Powered Inflatable Tube Massager - SLIM UP DRAIN

K201730 · Foggiare Technologies, LLC · IRP · Aug 22, 2022 · Physical Medicine

Device Facts

• Record ID: K201730
• Device Name: Powered Inflatable Tube Massager - SLIM UP DRAIN
• Applicant: Foggiare Technologies, LLC
• Product Code: IRP · Physical Medicine
• Decision Date: Aug 22, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5650
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The IAF-SYSTEM is intended 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. IAF-SYSTEM simulates kneading of tissues by using an inflatable garment.

Device Story

IAF-SYSTEM is a powered inflatable tube massager for use in clinics, hospitals, athlete training, or home environments. The system comprises an air pump, air pressure sensor, microprocessor, and inflatable sleeves (leg, hip, or arm attachments) connected via hoses. Each sleeve contains four compression chambers. The device operates by sequentially inflating and deflating these chambers to simulate kneading and stroking of tissues, moving from limb end to body center. Users select therapy times (10, 20, 25, or 30 minutes) and pressure levels (0-119 mmHg). The microprocessor controls the timing and pressure based on sensor feedback to ensure safe operation. A user-accessible button allows for immediate pause or stop of the therapy session. The device provides non-invasive, mechanical compression to assist with muscle recovery and circulation, offering a similar therapeutic effect to established compression therapy systems.

Clinical Evidence

No clinical data. Safety and effectiveness were demonstrated through bench testing, including electrical safety (IEC 60601-1), EMC testing, and functional performance testing of the air pump, pressure sensors, and inflation cycles.

Technological Characteristics

Powered inflatable tube massager; 4-chamber sequential compression; 120V power source; 0-119 mmHg pressure range; microprocessor-controlled; molded ABS enclosure; nylon/polyurethane laminate sleeves. Connectivity: Standalone. Standards: ANSI AAMI ES60601-1, IEC 60601-1-2. Sterilization: Not applicable (non-direct contact).

Indications for Use

Indicated for healthy individuals seeking temporary relief of minor muscle aches and pains and temporary increase in circulation to treated areas via simulated tissue kneading and stroking.

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)

Submission Summary (Full Text)

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August 22, 2022

Foggiare Technologies LLC % Jay Mansour Principal Mansour Consulting LLC 845 Aronson Lake Court Roswell, Georgia 30075

Re: K201730

Trade/Device Name: IAF-SYSTEM Regulation Number: 21 CFR 890.5650 Regulation Name: Powered Inflatable Tube Massager Regulatory Class: Class II Product Code: IRP Dated: July 6, 2022 Received: July 7, 2022

Dear Jay Mansour:

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,

Tushar Bansal, PhD Acting Assistant Director, Acute Injury Devices Team DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) K201730

Device Name IAF-SYSTEM

Indications for Use (Describe)

IAF-SYSTEM is intended 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. IAF-SYSTEM simulates kneading of tissues by using an inflatable garment.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|--|
|-------------------------------------------------|--|

Prescription Use (Part 21 CFR 801 Subpart D)

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

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# 510(k) #K201730

# 510k Summary:

As required by 21 CFR 807.92 (c)

1 - Date Summary Prepared: August 13, 2022

- 2 Owner/Submitter/Sponsor/Applicant information:
#### OWNER/SUBMITTER/SPONSOR/APPLICANT

Contact name: Edouard Sezionale- Foggiare Technologies LLC Title: owner/CEO Telephone: [phone] Email address: [e-mail] Address: 426 E Palmetto Park Rd. Boca Raton, FL 33432 USA

### APPLICATION CORRESPONDENT

Contact name: Jay Mansour, MSQA, BE, RAC- Mansour Consulting LLC Title: regulatory consultant- Principal Telephone: [phone] Email address: [e-mail] Address: 845 Aronson Lake Court Roswell, GA 30075 USA

#### 3 - Device Information:

Common/usual/classification name:

massager, powered inflatable tube

Device name:

| | Device Model Name | Model Number |
|---|-------------------|-------------------|
| 1 | IAF-SYSTEM | (NO MODEL NUMBER) |

| FDA 3 Letter Code | IRP |
|-------------------------------|-------------------|
| FDA regulation number: 21 CFR | 890.5650 |
| Regulation medical specialty | Physical Medicine |
| Review panel | Physical Medicine |
| Class | 2 |

