Air Relax Pro Model AR-4.0

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September 2, 2021 Diode Art Engineering doing business as Air Relax % Prithul Bom Most Responsible Person Regulatory Technology Services, LLC 1000 Westgate Drive, Suite 510k Saint Paul, Minnesota 55114 Re: K212491 Trade/Device Name: Air Relax Pro Model AR-4.0 Regulation Number: 21 CFR 890.5650 Regulation Name: Powered inflatable tube massager Regulatory Class: Class II Product Code: IRP Dated: August 7, 2021 Received: August 9, 2021 Dear Prithul Bom: 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/cdrl/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. {1}------------------------------------------------ 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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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 {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) ### K212491 Device Name ### Air Relax Pro Model AR-4.0 Indications for Use (Describe) The Air Relax Pro Model AR-4.0 is intended for the temporary relief of minor muscle aches and for temporary increase in circulation to the treated areas in people who are in good health. The Air Relax Pro Model AR-4.0 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) ### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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FORM FDA 3881 (6/20) PE PSC Publishing Services (301) 443-6740 {3}------------------------------------------------ #### 510(k) Summary K212491 | Date Prepared: | July 23, 2021 | |----------------------------|-----------------------------------------------------------------------------------------------------------------------| | Applicant | Diode Art Engineering doing business as Air Relax<br>9535 Brasher St<br>Pico Rivera, CA 90660<br>Tel - 1.323.285.4231 | | Official Contact: | Beomjoon Lee, General Manager | | Proprietary or Trade Name: | Air Relax Pro Model AR-4.0 | | Common/Usual Name: | Powered Inflatable Tube Massager | | Classification Name: | IRP - Massager Powered Inflatable Tube (CFR 890.5650) | | Predicate Devices: | K211460 - Air Relax Model AR-3.0 | ### Device Description: This submission is for the Diode Art Engineering Air Relax Pro Model AR-4.0. The Air Relax Pro Model AR-4.0 is a powered inflatable tube massager. It is intended to temporarily relieve minor muscle aches and pains, and to temporarily increase circulation to the treated areas. It simulates manual kneading and stroking of tissues by use of an inflatable pressure cuff. The device is to be used by people who are in good health. The device is a Class II, type BF applied part that receives power a separately approved external IEC 60601-1 compliant power supply or optional battery pack. The Air Relax Pro Model AR-4.0 consists of an air compressor unit with a control system, an inflatable "garment" (arms, legs and hips), plastic air tubing with a proprietary connector for connecting the device to the garment. A description of each of these components is provided below. The hip garment is also referred to as "shorts". The user interface is a front panel display and buttons. The Air Relax Pro Model AR-4.0 contains an air compressor with a system control that that allows the user to adjust the amount of air coming from the air compressor and going to the individual segments of the inflatable garment. There is no electrical contact with the user and the device does not transfer or detect energy to or from the user. The user interface of the Air Relax Pro Model AR-4.0 provides for starting and stopping the massage treatment, allows for adjusting time and intensity (pressure) of the treatment. The device also provide a proprietary keyed connector to the tubing {4}------------------------------------------------ #### 510(k) Summary Page 2 of 7 which connects to the garment. The tubing connector at the garment is also proprietary. The proprietary connectors ensure that neither the device, tubing nor garment can be misconnected to any other device or garment. Pressure selection is performed by pressing pressure button multiple times. Pressure level is selectable between 40 and 170 mmHg There are four modes (Progressive, Sequential, Drain and Overlay) that determine the inflation sequence of the cells within the garments.. ## Intended Use / Indications for Use: The Air Relax Pro Model AR-4.0 is intended 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 Relax Pro simulates kneading and stroking of tissues by using an inflatable garment. Patient Population: Adults ## Environments of Use: Clinics, hospital, athlete training, and home environments {5}------------------------------------------------ ## 510(k) Summary Page 3 of 7 | Model Name<br>510(k)<br>Number | Subject Device<br>Air Relax Pro<br>Model AR-4.0<br>K212491 | Predicate Device<br>Air Relax Plus<br>Model AR-3.0<br>K211460 | Comment | |------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------| | Classification | Class II Device, IRP<br>(21 CFR890.5650) | Class II Device, IRP<br>(21 CFR890.5650) | Identical | | Indications<br>for use | The Air Relax Pro Model<br>AR-4.0 is intended 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 in people<br>who are in good health.