Air Compression Therapy System

K192466 · Shenzhen Lifotronic Technology Co., Ltd. · IRP · Jun 22, 2020 · Physical Medicine

Device Facts

• Record ID: K192466
• Device Name: Air Compression Therapy System
• Applicant: Shenzhen Lifotronic Technology Co., Ltd.
• Product Code: IRP · Physical Medicine
• Decision Date: Jun 22, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5650
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Airpro-690 is intended for use by medical professionals and patients at home, who are under medical supervision, in treating many conditions, such as Primary lymphedema, Edema following trauma and sport injuries, Post immobilization edema, Venous insufficiencies, Lymphedema.

Device Story

Airpro-690 is a pneumatic compression therapy system consisting of a main controller unit, air tubing, and inflatable sleeves. It is used by medical professionals or patients at home under supervision. The device operates by rhythmically inflating and deflating multi-chamber sleeves to apply sequential pressure to limbs. This action promotes venous blood return, enhances arterial infusion, and improves blood and lymphatic circulation. The controller features two independent or simultaneous channels and automatically identifies connected sleeve types. Users adjust treatment time, pressure, and mode via the parameter settings interface. The device benefits patients by managing edema and circulatory conditions through controlled pneumatic compression.

Clinical Evidence

Bench testing only. No clinical data provided. Verification and validation testing confirmed compliance with ISO 10993-1, ISO 10993-5, ISO 10993-10, ANSI/AAMI ES60601-1, and IEC 60601-1-2 standards.

Technological Characteristics

Pneumatic compression device; 4 or 8 chambers; sequential compression mode; pressure range 0-180 mmHg; AC 120V/60Hz power source; nylon sleeves (biocompatible per ISO 10993-5/10); desk-type form factor; 3.5 kg weight; software-controlled parameter settings.

Indications for Use

Indicated for adults with primary lymphedema, edema following trauma/sports injuries, post-immobilization edema, venous insufficiencies, and lymphedema.

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

• Compressible Limb Therapy System, Model LX7(V7) (K102320)

Submission Summary (Full Text)

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June 22, 2020

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

Re: K192466

Trade/Device Name: Air Compression Therapy System, Model: Airpro-690 Regulation Number: 21 CFR 890.5650 Regulation Name: Powered Inflatable Tube Massager Regulatory Class: Class II Product Code: IRP Dated: January 18, 2020 Received: January 22, 2020

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.

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

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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,

Amber Ballard, PhD Assistant Director (Acting) THT5B4: Neurodegenerative 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) K192466

Device Name

Air Compression Therapy System, Model: Airpro-690

Indications for Use (Describe)

Airpro-690 is intended for use by medical professionals and patients at home, who are under medical supervision, in treating many conditions, such as Primary lymphedema, Edema following trauma and sport injuries, Post immobilization edema, Venous insufficiencies, Lymphedema.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | <span> <span style="text-decoration: overline;">X</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> |

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# 510(K) Summary

#### 1. Submitter's Information

#### Establishment Reqistration Information

Name: Shenzhen Lifotronic Technology Co., Ltd. Address: Unit A, 4th Floor, Building 15, Yijing Estate, No.1008 Songbai Road, Nanshan District, Shenzhen City, Guangdong Province, 518055, P.R.China

#### Contact Person of applicant

Name: Xiang Lei Address: Unit A, 4th Floor, Building 15, Yijing Estate, No.1008 Songbai Road, Nanshan District, Shenzhen City, Guangdong Province, 518055, P.R.China TEL: [phone] FAX: [phone] Email: [e-mail]

#### Contact Person of the Submission:

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

Date to prepare: 8/13/2019

## 2. Device Information

Type of 510(K) submission: Traditional Trade Name: Air Compression Therapy System Model: Airpro-690 Common name: Compression Therapy Device Classification Name: massager, powered inflatable tube. Regulation Description: Powered inflatable tube massager. Review panel: Physical Medicine Product code: IRP Regulation Class: II Requlation Number: 21 CFR 890.5650

#### 3. Predicate Device Information

510(k) submitter/holder: DAESING MAREF CO LTD 510(K) Number: K102320 Device: Compressible Limb Therapy System Trade name: LX7(V7) Classification Name: massager, powered inflatable tube. Regulation Description: Powered inflatable tube massager.

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Review panel: Physical Medicine Product code: IRP Requlation Class: II Regulation Number: 21 CFR 890.5650

#### 4. Device description

Air Compression System include the host, sleeves, and the air tube to connect them together. Through a multi-chamber inflatable sleeve orderly conducting of rhythmic squeezing inflation and deflation, it cyclic pressure on limb tissue, so as to promote venous blood return, enhance arterial infusion, improve blood circulation and lymphatic circulation. Two port on the back of the controller, labeling as Channel 1/2. And four air ways on each channel. The two channels can work independently, or simultaneously. The system can identify the channel and type of wearing sleeves automatically. If two channels were connected with sleeves, the system will inflate 1/2 channel simultaneously. Treatment Time, pressure, Channel and Treatment Mode are all can be adjusted on Parameter Settings Interface of the main unit.

## 5. Principle of operation:

The Air Compression Therapy System, model Airpro-690 is a pneumatic compression device and designed to apply pneumatic compression to limbs to treat conditions. It works by inflating and deflating the sleeve sequentially to develop the circulating pressure on the limbs and organization. Squeezing the proximal and distal of the limbs to promote the flow of the blood and lymphatic system, and improve the microcirculation. The System consists of the main unit, the Tubing Sets and sleeves.