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#### 4 - Substantial equivalency is claimed against the following predicate device(s):

| 510k<br>Number | Trade or Proprietary or Model Name | Manufacturer | Primary Predicate |
|----------------|-----------------------------------------|-------------------------------------------|-------------------|
| k182668 | Rapid Reboot Compression Therapy System | Rapid Reboot<br>Recovery<br>Products, LLC | Yes |

#### 5 - Description of the device

Subject 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 four (4) compression chambers. The compression massage direction is from limb end to body center. 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

#### 6 - Intended Use + indications for use

| Intended Use: | The IAF-SYSTEM is intended for the temporary relief of minor muscle aches<br>and pains and for the temporary increase in circulation to the treated areas in |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|
| indications for use: | people who are in good health. The IAF-SYSTEM simulates kneading and<br>stroking of tissues by using an inflatable garment. |

#### 7 - Basis for determination of substantial equivalency:

(a) Indications for use:

The indication for use is identical to the predicate's.

#### (b) Technological characteristics:

The technological characteristics are substantially equivalent to the predicate device, meeting the same technical standards.

Substantial equivalency between our device and predicate device is tabulated below:

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| Device | Subject Device<br>Primary Predicate | | Comparison |
|------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | DAM SRL | Rapid Reboot Recovery<br>Products, LLC | NA |
| 510(k)<br>Number | TO BE DETERMINED | K182668 | NA |
| Model Name | IAF-SYSTEM | Rapid Reboot Compression<br>Therapy System | NA |
| Classification | Class II Device,<br>IRP (21 CFR890.5650) | Class II Device, IRP (21 CFR890.5650) | Same |
| Indications for<br>Use (IFU) | The IAF-SYSTEM is intended for the<br>temporary relief of minor muscle aches<br>and pains and for the temporary increase<br>in circulation to the treated areas in<br>people who are in good health. The IAF-<br>SYSTEM simulates kneading and stroking<br>of tissues by using an inflatable garment. | The Rapid Reboot<br>Compression Therapy System is<br>intended for the temporary relief of<br>minor muscle aches and pains and for<br>the temporary increase in circulation<br>to the treated areas in people who<br>are in good health. The Rapid Reboot<br>Compression Therapy System<br>simulates kneading and stroking of<br>tissues by using an inflatable<br>garment. | Same |
| OTC or Rx | OTC | OTC | Same |
| Environment<br>of Use: | Clinics, hospital, athlete training, and<br>home environment. | Clinics, hospital, athlete training, and<br>home environments | Same |
| Standards | ANSI AAMI ES60601- 1:2005/ (R)2012 And<br>A1:2012<br>IEC 60601-1-2 Edition 4.0<br>2014-02 | IEC 60601-1:2014; IEC<br>60601-1-2:2014 | Same |
| | Biocompatibility not required | EN ISO 10993-5:2009 & EN ISO<br>10993-10:2010 | Different.<br>Biocompatibility<br>not required for<br>subject device, as<br>users wear<br>clothing under<br>the garments. No<br>direct contact |
| Mode of<br>Compression | Sequential"Seawave"/ Peristaltic | Sequential/Peristaltic | Same |
| Power<br>Source | 120 V, 50Hz | 120V, 60Hz | Same |

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| Therapy Time | User determines therapy<br>time. Choose from 10, 20,25 or 30<br>minute session time. | User determines therapy<br>time. Choose from 10, 20, or 30<br>minute session time, with option<br>to add additional 10 minutes to<br>any therapy time. | Same |
|-------------------------------------------------------------|--------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------|
| Max Pressure<br>Min Pressure | 0-119 mmHg | 0-200 mmHg | Different.<br>Subject device<br>provides<br>substantially<br>equivalent<br>pressure, despite<br>the different<br>maximum<br>pressure |
| Number of<br>Chambers | 4 Chambers | 4 Chambers | Same |
| Compression<br>Applicator<br>Garments<br>Sleeve<br>Material | Nylon with a Polyurethane laminate | Nylon with a Polyurethane<br>laminate | Same |
| Housing<br>Materials<br>And<br>Constructions | Molded ABS enclosure | Molded ABS enclosure | Same |
| Patient contact | Non-conductive attachments | Non-conductive attachments | Same |
| Power<br>Consumption | 400 W | 30W | Different due to<br>physical<br>configuration |