<br>The Air Relax Pro Model<br>AR-4.0 simulates<br>kneading and stroking of<br>tissues by using an<br>inflatable garment | The Air Relax Plus Model<br>AR-3.0 is intended for the<br>temporary relief of minor<br>muscle aches and pains and<br>for the temporary increase<br>in circulation to the treated<br>areas in people who are in<br>good health. The Air Relax<br>Plus Model AR-3.0<br>simulates kneading and<br>stroking of tissues by using<br>an inflatable garment | Identical | | OTC or<br>Prescription | OTC | OTC | Identical | | Environment<br>of Use | Clinics, hospital, athlete<br>training, and home<br>environments | Clinics, hospital, athlete<br>training, and home<br>environments | Identical | | Compliance<br>with<br>standards | ES 60601-1, IEC 60601-<br>1-2, IEC 60601-1-11 | ES 60601-1, IEC 60601-<br>1-2, IEC 60601-1-11 | Identical | | Mode of<br>Operation | Sequential/Peristaltic | Sequential/Peristaltic | Identical | | Power | 100~240V, 50/60Hz | 100~240V, 50/60Hz | Identical | | Device<br>Pressure<br>range | 40 - 170 mmHg | 60 - 170 mmHg | Similar to<br>predicate except<br>low pressure, it<br>does not affect<br>safety and<br>effectiveness. | | Garments<br>material | Nylon with a<br>Polyurethane<br>Laminate | Nylon with a<br>Polyurethane<br>Laminate | Identical | | Leg<br>Attachment | Yes<br>Size "2" : 34 X 15.35<br>Size "3" : 38.2 X 15.35<br>Size "4" : 42 X 15.35 | Yes<br>Size "2" : 34 X 15.35<br>Size "3" : 38.2 X 15.35<br>Size "4" : 42 X 15.35 | Identical in size<br>and materials.<br>Number of<br>Inflatable garment<br>segments differs. | | Model Name<br>510(k)<br>Number | Subject Device<br>Air Relax Pro<br>Model AR-4.0<br>K212491 | Predicate Device<br>Air Relax Plus<br>Model AR-3.0<br>K211460 | Comment | | Arm<br>Attachment | Yes<br>Size "1" : 34 X 15.35<br>Size "2" : 39.3 X 15.35 | Yes<br>Size "1" : 34 X 15.35<br>Size "2" : 39.3 X 15.35 | Identical in size<br>and materials.<br>Number of<br>Inflatable garment<br>segments differs. | | Shorts<br>Attachment | Yes<br>Size "1" : 20.8 X 32.5<br>Size "2" : 24.6 X 32.5 | Yes<br>Size "1" : 20.8 X 32.5<br>Size "2" : 24.6 X 32.5 | Identical in size<br>and materials.<br>Number of<br>Inflatable garment<br>segments differs. | | Number of<br>Inflatable<br>garment<br>segments | 6 | 4 | No impact on<br>safety and<br>effectiveness | | Weight | 2.2 kg (4.85 pounds) | 1.67kg (3.7 pounds) | Weight is<br>different but it<br>does not affect<br>safety and<br>effectiveness. | | Dimensions<br>(W x H x D) | 7.7" x 7.1" x 10.4" | 9.5" x 4.7" x 7.5" | Size is different<br>but it does not<br>affect safety and<br>effectiveness. | | Housing<br>Materials and<br>Constructions | Molded ABS enclosure | Molded ABS enclosure | Identical | | Patient<br>contact | Non-conductive garments | Non-conductive garments | Identical | | Safety<br>Features | Button at control unit<br>allows user to stop or<br>pause therapy session at<br>any time. | Button at control unit<br>allows user to stop or<br>pause therapy session at<br>any time. | Identical | | Modes | 4 Modes :<br>"PROG" mode inflates<br>and deflates chambers<br>from bottom up, one at a<br>time<br>"SEQT" mode also<br>inflates chambers from<br>bottom up, but maintains<br>pressure in lower<br>chambers as works its | 4 Modes :<br>"P" mode inflates<br>and deflates chambers<br>from bottom up, one at a<br>time<br>"S" mode also inflates<br>chambers from bottom<br>up, but maintains pressure<br>in lower chambers as<br>works its way to top. | Similar to<br>predicate.<br>Differences do<br>not affect safety<br>and effectiveness. | | Model Name<br>510(k)<br>Number | Subject Device<br>Air Relax Pro<br>Model AR-4.0<br>K212491 | Predicate Device<br>Air Relax Plus<br>Model AR-3.0<br>K211460 | Comment | | | "OVLAY" mode is<br>inflates all chambers and<br>maintained pressure at<br>same time and release<br>pressure all chambers.<br>"DRAIN" mode is mixed<br>mode of SEQT and<br>PROG | "F" mode is inflates all<br>chambers and maintained<br>pressure at same time and<br>release pressure all<br>chambers.