Air Compression Therapy Recovery System (model: MF-AWI, MF-AWI.LED.A-801, MF-AWI.LED.B-801, MF-AWI.OLED.A-601, MF-AWI.LED.A-601, MF-AWI.LED.B-601, MF-AWI.OLED.A-401, MF-AWI.LED.A-401, MF-AWI.LED.B-401)
Device Facts
| Record ID | K230500 |
|---|---|
| Device Name | Air Compression Therapy Recovery System (model: MF-AWI, MF-AWI.LED.A-801, MF-AWI.LED.B-801, MF-AWI.OLED.A-601, MF-AWI.LED.A-601, MF-AWI.LED.B-601, MF-AWI.OLED.A-401, MF-AWI.LED.A-401, MF-AWI.LED.B-401) |
| Applicant | Jiangsu Maxf Electric Appliance Co., Ltd. |
| Product Code | IRP · Physical Medicine |
| Decision Date | Oct 26, 2023 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 890.5650 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Intended Use
The Air Compression Therapy Recovery System (model: MF-AWI.LED.A-801, MF-AWI.LED.B-801, MF-AWI.OLED.A-601, MF-AWI.LED.A-601, MF-AWI.LED.B-601, MF-AWI.OLED.A-401, MF-AWI.LED.A-401, MF-AWI.LED.B-401) is indicated for the temporary relief of minor muscle aches and pains and for temporary increase in circulation to the treated areas. The Air Compression Therapy Recovery System simulates kneading and stroking of tissues by using an inflatable garment. This device is Over-The-Counter (OTC). It is intended for use by healthy adults who are over 21 years old.
Device Story
Portable pneumatic compression system; uses electronically controlled air pump and valves to inflate garment chambers (boots, sleeves, pants). Simulates kneading/stroking of tissues to increase circulation and relieve muscle aches. Operated by user in home, clinic, or athlete training environments. Control unit houses pump/valves; microprocessor manages inflation/deflation cycles based on selected mode and pressure. User selects therapy time and pressure; device provides sequential compression. Benefits include temporary muscle pain relief and improved circulation. Healthcare providers/users monitor therapy via control unit interface; device includes manual stop/pause button for safety.
Clinical Evidence
No clinical data. Bench testing only. Performance verified via electrical safety (IEC 60601-1), EMC (IEC 60601-1-2), home healthcare environment standards (IEC 60601-1-11), and biocompatibility (ISO 10993-5, -10, -23).
Technological Characteristics
Control unit with ABS plastic enclosure; TPU Nylon Composite garments. Pneumatic system with air pump/valves. 4, 6, or 8 chambers. Pressure range 0-200 mmHg. Power 100-240V, 50/60Hz. Microprocessor-controlled. Software level of concern: Moderate. No external interfaces/cybersecurity requirements.
Indications for Use
Indicated for healthy adults over 21 years old for temporary relief of minor muscle aches and pains and temporary increase in circulation to treated areas (leg, arm, hip).
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
Related Devices
- K201645 — Massage Compression Boots · Jkh USA, LLC · Sep 15, 2020
- K233536 — Air Compression Recovery System · Shenzhen Dongjilian Medical Tech Co., Ltd. · Dec 16, 2023
- K202044 — Powerpress Recovery Unit · Hanuri Distribution, Inc. · Oct 21, 2020
- K182668 — Rapid Reboot Compression Therapy System · Rapid Reboot Recovery Products, LLC · Dec 14, 2018
- K192358 — Pressure Therapy System PT1003 · Xiamen Senyang Co., Ltd. · Apr 23, 2020
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). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square and the words "U.S. FOOD & DRUG ADMINISTRATION".
October 26, 2023
Jiangsu MaxF Electric Appliance Co., Ltd % Cassie Lee Official Correspondent Share Info (Guangzhou) Medical Consultant Ltd No. 1919-1920, Building D3, Minjie Plaza Shuixi Road, Huangpu District Guangzhou, Guangdong 510000 China
Re: K230500
Trade/Device Name: Air Compression Therapy Recovery System (model: MF-AWI.LED.A-801, MF-AWI.LED.B-801, MF-AWI.OLED.A-601, MF-AWI.LED.A-601, MF-AWI.LED.B-601, MF-AWI.OLED.A-401, MF-AWI.LED.A-401, MF-AWI.LED.B-401) Regulation Number: 21 CFR 890.5650 Regulation Name: Powered Inflatable Tube Massager Regulatory Class: Class II Product Code: IRP Dated: August 10, 2023 Received: August 11, 2023
# Dear Cassie Lee:
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
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Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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 (QS) 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.