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| Cycle time | Leg (consisting of foot, calf, knee, upper | | | | | | 1 min 20 sec | Same and different |
|------------|-----------------------------------------------------------------------------------------|--------------------------------------------|------------|------------|------------|-----------------------------------------------------|--------------|-----------------------------------------------------|
| | leg) | | | | | | | depending on the |
| | The cycle time for all programs is | | | | | | | program. See |
| | tabulated below. | | | | | | | below. |
| | The first cycle can be different from the | | | | | | | |
| | following ones, because it starts with | | | | | | | Information below |
| | | | | | | totally empty sectors, while the following | | lists 1st cycle, |
| | | cycles can start with some air in the | | | | | | subsequent cycle |
| | | | | | | | | |
| | | cycles change over the course of the | | | | sectors; moreover, in many programs the | | and predicate cycle,<br>respectively, all in |
| | | | | | | | | |
| | | program. This is illustrated within the | | | | | | seconds, comparing |
| | | user manual.<br>minutes | | | | | | each of the 12 |
| | | | | | | | | programs with the |
| | Prog. | Treatment | Sector | cycle | cycle | subsequent | | predicate cycle |
| | n.<br>ਹੈ | time<br>25 | pause<br>ਹ | pause<br>3 | time<br>50 | cycle time<br>38 | | time: |
| | 2 | 25 | 1 | 3 | 47 | ਚ ਹ | | Program 1: 50 / 38 / 80 |
| | m | 25 | ਹੈ | 3 | ರೇ | 33 | | Program 2: 47 / 41 / 80 |
| | বাঁ | | | 4 | ਚਰੇ | | | Program 3: 46 /33 / 80 |
| | | 25 | 2 | | | ਤੌਰੇ | | Program 4: 49 / 39 / 80 |
| | ട | 25 | 2 | 4 | ਦਰੇ | eo | | Program 5: 69 / 60 / 80 |
| | б | 25 | 2 | 4 | 80 | e8 | | Program 6: 80 / 68 / 80 |
| | 7 | 25 | 1 | 3 | 97 | 35 | | Program 7: 97 / 35 / 80 |
| | 8 | 30 | 1 | 3 | 260 | 140 | | Program 8: 260/140/80 |
| | | | | | | | | Program 9: 65 / 98 / 80 |
| | ਰੇ | 25 | ਹ | 3 | દર | ಕಿ8 | | Program 10: 206/203/80 |
| | 10 | 20 | 2 | 4 | 206 | 203 | | Program 11: 34 / 28 /80<br>Program 12: 34 / 33 / 80 |
| | 11 | 30 | 2 | 3 | 34 | 28 | | |
| | 12 | 20 | 2 | 3 | 34 | 33 | | Program 6 provides the |
| | | | | | | | | same exact (1st) cycle |
| | | | | | | The cycle time is the time needed to fill air in | | time as predicate device. |
| | | the sectors with set pressure in the set | | | | | | |
| | | sequence + sectors pause. | | | | | | All other programs offer |
| | | | | | | | | substantially the same |
| | | | | | | Sector pause is the time between the end of | | cycle time, varying |
| | | | | | | fill in of air in a sector and the start of fill in | | between 34 and 260 |
| | | of the air in the sequel one. | | | | | | seconds (for 1st cycle) and |
| | | | | | | The cycle pause is the time between the end | | between 33 and 203 |
| | | of a cycle and the start of the next one. | | | | | | seconds (for subsequent |
| | | | | | | 1st cycle time is the time needed for the 1st | 3 | cycles). |
| | | complete cycle (it needs a little more | | | | | | The differences in cycle |
| | | because start with total empty sectors). | | | | | | times are within the |
| | | | | | | Subsequent cycle time is the time need for | | same order of magnitude |
| | | | | | | other cycles ( being little bit shorter because | | as predicate device, and |
| | | the sectors are not totally empty). | | | | | | do not raise new |
| | | Exception in program 9: This program | | | | | | concerns. |
| | | includes a first section where the plantar | | | | | | |
| | | | | | | | | |
| | thrust provides pressure starting from the<br>bottom-base of the thigh, then mid-thigh, | | | | | | | |
| | then knee and calf, and finally knee and | | | | | | | |
| | ankle. The effect is therefore drainage from | | | | | | | |
| | the top. After that, it starts a treatment like | | | | | | | |
| | program 1. | | | | | | | |

