional 10 minutes to<br>any therapy time. | 15 minutes | User controlled 10<br>minutes to 175<br>minutes or continuous<br>- total<br>time over 4<br>segments | Similar<br>Note 1 |
| Output<br>pressure range | 0~240 mmHg | 0~200 mmHg | 80 to 250 mmHg | 30-110 mmHg | Similar<br>Note 2 |
| Air pressure<br>level<br>/Compression<br>levels | 3 levels settings:<br>low level:150mmHg;<br>Mid level:185mmHg;<br>High Level: 215mmHg | Not publicly available | Not publicly available | Not publicly available | Not publicly available |
| Pressure error<br>range | $\pm$ 25mmHg | Not publicly available | Not publicly available | Unknown | Not publicly available |
| Inflation time | 3-30s | Not publicly available | Not publicly available | Not publicly available | Similar |
| Keep time | 1-5s | Not publicly available | Not publicly available | Not publicly available | Note 11 |
| Deflation time | 1-5s | Not publicly available | Not publicly available | Not publicly available | Same |
| Mode types | Sequential/ Peristaltic | Sequential/ Peristaltic | Sequential/ Peristaltic | Sequential/ Peristaltic | Same |
| Cycle time | Range of 25 sec to 3 | Not publicly available | Not publicly available | Not publicly available | Similar |
| Device | Subject device | Primary Predicate<br>device | Secondary Predicate<br>device | Third Predicate<br>device | Comparison |
| | min 40 sec | | | | Note 4 |
| Number of<br>chambers | 3 Chambers | 4 Chambers | 12 Chambers | 4 Chambers | Similar<br>Note 7 |
| Number of<br>treatment<br>mode | 3 modes | 2 modes | 1 mode | 2 modes | Similar<br>Note 6 |
| Modes (visual<br>description) | Mode 1:<br>Starting with the foot<br>chamber and<br>progressing up the thigh<br>chamber, each section<br>compresses and the<br>pressure gradually rises<br>to the pre-determined<br>air pressure level, then<br>decompresses and the<br>air pressure drops.<br>Once the thigh section<br>decompresses, the<br>cycle begins again.<br>Mode 1 follows this<br>pressure sequence:<br><br>Image: Mode 1 pressure sequence<br><br>Mode 2:<br>Starting with the foot<br>chamber and<br>progressing up the<br>thigh, each section | Mode A:<br>Starting with the distal<br>chamber and<br>progressing up the<br>proximal chamber, each<br>section compresses and<br>the pressure gradually<br>rises to the pre-<br>determined air pressure<br>level, then<br>decompresses and the<br>air pressure drops. Once<br>the top section<br>decompresses, the cycle<br>begins again.<br>Mode A follows this<br>pressure sequence:<br><br>Image: Mode A pressure sequence<br><br>Mode B:<br>Starting with the distal | Starting with the distal<br>chamber and<br>progressing up the<br>proximal chamber,<br>each section<br>compresses and the<br>pressure gradually<br>rises to the pre-<br>determined air<br>pressure level, then<br>decompresses and the<br>air pressure drops.<br>Operating until the top<br>section decompresses,<br>the cycle begins again.<br>Only has one mode. Follows<br>this sequence:<br><br>Image: Secondary Predicate device pressure sequence | Sequential mode:<br>Starting with the distal<br>chamber and<br>progressing up the<br>proximal chamber, each<br>section compresses<br>and the pressure<br>gradually rises to the<br>pre-determined air<br>pressure level, then<br>decompresses and the<br>air pressure drops.<br>Once the top section<br>decompresses, the<br>cycle begins again.<br>Again.<br>"Sequential:"<br><br>Image: Sequential mode pressure sequence<br><br>Normatec Pulse | Same |
| Device | Subject device | Primary Predicate device | Secondary Predicate device | Third Predicate device | Comparison |
| | compresses and the<br>pressure gradually rises<br>to the pre-determined<br>air pressure level, holds<br>the air until the entire<br>garment is compressed.<br>All three sections then<br>decompress<br>simultaneously and the<br>air pressure drops, then<br>cycle begins again.<br>Mode 2 follows this<br>pressure sequence:<br>Image: Mode 2 pressure sequence | chamber and<br>progressing up the<br>proximal chamber, each<br>section compresses and<br>the pressure gradually<br>rises to the pre-<br>determined air pressure<br>level, holds the air until<br>the entire boot is<br>compressed. All four<br>sections then<br>decompress<br>simultaneously and the<br>air pressure drops, then<br>cycle begins again.<br>Mode B follows this<br>pressure sequence:<br>Image: Mode B pressure sequence | | mode:<br>Starting with the distal<br>zone and progressing<br>up the proximal zone,<br>one zone compresses<br>and the pressure<br>gradually rises to the<br>pre-determined air<br>pressure level, holds<br>the air of previous<br>two zone , the other<br>zones do not hold, until<br>the last zone finished,<br>deflate the all last three<br>zone then enter into<br>next cycle.<br>"Pulse Massage Pattern:"<br>Image: Pulse Massage Pattern | |
| | Mode 3:<br>include two stage, stage<br>1: it work according to<br>the method of mode 1,<br>after the stage 1 is<br>completed, it go to<br>stage 2(working<br>according to the method<br>of mode 2) without<br>interruption time until<br>finish the stage 2, then<br>enter next cycle without<br>interruption .<br>Mode1 Mode2<br>The pressure sequence | | | | |
| Device | Subject device | Primary Predicate<br>device | Secondary Predicate<br>device | Third Predicate<br>device | Comparison |
| | of mode 3 combines<br>mode 1 and mode 2 | | | | |
| Noise level | ≤ 65dB | Not publicly available | Not publicly available | Not publicly available | Similar<br>Note 9 |
| Sleeve<br>Material | Nylon with a<br>Polyurethane laminate…