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 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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Heather L. Dean -S
Heather Dean, PhD
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Assistant Director, Acute Injury Devices Team DHT5B: Division of Neuromodulation and Rehabilitation 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) K230500
#### Device Name
Air Compression Therapy Recovery System (model: MF-AWI.LED.A-801. MF-AWI.LED.B-801. MF-AWI.OLED.A-601. MF-AWI.LED.A-601, MF-AWI.LED.B-601, MF-AWI.OLED.A-401, MF-AWI.LED.A-401, MF-AWI.LED.B-401)
#### Indications for Use (Describe)
The Air Compression Therapy Recovery System (model: MF-AWI.LED.A-801, MF-AWI.LED.B-801, MF-AWI.OLED.A-601, MF-AWI.LED.A-601, MF-AWI.LED.B-601, MF-AWI.OLED.A-401, MF-AWI.LED.A-401, MF-A WI.LED.B-401) is indicated for the temporary relief of minor muscle aches and pains and for temporary increase in circulation to the treated areas. The Air Compression Therapy Recovery System simulates kneading of tissues by using an inflatable garment. This device is Over-The-Counter (OTC). It is intended for use by healthy adults who are over 21 years old.
| Type of Use (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 K230500
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirement of 21 CFR 807.92.
#### 1. Submitter's Information
Name: Jiangsu MaxF Electric Appliance Co., Ltd Establishment Registration Number: 3017153262 Address: NO.12, West Park Road, Rulin Town, Jintan District, Changzhou, China
Contact name: ZHANG JIANFANG Tel: +86-15961228139 E-mail: 372601574@qq.com Postal Code: 213200
#### Application Correspondent:
Name: Share Info (Guangzhou) Medical Consultant Ltd. Contact Person: Ms. Cassie Lee Address: No. 1919-1920, Building D3, Minjie Plaza, Shuixi Road, Huangpu District, Guangzhou, China Tel: +86 20 8266 2446 Email: regulatory@share-info.com
# 2. Date of the summary prepared: October 25, 2023
#### 3. Subject Device Information
Classification Name: Massager, powered inflatable tube Trade Name: Air Compression Therapy Recovery System Model Name: MF-AWI, MF-AWI.LED.A-801, MF-AWI.LED.B-801, MF-AWI.OLED.A-601, MF-AWI.LED.A-601, MF-AWI.LED.B-601, MF-AWI.OLED.A-401, MF-AWI.LED.A-401, MF-AWI.LED.B-401 Review Panel: Physical Medicine Product Code: IRP Regulation Number: 890.5650 Regulatory Class: II
# 4. Predicate Device Information
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# Predicate Device 1 Information
Sponsor: Rapid Reboot Recovery Products, LLC Trade Name: Rapid Reboot Compression Therapy System Classification Name: Massager, powered inflatable tube 510(K) Number: K182668 Review Panel: Physical Medicine Product Code: IRP Regulation Number: 890.5650 Regulation Class: II
#### Predicate Device 2 Information
Sponsor: FOSHAN HONGFENG CO.,LTD. Trade Name: Air compression therapy system Classification Name: Massager, powered inflatable tube 510(K) Number: K201982 Review Panel: Physical Medicine Product Code: IRP Regulation Number: 890.5650 Regulation Class: II
#### 5. Device Description
The Air Compression Therapy Recovery System (model: MF-AWI.LED.A-801, MF-AWI.LED.B-801, MF-AWI.OLED.A-601, MF-AWI.LED.A-601, MF-AWI.LED.B-601, MF-AWI.OLED.A-401, MF-AWI.LED.A-401, MF-AWI.LED.B-401) is a portable inflatable tube massage system which simulates kneading and stroking of leg, arm and hip by the use of inflatable air compression techniques. The device can be used to temporarily increase blood circulation and temporarily relieve minor muscle aches and pains. This device is Over-The-Counter (OTC). It is intended for use by healthy adults who are over 21 years old.