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| Size | 49″ x 21″ x 14.5″ | 10″ x 6.5″ x 5″ | Same.<br>(Tabletop or<br>handheld portable) |
|------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------|
| Weight | 77 pounds with base | 5.8 pounds | Different due to physical<br>configuration |
| Modes (Inflation<br>sequences, all<br>preprogrammed) | 2 modes: "A" mode inflates and deflates<br>chambers from bottom up (distal to<br>proximal chambers), one at a time. "B"<br>mode also inflates chambers from<br>bottom up, but maintains pressure in<br>selected chambers as works its way to<br>top. Then all chambers release pressure<br>at same time once all chambers have<br>sequentially inflated. | 2 modes: "A" mode inflates and<br>deflates chambers from bottom up<br>(distal to proximal chambers), one<br>at a time. "B" mode also inflates<br>chambers from bottom up, but<br>maintains pressure in lower<br>chambers as works its way to top.<br>Then all chambers release pressure<br>at same time once all chambers<br>have sequentially inflated. | Same.<br>Both devices have<br>sequential mode<br>(distal to<br>proximal<br>chambers). |

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| Modes (visual<br>description) | "Sequential:" | Mode A: | Same |
|-------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | <br>With "lock" on specific area | | |
| | Mode seawave: | Mode B: | Same<br>The machine<br>permits applying<br>a set pressure in<br>a targeted way<br>to each single<br>"lock" sector to<br>determine the<br>effect and<br>effectiveness on<br>the patient.<br>One or more<br>sectors can be<br>kept under<br>pressure so that<br>during program<br>execution, these<br>do not deflate<br>during the cycle. |
| | <br>"SEA WAVE" LEG-PIECE<br>With overlapping bands, pressure which decreases towards<br>the top and programmable control of sectors,<br>the flow is physiological. | | |

4

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| "Leg" Attachment | Leg (consisting of foot, calf, knee, upper leg) | Leg (consisting of foot, calf, knee, upper leg) | Same |
|--------------------------|----------------------------------------------------------|-----------------------------------------------------------------------------------------------------|---------------------------------|
| Leg Attachment<br>Photos | Image: Leg attachment photo | Image: Leg attachment photo | Same |
| Leg Attachment<br>Sizes | 51"x 26" | 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" | Different.<br>Slight variation. |
| "Hip" Attachment | Hip (consisting of upper legs, glutes, hips, lower back) | Hip (consisting of upper legs, glutes, hips, lower back) | Same |

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| "Arm"<br>Attachment | Arm (consisting of entire<br>arm, shoulder, upper chest and back) | Arm (consisting of entire arm,<br>shoulder, upper chest and back) | Same |
|-------------------------------------------|--------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|-------------------------------|
| Arm Attachment<br>Photos | 66 cm<br>72 cm | | Same. |
| Arm Attachment<br>Sizes | One size: 26" x 28 "<br>72 cm<br>65 cm | Regular: 18" x 38"<br>Long: 18" x 44" | Same.<br>Slight<br>variation. |
| Safety Features | Button on display allows user to stop or<br>pause therapy session at any time. | Button on display allows user to<br>stop or pause therapy session at<br>any time. | Same |
| SW/Firmware/<br>Microprocessor<br>Control | Microprocessor | Microprocessor | Same |
| Technology | Compressor and valve system which<br>sequentially inflates cells of appliance | Compressor and valve system<br>which sequentially inflates cells of<br>appliance | Same |

(c) Non-clinical tests- brief discussion:

Safety testing and EMC testing successfully completed. In particular, the following tests were performed:

- 1- Earth circuit continuity test, leakage current, current absorption, current absorption: Summary of findings- device complies with these IEC 60601-1 safety requirements, in the lab as well as on production units (tests are conducted on on-going basis).
- 2- Main switch, air hose connector, delivered pressure, display function, programs, top card function, safety pressure switch intervention, maximum setting pressure, integrity of the inflatable parts (multiple)

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Summary of findings- device complies with the acceptance criteria of these various tests, documenting that safety and effectiveness are achieved on validation units and on production units (tests are conducted on on-going basis).

(d) Clinical tests- brief discussion

Not applicable. No clinical tests were conducted.

(e) Non-clinical and clinical tests- conclusions drawn demonstrating that the device is as safe and as effective, and performs as well as the predicate device(s): Safety of subject device is confirmed via testing. Effectiveness is ensured by similar parameter of a well-understood device mechanism.