#### 6. Indications for Use

Airpro-690 is intended for use by medical professionals and patients at home, who are under medical supervision, in treating many conditions, such as Primary lymphedema, Edema following trauma and sport injuries, Post immobilization edema, Venous insufficiencies, Lymphedema.

# 7. Summary of technological characteristics of device compared to the predicate devices (K102320)

| Characteristic | Subject device<br>Present application<br>(Air Compression<br>Therapy System, model<br>Airpro-690) | Predicate device<br>(K102320, Compressible<br>Limb Therapy System,<br>Model LX7(V7)) | Discussion of difference |
|-------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification | 21 CFR 890.5650 | 21 CFR 890.5650 | Same |
| Product Code | IRP | IRP | Same |
| FDA Class | 2 | 2 | Same |
| Intended Use | Airpro-690 is intended for<br>use by medical<br>professionals and patients<br>at home, who are under<br>medical supervision, in<br>treating many conditions,<br>such as Primary<br>lymphedema, Edema<br>following trauma and sport<br>injuries, Post<br>immobilization edema. | LX7(V7) is intended for<br>use by medical<br>professionals and patients<br>at home, who are under<br>medical supervision, in<br>treating many conditions,<br>such as Primary<br>lymphedema, Edema<br>following trauma and sport<br>injuries, Post<br>immobilization edema. | Same |
| | Venous insufficiencies,<br>Lymphedema. | Venous insufficiencies,<br>Lymphedema. | |
| Principle of operation | intermittent pneumatic<br>compression device | intermittent pneumatic<br>compression device | Same |
| target population | adults | adults | Same |
| anatomical site | Leg | Leg | Same |
| Material of Patient contact<br>components | Sleeve:<br>Nylon | Sleeve:<br>Nylon | Same<br>Sleeve was demonstrated<br>biocompability safety by<br>passing ISO 10993-5 and<br>ISO 10993-10 tests. The<br>difference does not raise<br>the issue of product's safety<br>and effectiveness. |
| where used | home | home | Same |
| Design | Desk type | Desk type | Same |
| Power Source | a.c. 120V, 60Hz | Electricity Supply: 230<br>V~,50/60 Hz<br>Electricity consumption:<br>50 VA | Similar<br>The proposed device was<br>demonstrated electrical<br>safety by passing ANSI/<br>AAMI ES60601-1: 2005+<br>A1: 2012 test. The<br>difference in power source<br>does not raise any question<br>in regards to safety and<br>effectiveness. |
| ANSI AAMI ES60601-1 | Yes | Yes | Same |
| IEC 60601-1-2 | Yes | Yes | Same |
| Weight | 3.5 Kg | 2Kg(main system only) | Different<br>The Weight will not affect<br>the safety and effectiveness<br>of the proposed device |
| Dimensions<br>(W x H x D) | 235mm(L)x185mm(W)×<br>190mm(H) | 260(W) * 160(D) *<br>120(H)mm | Different<br>The dimensions will not<br>affect the safety and<br>effectiveness of the<br>proposed device |
| Number of Chamber | 4chambers, 8chambers | 4chambers, 8chambers | Same |
| Related power | 55VA | 50VA | Similar<br>The proposed device was<br>demonstrated electrical<br>safety by passing ANSI/<br>AAMI ES60601-1: 2005+<br>A1: 2012 test. The<br>difference in power does<br>not raise any question in<br>regards to safety and<br>effectiveness. |
| Mode of Compression | Sequential | Sequential | Same |
| Mode description | 3 modes | 3 modes | Same |
| Pressure range | 0~180mmHg | 0~230mmHg (Air pump<br>pressure range) | Similar<br>The pressure range for<br>proposed device is smaller |
| | | 60~120mmHg<br>(Recommended operating<br>pressure range)<br>(unit of pressure<br>increment : 20mmHg) | Additional risks not<br>concerns for safety and<br>effectiveness. |
| Operating Time/Therapy<br>Time | 10, 20, 30minutes | 10~30minutes | Similar |
| Compression Cycle Time | 30min | 30min | Same |

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

Non-clinical verification testing of the Air Compression Therapy System, model: Airpro-690 included electrical, mechanical, and software tests to show the device meets its design specifications. Validation and performance testing validates that the device meets its user needs. Verification and validation test results established that the device meets its intended use, that it is as safe, as effective, and performs as well as the predicate devices, and that no new issues of safety and effectiveness were raised. The Air Compression Therapy System, model: Airpro-690 was designed, verified, and validated according to the company's Design Control process and has been subjected to extensive safety and performance testing as shown in the test results provided in this submission. Verification and Validation testing data demonstrate that the device meets all of its specifications including compliance with the following standards:

ISO 10993-1: 2009-10-15 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process [Including: Technical Corrigendum 1 (2010)]

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. Tests for irritation and skin sensitization

ANSI AAMI ES60601-1:2005/(R) 2012 and A1:2012 Medical electrical equipment. General requirements for basic safety and essential performance

IEC 60601-1-2:2014 Medical electrical equipment - part 1-2: general requirements for safety collateral standard: electromagnetic compatibility - requirements and tests

# 9. Conclusions

The electrical safety. EMC. biocompatibility, software verification, and validation, basic unit characteristics, and output specifications information provided is sufficient to demonstrate substantial equivalence to the predicate device. As the Air Compression Therapy System, model: Airpro-690 is nearly identical to the predicate device, differences in their characteristics do not raise any raise new questions regarding safety and effectiveness with identical indications for use and essentially identical technological characteristics, the Air Compression Therapy System, model: Airpro-690 is substantially equivalent to the predicate device Compressible Limb Therapy System, Model LX7(V7).