Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description mentions a microprocessor and software controlling timing and pressure based on a sensor, which is standard automation, not AI/ML. There are no mentions of AI, ML, DNN, training data, or performance metrics typically associated with AI/ML.

Therapeutic

Yes
The device is described as "intended for the temporary relief of minor muscle aches and pains" and directly addresses a health-related condition.

Diagnostic

No

The device is intended for temporary relief of muscle aches and pains and increased circulation, which are therapeutic rather than diagnostic purposes.

SaMD (Software as a Medical Device)

No

The device description explicitly states it consists of an air pump, air pressure sensor, and sleeves, which are hardware components. The software controls these hardware components, but the device itself is not solely software.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is for the temporary relief of muscle aches and pains and increasing circulation. This is a physical therapy/massage type of application, not a diagnostic test performed on biological samples.
Device Description: The device works by applying external pressure through inflatable sleeves. It does not involve analyzing any biological samples (like blood, urine, tissue, etc.).
Lack of IVD Characteristics: There is no mention of analyzing samples, detecting biomarkers, or providing diagnostic information about a disease or condition.

IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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.

Product codes (comma separated list FDA assigned to the subject device)

IRP

Device Description

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

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Clinics, hospital, athlete training, and home environment.

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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)
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).

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K182668

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 890.5650 Powered inflatable tube massager.

(a)
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.(b)
Classification. Class II (performance standards).

Summary

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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food & Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol is a stylized representation of a human figure, while the FDA name is written in blue and includes the words "U.S. Food & Drug Administration".

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

1

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,

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

2

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: (561) 923-9161 Email address: thierry@foggiare.com 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: (678) 908-8180 Email address: jay@mansourconsulting.com 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

4

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

| 510k

Number	Trade or Proprietary or Model Name	Manufacturer
K182668	Rapid Reboot Compression Therapy System	Rapid Reboot
Recovery
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
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
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:

5

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

6

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

7

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,
respectively, all in

		program. This is illustrated within the						seconds, comparing
		user manual.
minutes						each of the 12
								programs with the
	Prog.	Treatment	Sector	cycle	cycle	subsequent		predicate cycle
	n.
ਹੈ	time
25	pause
ਹ	pause
3	time
50	cycle time
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
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
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.

8

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

9

| Modes (visual

description)	"Sequential:"	Mode A:	Same

With "lock" on specific area
	Mode seawave:	Mode B:	Same
The machine
permits applying
a set pressure in
a targeted way
to each single
"lock" sector to
determine the
effect and
effectiveness on
the patient.
One or more
sectors can be
kept under
pressure so that
during program
execution, these
do not deflate
during the cycle.

"SEA WAVE" LEG-PIECE
With overlapping bands, pressure which decreases towards
the top and programmable control of sectors,
the flow is physiological.

4

10

"Leg" Attachment	Leg (consisting of foot, calf, knee, upper leg)	Leg (consisting of foot, calf, knee, upper leg)	Same
Leg Attachment
Photos	Image: Leg attachment photo	Image: Leg attachment photo	Same
Leg Attachment
Sizes	51"x 26"	X-Short: 14" x 41"
Short: 14" x 43"
Medium: 14" x 45"
Long: 14" x 48"
X-Long: 14" x 52"	Different.
Slight variation.
"Hip" Attachment	Hip (consisting of upper legs, glutes, hips, lower back)	Hip (consisting of upper legs, glutes, hips, lower back)	Same

11

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

12

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.