The device utilizes the pneumatically controlled chambers actuated by an electronically controlled air pump and air valve. The pump, air valve and other components are protectively housed within the ABS plastic enclosure of the control unit.
The device consists of a control unit, two RecoveryLeg (air boot with attached hose connector), two RecoveryArm (air arm sleeve with attached hose connector) and one RecoveryPants (air pants with two attached hoses and hose connectors). The RecoveryLeg, RecoveryArm and RecoveryPants 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 boots, sleeves or pants to compress body.
The device is categorized to have long-term skin contact of greater than 30 days.
Environment of use of the device: Clinics, hospital, athlete training, and home environments.
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# 6. Intended Use / Indications for Use
The Air Compression Therapy Recovery System (model: MF-AWI.LED.A-801, MF-AWI.LED.B-801, MF-AWI.OLED.A-601, MF-AWI.LED.A-601, MF-AWI.LED.B-601, MF-AWI.OLED.A-401, MF-AWI.LED.A-401, MF-AWI.LED.B-401) is indicated for the temporary relief of minor muscle aches and pains and for temporary increase in circulation to the treated areas. The Air Compression Therapy Recovery System simulates kneading and stroking of tissues by using an inflatable garment. This device is Over-The-Counter (OTC). It is intended for use by healthy adults who are over 21 years old.
#### 7. Comparison to predicate device and conclusion
As compared to the 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.
| Elements of<br>Comparison | Subject Device | Predicate Device<br>(Primary) | Predicate Device<br>(Secondary) | Remark |
|-----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------|-------------------|
| Company | Jiangsu MaxF Electric<br>Appliance Co., Ltd | Rapid Reboot<br>Recovery<br>Products, LLC | FOSHAN HONGFENG<br>CO.,LTD. | -- |
| Trade Name | Air Compression Therapy<br>Recovery System (model:<br>MF-AWI, MF-AWI.LED.A-<br>801,<br>MF-AWI.LED.B-801,<br>MF-AWI.OLED.A-601,MF-<br>AWI.LED.A-601,MF-<br>AWI.LED.B-601, MF-<br>AWI.OLED.A-401,MF-<br>AWI.LED.A-401,MF-<br>AWI.LED.B-401) | Rapid Reboot<br>Compression<br>Therapy System | Air compression<br>therapy system: FO-<br>3001 | -- |
| Classification<br>Name | Massager, Powered<br>inflatable tube | Massager, powered<br>inflatable tube | Massager, powered<br>inflatable tube | Same |
| 510(k)<br>Number | K230500 | K182668 | K201982 | -- |
| Product Code | IRP | IRP | IRP | -- |
| Regulation<br>Number | 890.5650 | 890.5650 | 890.5650 | Same |
| FDA Device<br>Classification | II | II | II | Same |
| Review Panel | Physical Medicine | Physical Medicine | Physical Medicine | Same |
| Rx or OTC | OTC | OTC | OTC | Same |
| Intended Use /<br>Indications for | The Air Compression<br>Therapy Recovery | The Rapid Reboot<br>Compression | Intended for home to<br>temporarily relieve | Same |
| Elements of<br>Comparison | Subject Device | Predicate Device<br>(Primary) | Predicate Device<br>(Secondary) | Remark |
| Use | System (model: MF-AWI,<br>MF-AWI.LED.A-801, MF-<br>AWI.LED.B-801, MF-<br>AWI.OLED.A-601, MF-<br>AWI.LED.A-601, MF-<br>AWI.LED.B-601, MF-<br>AWI.OLED.A-401, MF-<br>AWI.LED.A-401, MF-<br>AWI.LED.B-401) is<br>indicated for the<br>temporary relief of minor<br>muscle aches and pains<br>and for temporary<br>increase in circulation to<br>the treated areas. The Air<br>Compression Therapy<br>Recovery System<br>simulates kneading and<br>stroking of tissues by<br>using an inflatable<br>garment. This device is<br>Over-The-Counter (OTC).<br>It is intended for use by<br>healthy adults who are<br>over 21 years old. | Therapy System is<br>intended for the<br>temporary relief of<br>minor muscle<br>aches and pains<br>and for the<br>temporary increase<br>in circulation to the<br>treated areas in<br>people who are in<br>good health. The<br>Rapid Reboot<br>Compression<br>Therapy System<br>simulates kneading<br>and stroking of<br>tissues by using an<br>inflatable garment. | minor muscle aches<br>and/or pains, promote<br>blood circulation in<br>treated areas. | |