<br>At "Target" mode, user<br>can select specific<br>chamber to inflates | | | Treatment<br>Duration | 5-95 minutes | 15 or 30 minutes | Extended duration<br>for subject device<br>but predicate time<br>can be re-enabled<br>any number of<br>times so no<br>significant<br>difference | ## Table of the Similarities and Differences of Subject vs. Predicate Device {6}------------------------------------------------ # 510(k) Summary Page 4 of 7 {7}------------------------------------------------ ## 510(k) Summary Page 5 of 7 ## Substantial Equivalence Discussion In the above detailed table we have compared the Air Relax Pro Model AR-4.0 to the predicate for equivalence of: ## Indications - The Air Relax Pro Model AR-4.0 is intended 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 Relax Pro Model AR-4.0 simulates kneading and stroking of tissues by using an inflatable garment. These indications are identical to the predicate. Prescriptive - The Air Relax Pro Model AR-4.0 is OTC as is the predicate Design, Technology and Principle of Operation - The Air Relax Pro Model AR-4.0 has equivalent design and features when compared to the predicate and have identical technology to the predicate Performance and Specifications - The Air Relax Pro Model AR-4.0 has equivalent specifications of performance when compared to the predicate. Compliance with standards – The Air Relax Pro Model AR-4.0 declares compliance with IEC 60601-1, IEC 60601-1-11 and IEC 60601-1-2 which is identical to the predicate. {8}------------------------------------------------ ### 510(k) Summary Page 6 of 7 ## Materials - The patient contacting materials of the Air Relax Pro Model AR-4.0 are the inflatable garments which are identical to the predicate device 510(K) K211460 ### Patient Population - The Air Relax Pro Model AR-4.0and predicate are indicated for adults ### Environment of Use - The Air Relax Pro Model AR-4.0 and predicates are for use in clinics, hospital, athlete training, and home environments. ### Differences - There are no differences between the proposed device and the predicate device that raise any new safety and efficacy concerns. ## Performance Testing #### Bench: The device has been tested to insure that it all requirements have been met, this includes: - Testing of all controls - Testing of all indicators ● - Testing of performance ● The device has also been tested to the requirements of the following standards: - . AAMI / ANSI ES60601-1:2005 + A1: 2012 Medical electrical equipment part 1: general requirements for basic safety and essential performance - IEC 60601-1-2: 2014 Collateral standard: Electromagnetic Disturbances -. Requirements and Tests - . IEC 60601-1-11: 2015, Collateral standard: requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment ### Animal: No animal testing was performed {9}------------------------------------------------ ### 510(k) Summary Page 7 of 7 ## Clinical: No clinical testing was performed ## Differences - There are no differences between the proposed device and the predicate device that raise any new safety and efficacy concerns. ## Substantial Equivalence Rationale The Air Relax Pro Model AR-4.0 is viewed as substantially equivalent to the predicate device because: Indications - are identical to the predicate Prescriptive – The Air Relax Pro Model AR-4.0 and predicate are OTC. Design. Technology and Principle of Operation - The Air Relax Pro Model AR-4.0 has equivalent design and features when compared to the predicate and have the identical technology to the predicate. Performance and Specifications - The Air Relax Pro Model AR-4.0 has equivalent specifications of performance when compared to the predicate. Compliance with standards - The Air Relax Pro Model AR-4.0 declares compliance with IEC 60601-1, IEC 60601-1-11 and IEC 60601-1-2 which is identical to the predicate Materials - The patient contacting materials of the Air Air Relax Pro Model AR-4.0 are are identical to the predicate. Environment of Use - Clinics, hospital, athlete training, and home environments, identical to the predicate. Features - The Air Relax Pro Model AR-4.0 has equivalent features when compared to the predicate. ## Conclusion The Air Relax Pro Model AR-4.0 is substantially equivalent to the predicate in: indications for use, patient population, environment of use, technology characteristics, materials, specifications / performance and compliance with international standards. Minor differences as detailed in the substantial equivalence table above do not raise questions of safety and effectiveness.