| Treatment<br>time | 0-50mins | User determines<br>therapy time.<br>Choose from 10,<br>20, or 30 minute<br>session time, with<br>option to add<br>additional 10<br>minutes to any<br>therapy time. | 1-60mins | Similar<br>Note 1 |
| Treatment<br>area | Leg (including of foot, calf,<br>knee, upper leg)<br>Hip (including of upper<br>leg, glutes, hips, lower<br>back)<br>Arm (including of entire<br>arm, shoulder, upper<br>chest and back) | Leg (including of<br>foot, calf, knee,<br>upper leg)<br>Hip (including of<br>upper leg, glutes,<br>hips, lower back)<br>Arm (including of<br>entire arm,<br>shoulder, upper<br>chest and back) | Leg | Same |
| Environment | Clinics, hospital, athlete | Clinics, hospital, | Not provided in the | Same |
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| Elements of<br>Comparison | Subject Device | Predicate Device<br>(Primary) | Predicate Device<br>(Secondary) | Remark |
|---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|
| | chambers one and two<br>are fully inflated, the third<br>and the fourth chamber<br>begin to inflate while the<br>first and the second<br>chambers begin to<br>deflate. The cycle repeats<br>through the 8 chambers.<br>Image: chambers | | for chamber ③④ till<br>chamber ⑤⑥, pause<br>for 3 seconds. Then<br>repeat. D (Whole<br>Squeeze Mode):<br>chamber ①②③④⑤⑥<br>inflating at the same<br>time till setup pressure<br>or for 90 seconds, then<br>deflating in the same<br>time for 3 seconds.<br>Then repeat. E<br>(Combined B + C):<br>sequential squeeze +<br>double wave F<br>(Combined A + C + D):<br>normal + double wave<br>+ whole squeeze. 4<br>and 8 chambers same<br>as 6 chambers above. | |
| | Mode D: Pressure fills<br>two chambers at a time<br>until all 8 are filled. The<br>first and the second<br>chambers inflate to the<br>selected pressure. Once<br>fully inflated, the third and<br>the fourth chambers begin<br>to inflate until all 8<br>chambers are fully<br>inflated. Then, all the 8<br>chambers deflate together<br>and the cycle repeats.<br>Image: chambers | | Image: chambers | |
| | Mode E: Pressure fills<br>one chamber at a time<br>and that chamber<br>deflates while next<br>chamber fills. When the<br>first chamber inflates to<br>the selected pressure, the<br>third chamber begins to<br>inflate and the first<br>chamber deflates. When<br>the third chamber fully<br>inflates, the fifth chamber<br>begins to inflate and the<br>third chamber deflates.<br>Then the seventh,<br>second, fourth, sixth and<br>eighth inflate and deflate<br>one by one | | | |
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| Elements of<br>Comparison | Subject Device | Predicate Device<br>(Primary) | Predicate Device<br>(Secondary) | Remark |
|--------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------|--------------------------------------------------------------|-------------------|
| | Image: [Subject Device Image]<br>For MF-AWI.OLED.A-601<br>and MF-AWI.OLED.A-401<br>using 6 chambers and 4<br>chambers, the mode is<br>the same as mode of MF-<br>AWI as demonstrated<br>above.<br>For<br>MF-AWI.LED.B-801,MF-<br>AWI.OLED.A-601,MF-<br>AWI.LED.A-601,MF-<br>AWI.LED.B-601, MF-<br>AWI.LED.A-401,MF-<br>AWI.LED.B-401<br>They only has one mode<br>(mode B). | | | |
| Output<br>pressure<br>range | 0-40-80-120-160-<br>200mmHg<br>(Tolerance: -10% ~<br>+20%) | 0-200 mmHg | 30-110mmHg | Similar<br>Note 1 |
| Power source | 100-240V, 50/60Hz | 110VAC, 60Hz | 100-127V/220-240V,<br>50/60Hz | Similar<br>Note 3 |
| Power | 30W | 30W | 65 W | Same |
| Number of<br>Chamber | 4, 6, 8 | 4 | 4, 6, 8 | Same |
| Photo/size of<br>the control<br>unit | Image: [Subject Device Photo] | Image: [Predicate Device (Primary) Photo]<br>10" x 6.5" x 5" | Image: [Predicate Device (Secondary) Photo]<br>220*190*113mm | Similar<br>Note 4 |
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| Elements of<br>Comparison | Subject Device | Predicate Device<br>(Primary) | Predicate Device<br>(Secondary) | Remark |
|------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|-------------------|
| | Image: Subject Device Top<br>Image: Subject Device Bottom<br>140mm x 87mm x 280mm | | | |
| Housing<br>materials | Molded ABS enclosure | Molded ABS enclosure | Molded ABS enclosure | Same |
| Compression<br>Applicator<br>Garments<br>Boots/Sleeves<br>/pants<br>Material | TPU Nylon Composite | Nylon with a<br>Polyurethane<br>laminate | Not mentioned in the<br>510k summary | Similar<br>Note 5 |
| Photo/size of<br>the boots | Image: Subject Device Boots<br>1060mm x 345mm | Image: Predicate Device Primary Boots<br>X-Short: 14" x 41"<br>Short: 14" x 43"<br>Medium: 14" x 45"<br>Long: 14" x 48"<br>X-Long: 14" x 52"<br>Image: Predicate Device Primary Boot Size | Image: Predicate Device Secondary Boots<br>M:91*65cm<br>L:100*74cm<br>XL:110*70cm<br>(Overlapping) | Similar<br>Note 4 |
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| Elements of<br>Comparison | Subject Device | Predicate Device<br>(Primary) | Predicate Device<br>(Secondary) | Remark |
|---------------------------------------------------|-------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------|-------------------|
| Photo/size of<br>the arm<br>sleeves | Image: Subject Device arm sleeves<br>974mm x 325mm | Image: Predicate Device (Primary) arm sleeves<br>Regular: 18" x 38"<br>Long: 18" x 44" | No arm sleeves | Similar<br>Note 4 |
| Photo/size of<br>the pants | Image: Subject Device pants<br>530mm x 730mm | Image: Predicate Device (Primary) pants<br>Regular:<br>26" x 32"<br>Large: 26"<br>35" | No pants | Similar<br>Note 4 |
| Safety feature | Button on control unit<br>allow users to stop or<br>pause therapy session at<br>any time. | Button on display<br>allows users to stop<br>or pause therapy<br>session at any time. | Power button on main<br>unit allows user to stop<br>therapy session at any<br>time | Same |
| Mode of<br>compression | Sequential | Sequential | Sequential | Same |
| Software/firm<br>ware/micropro<br>cess or control | Microprocessor | Microprocessor | Microprocessor | Same |
| Technology | Compressor and valve<br>system which sequentially<br>inflates cells of appliance. | Compressor and<br>valve<br>system which<br>sequentially<br>inflates cells of<br>appliance. | Compressor and valve<br>system which<br>sequentially inflates<br>inflatable chambers | Same |
| Electrical | ANSI-AAMI ES 60601-1 | ANSI-AAMI ES | IEC 60601-1 | Same |
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| Elements of<br>Comparison | Subject Device | Predicate Device<br>(Primary) | Predicate Device<br>(Secondary) | Remark |
|---------------------------------------|----------------|-------------------------------|---------------------------------|--------|
| safety, EMC,<br>Bio-<br>compatibility | IEC 60601-1-2 | 60601-1 | IEC 60601-1-2 | |
| | IEC 60601-1-11 | IEC 60601-1-2 | IEC 60601-1-11 | |
| | ISO 10993-5 | IEC 60601-1-11 | ISO 10993-10 | |
| | ISO 10993-10 | ISO 10993-5 | ISO 10993-5 | |
| | ISO 10993-23 | ISO 10993-10 | ISO 10993-12 | |
#### Comparison in Detail(s):
#### Note 1:
Though there is a little difference of "treatment time" and "output pressure range" between the subject device and predicate devices, but treatment time is within the time range of predicate device 2, and output pressure range is within the predicate device 1. So, this slight difference will not raise any safety and effectiveness issue.
# Note 2:
The mode A, B, C of subject device is similar to the Normal Mode, Sequential Squeeze Mode and Double Wave mode of predicate device 1 respectively. The inflating and deflating order of mode D, and E is different from predicate devices, but will not raise any safety and effectiveness issue.
#### Note 3:
Though there is difference of "power source" between the subject device and predicate device, but the subject device has been tested per ANSI/AAMI ES60601-1, IEC 60601-1-11. So, the difference of modes would not adversely impact safety and effectiveness.
#### Note 4:
Though there is difference of "Photo/size of the control unit", "Photo/size of the boots", "Photo/size of the arm sleeves", "Photo/size of the pants sleeves" between subject device and predicate devices 1, but the difference would not adversely impact safety and effectiveness.
#### Note 5:
Though there is difference in material of boots/sleeves/pants does not contact with skin during the massage, and the TPU Nylon Composite has been tested per ISO 10993-10 and ISO 10993-23, so the difference would not adversely impact safety and effectiveness.
#### 8. Test Summary
#### 8.1 Summary of Non-Clinical Performance Testing
#### 1) Performance Testing Summary
The Air Compression Therapy Recovery System (model: MF-AWI.LED.A-801, MF-AWI.LED.B-801, MF-AWI.OLED.A-601, MF-AWI.LED.A-601, MF-AWI.LED.B-601, MF-AWI.OLED.A-401, MF-AWI.LED.A-401, MF-AWI.LED.B-401) has been evaluated the safety and performance by lab bench testing as following:
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| Title of the test | Device<br>Description<br>/Sample<br>Size | Test<br>Method/Ap<br>plicable<br>Standards | Acceptance<br>criteria | Unexpec<br>ted<br>Results/<br>Significa<br>nt<br>Deviatio<br>ns | Test<br>results |
|--------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------|--------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------|-----------------|
| General<br>requirements for<br>basic safety and<br>essential<br>performance | The test<br>sample is<br>the final,<br>finished<br>product. | IEC 60601-<br>1:2005/AMD<br>1:2012/AMD<br>2:2020 | The test is<br>carried out<br>under the test<br>method<br>specified in the<br>standard, and<br>the test result is<br>within the test<br>acceptance<br>range of the<br>standard. | NA | Pass |
| Electromagnetic<br>disturbances | The<br>test<br>sample<br>is<br>the<br>final,<br>finished<br>product. | IEC 60601-<br>1-<br>2:2014+A1:<br>2020 | No degradation<br>of performance<br>was<br>found<br>during<br>test or<br>Lower<br>than<br>limits<br>of<br>measurement | NA | Pass |
| Requirements<br>for medical<br>electrical<br>equipment and<br>medical<br>electrical<br>systems used in<br>the home<br>healthcare<br>environment. | The<br>test<br>sample<br>is<br>the<br>final,<br>finished<br>product. | IEC 60601-<br>1-<br>11:2015/AM<br>D1:2020 | The<br>device<br>operates<br>normally, and<br>can<br>provide<br>basic<br>safety<br>and<br>essential<br>performance. | NA | Pass |
#### Biocompatibility testing 2)
- . ISO 10993-1: 2018 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management.
- . ISO 10993-5:2009 Biological Evaluation of Medical Devices - Part 5: Tests For In Vitro Cytotoxicity
- . ISO 10993-10:2021Biological Evaluation of Medical Devices - Part 10: Tests skin sensitization
- . ISO 10993-23: 2021 Biological Evaluation of Medical Devices - Part 23: Test for irritation
# 3) Software verification and validation testing
Software verification and validation testing were conducted and documentation was provided as recommended by FDA'S Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as
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a "moderate" level concern, since a malfunction of, or a latent design flaw in, the Software Device leads to an erroneous diagnosis or a delay in delivery of appropriate medical care that would likely lead to Minor Injury.
# 4) Cybersecurity
The subject device no any external interfaces, according to FDA guidance "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices", no need cybersecurity evaluation.
# 8.2 Clinical Performance
Clinical testing was not needed for this 510(k). The non-clinical performance testing described above is sufficient to support that the device can be used safely and effectively.
#### 9. Final Conclusion:
The subject device is as safe, as effective, and performs as well as or better than the legally marketed predicate devices K182668 and K201982.
